Prospective Clinical StuDy of Tri-planar Tarsometatarsal (TMT) ArthroDesis With Early Weight-Bearing After Lapiplasty® ProceDure Through a Mini-Incision™ Approach (Mini3D)
Phase: NA
Conditions: Hallux Valgus, Bunion
Sponsor: Treace Medical Concepts, Inc.

Study Protocol 
Title: ProspecƟve Clinical StuDy of Tri-planar Tarsometatarsal (TMT) ArthroDesis with Early Weight-
Bearing aŌer Lapiplasty® ProceDure through a Mini-Incision™ Approach (Mini3D) 
NCT number: NCT05082012 
Document Date: April 4, 2023 

 
 
 
Study Number: CP2021-1 
CONFIDENTIAL 
Page 1 of 81 
Record: Clinical Study Protocol 
 
 
Version date: 04/Apr/2023 / Rev: E 
 
 
Treace Medical Concepts, Inc. 
100 Palmetto Park Place 
Ponte Vedra, FL  32081 
 
The Mini3D™ Study 
CLINICAL STUDY PROTOCOL 
Study Number:  CP2021-1 
Version date: 26Aug2021 / Rev: E 
 
Regulatory Classification: 
 
Check One: 
 IDE 
 Exempt 
 Post-Market Surveillance 
 
Name of Finished Product(s): 
Mini-Incision™ Precision Instrument Set 
Lapiplasty® Mini-Incision™ System   
 
Sponsor’s Medical Monitor: 
Robert D. Santrock, MD  
 
Lead Principal Investigator: 
Jody McAleer, DPM, FACFAS 
Jefferson City Medical Group 
Department of Podiatry 
 
 
This study will be performed in compliance with the 21 CFR Parts 11 (Electronic Records; Electronic 
Signatures), 50 (Protection of Human Subjects), 56 (Institutional Review Boards), and 803 (Medical 
Device Reporting), International Conference on Harmonization (ICH) Guideline E6 for Good Clinical 
Practice (GCP); Declaration of Helsinki; Health Insurance Portability and Accountability Act (HIPAA) 
regulations; and Applicable state and local laws and regulations.  
CONFIDENTIALITY STATEMENT 
This document is a confidential communication of Treace Medical Concepts (TMC), Inc.  
The recipient agrees that no unpublished information contained herein will be published or 
disclosed without prior written approval of TMC, Inc. except that this document may be 
disclosed to appropriate IRB or Ethics Committees or duly authorized representatives of 
the U.S. Food and Drug Administration or other responsible regulatory authorities under 
the condition that they are requested to keep it confidential.  It should be held confidential 
and maintained in a secure location.  It should not be copied or made available for review 
by any unauthorized person or firm. 
 
 

 
 
 
Study Number: CP2021-1 
CONFIDENTIAL 
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Record: Clinical Study Protocol 
 
 
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INVESTIGATOR SIGNATURE PAGE 
I have read, understood, and agree to: 
• 
Ensure that the requirements for obtaining informed consent are met; 
• 
Conduct the clinical study in accordance with this protocol, including applicable local/state laws 
and regulations; 
• 
Adhere to the publication policy of Treace Medical Concepts, Inc, as stated in the Clinical Study 
Agreement (CSA), for data collected during this study; 
• 
Ensure that all associates, colleagues, and employees assisting in the conduct of the study are 
informed of their obligations in meeting the above commitments; 
• 
Complete all Case Report Forms and study documentation and relevant imaging assessments (as 
required) promptly to the Sponsor, TMC, Inc., or its authorized representatives. 
 
I will ensure that the IRB review complies with governmental requirements and will be responsible for 
the initial and continuing review and approval of the clinical investigation.  I also agree to promptly report 
to the IRB all changes in the research activity and all unanticipated problems involving risks to human 
subjects or others.  Additionally, I will not make any changes in the research without sponsor and IRB 
approval of an amended protocol, except where necessary to eliminate apparent immediate hazards to 
human subjects. 
 
I agree to comply with all other requirements regarding the obligation of clinical investigators and all 
other pertinent requirements of the sponsor and government agencies. 
 
Investigator Signature:  I have read and understood the contents of this protocol.  I agree to follow and 
abide by the guidelines set forth in this document. 
 
 
 
 
 
 
 
 
Signature of Principal Investigator 
 
Date 
 
 
 
 
Printed Name of Principal Investigator 
Please scan, email or fax this signed page to: 
Cara Bethell 
Treace Medical Concepts, Inc 
Cell: 901-229-2762 
Fax: 904-834-7169 
eMail: cbethell@treace.net   
 
PLEASE RETAIN THE ORIGINAL IN YOUR STUDY RECORDS 
 

 
 
 
Study Number: CP2021-1 
CONFIDENTIAL 
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Record: Clinical Study Protocol 
 
 
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CLINICAL STUDY PROTOCOL SYNOPSIS 
Protocol Name: 
The Mini3D™ Study 
Protocol Number: 
CP2021-1 
Protocol Title: 
Prospective Clinical StuDy of Tri-planar Tarsometatarsal (TMT) ArthroDesis with 
Early Weight-Bearing after Lapiplasty® ProceDure through a Mini-Incision™ 
Approach (The Mini3D™ Study) 
Name of Finished 
Product(s): 
Mini-Incision™ Precision Instrument Set 
Lapiplasty® Mini-Incision™ System   
Development Phase: 
Exempt, post market 
Study Design: 
This is a prospective, multicenter, unblinded study 
Indication(s) of 
Device: 
All medical devices used during this study are cleared for commercial distribution 
and are to be used in accordance with approved product labeling. 
The TMC Plating System is intended for use in stabilization of fresh fractures, 
revision procedures, joint fusion and reconstruction of small bones of the feet. The 
system can be used in both adult and pediatric patients aged >12 years. In the foot, 
the system can be used for the following specific examples:  
• First metatarsal osteotomies for hallux valgus correction such as:  
• Opening base wedge osteotomy 
• Closing base wedge osteotomy  
• Crescentic osteotomy  
• Proximal Chevron osteotomy  
• Distal Chevron osteotomy (Austin)  
• First metatarsal fracture fixation  
• Arthrodesis of the first metatarsalcuneiform joint (Lapidus Fusion)  
• Flatfoot Osteotomies  
• Lateral Column Lengthening (Evans Osteotomy)  
• Plantar Flexion Opening Wedge Osteotomy of the Medial Cuneiform 
(Cotton Osteotomy)  
• Mid / Flatfoot Fusions  
• LisFranc Arthrodesis and/or Stabilization  
• 1st (Lapidus), 2nd, 3rd, 4th, and 5th Tarsometatarsal (TMT) Fusions  
• Intercuneiform Fusions • Navicular-Cuneiform (NC) Fusion  
• Talo-Navicular (TN) Fusion  
• Calcaneo-Cuboid (CC) Fusion  
• Medial Column Fusion  
• Arthrodesis of the first metatarsophalangeal joint (MTP) 
 

 
 
 
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Objective(s):  
The objectives of this study are to evaluate outcomes of the Lapiplasty® Procedure 
using the Lapiplasty® Mini-Incision™ System for patients in need of hallux valgus 
surgery:  
1. To determine radiographic recurrence of hallux valgus and the timing of 
failure following hallux valgus correction with the Lapiplasty® 
Procedure. 
2. To determine whether the Lapiplasty® Procedure effectively corrects 
anatomical alignment of the 1st metatarsal and sesamoids in all three 
planes. 
3. To assess whether early weight-bearing (WB) after the Lapiplasty® 
Procedure affects the union rates or causes loss of 3-plane correction. 
4. To evaluate the quality of life and pain scores following the Lapiplasty® 
Procedure.  
Number of Subjects: 
Up to 200 subjects will be treated in this study  
Sites: 
Up to 20 sites  
Patient Population: 
Patients 14 years through 58 years with symptomatic hallux valgus will be eligible to 
participate based on the inclusion and exclusion criteria defined in this protocol.  
Inclusion Criteria: 
 
 
Patients satisfying the following criteria will be considered the screening population 
and will be eligible for participation: 
1. Male and females between the ages 14 and 58 years at the time of consent; 
2. Closed physeal plates at the time of consent; 
3. Intermetatarsal angle is between 10.0˚ - 22.0˚; 
4. Hallux valgus angle is between 16.0˚ - 40.0˚; 
5. Willing and able to adhere to early weight-bearing instructions post-
operatively; 
6. Capable of completing self-administered questionnaires; 
7. Acceptable surgical candidate, including use of general anesthesia; 
8. Female patients must be of non-childbearing potential or have a negative 
pregnancy test within 7 days prior to index procedure; 
9. Willing and able to schedule index procedure within 3 months of consent and 
able to return for scheduled follow-up visits; 
10. Willing and able to provide written informed consent. 
Exclusion Criteria: 
Patients satisfying the following criteria will not be eligible for participation: 
1. Previous surgery for hallux valgus on operative side; 
2. Previous surgeries on operative foot involving fusion of foot or ankle joints 
(other than hammertoe or lesser toes/digits); 
3. Additional concomitant procedures outside of the 1st ray; 

 
 
 
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4. Moderate or Severe osteoarthritis of the MTP joint based on radiographic 
imaging (including lack of evident crista) or positive grind test; 
5. Symptomatic flatfoot or asymptomatic flatfoot (defined as calcaneal 
inclination <5˚and talonavicular subluxation/uncovering >50%); 
6. BMI >40 kg/m²; 
7. Current nicotine user, including current use of nicotine patch; 
8. Current clinical diagnosis of diabetes with fasting plasma glucose > 126 
mg/dL and/or HbA1c ≥7.0; 
9. Current clinical diagnosis of peripheral neuropathy or by assessment on 4-
point monofilament test; 
10. Current clinical diagnosis of fibromyalgia; 
11. Current clinical diagnosis of Complex Regional Pain Syndrome/Reflex 
Sympathetic Dystrophy (CRPS/RSD); 
12. Current uncontrolled hypothyroidism; 
13. Previously sensitized to titanium; 
14. Currently taking oral steroids or rheumatoid biologics; 
15. Currently taking immunosuppressant drugs; 
16. Insufficient quantity or quality of bone to permit stabilization, conditions that 
retard healing (not including pathological fractures) and conditions causing 
poor blood supply such as peripheral vascular disease; 
17. Active, suspected or latent infection in the affected area; 
18. Use of synthetic or allogenic bone graft substitutes; 
19. Current diagnosis of metatarsus adductus (defined as MAA ≥ 23˚);  
20. Known keloid and hypertrophic scar forming; 
21. Scheduled to undergo a same-day bilateral procedure.  Patient agrees to 
refrain from the Lapiplasty® Procedure (or other hallux valgus procedures) 
on contralateral foot for minimum of 6 months post index procedure; 
22. Patient has previously been enrolled into this study for a contralateral 
procedure; 
23. Scheduled for any concomitant procedure that would alter patient’s ability to 
early weight-bear post-procedure; 
24. Patient requires an incision >4.0 cm to complete the procedure (determined 
pre-operatively or intra-operatively); 
25. Patient is actively involved with a workman's compensation case or is 
currently involved in litigation; 
26. Patient is currently or has participated in a clinical study in the last 30 days 
prior to signing informed consent or is considering participation in another 
research protocol during this study.  Exceptions to this include survey 
clinical studies with no treatment or if subject is greater than 12 months post 

 
 
 
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procedure in the Treace ALIGN3D™ study without ongoing protocol 
defined AE; these are not exclusionary; 
27. Patient has a condition or finding that, in the opinion of the Investigator, may 
jeopardize the patient’s well-being, the soundness of this clinical study, or 
could interfere with provision of informed consent, completion of tests, 
therapy, or follow-up. 
Study Duration:  
Anticipated subject duration will be 2 years post index procedure. 
Study Endpoints: 
 
Primary:  
Radiographic recurrence of hallux valgus deformity at 24 months for subjects with 
successful correction (defined as IMA <9.0°, HVA<15.0° and TSP as ≤ 3 at 6 weeks 
post-Lapiplasty® Procedure). Recurrence is defined by any two of the following 
three criteria being met at 24 months post-procedure: IMA of ≥12°, HVA ≥20° and 
TSP ≥4. 
Secondary: 
1. Change in radiographic angular/positional alignment before and after the 
Lapiplasty® Procedure [Time Frame: pre-operatively, 6 weeks, 4 months, 6 
months, 12 months, and 24 months, post-Lapiplasty® Procedure].   
2. Evaluate clinical/radiographic healing (union vs non-union). Non-union 
defined as lucency at TMT joint, hardware failure and/or loss of correction 
(recurrence), plus clinical pain at first TMT joint at 12 months post- 
Lapiplasty® Procedure. 
3. Clinical complications through 24-month follow-up visit due to the 
Lapiplasty® System Implants, the Lapiplasty® Procedure, the post-operative 
weight-bearing protocol or health conditions that could affect other outcome 
measures. 
4. Time to start weight-bearing in a boot, in days. 
5. Time to start weight-bearing in shoes, in days. 
6. Time to return to full unrestricted activity, in days. 
7. Change in pain at the base of the big toe (bunion related) assessed via a 
Visual Analog Scale (VAS) at 0-14 days, 14-21 days, 6 weeks, 4 months, 6 
months, 12 months and 24 months post-Lapiplasty® Procedure, in 
comparison to baseline visit pain.   
8. Change in Quality of Life, (PROMIS-29, PROMIS-25 and MOxFQ) defined 
as the total score measured at 6 months, 12 months and 24 months post-
Lapiplasty® Procedure, in comparison to baseline visit.  
9. Change in Range of Motion - 1st MTP dorsiflexion and plantarflexion at 12 
months and 24 months post-Lapiplasty® Procedure, in comparison to 
baseline visit.  
10. Change, if any, in initial incision length during Lapiplasty® Procedure.  
11. Change in radiographic foot length and width at 12 months post-Lapiplasty® 
Procedure in comparison to baseline visit.   

 
 
 
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12. Change in swelling at 6 weeks and 4 months post-Lapiplasty® Procedure as 
compared to 0-14 day visit.   
13. Change in scar quality at 4 months, 6 months, and 12 months post-
Lapiplasty® Procedure in comparison to baseline visit.  
14. Correlation between amount of time external positioner is actively used 
during Lapiplasty Procedure with necrosis, blistering, bruising and tissue 
ulceration events.   
Secondary Endpoints – Health Economic Outcomes  
All health economic endpoints are exploratory in nature. 
1. Complications below that are related to the Lapiplasty® Procedure or the 
Lapiplasty® System Implants requiring subsequent secondary surgical 
interventions, defined as the following: 1) deviations/delay from normal 
operative plan 2) readmission to hospital 3) return to operating room 4) 
unscheduled visits due to complications 5) employment of home health 
services; 
a. Revisions 
b. Hardware removals 
c. Reoperations 
d. Supplemental fixations 
e. Wound healing requiring surgical intervention 
f. Infection at surgical site requiring surgical intervention 
2. Time to return to work (or normal household activities if non-working), in 
days, while noting work status and work classification (sedentary, light 
work, medium work, heavy work, very heavy work). 
3. Time to return to full work, in days (or full household activities if non-
working), while noting work status and work classification (sedentary, light 
work, medium work, heavy work, very heavy work). 
4. Post-operative physical therapy requirements required for recovery of the 
Lapiplasty® Procedure. 

 
 
 
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TABLE OF CONTENTS 
 
Page 
1.0 
INTRODUCTION ............................................................................................................... 16 
2.0 
STUDY OBJECTIVES ....................................................................................................... 17 
3.0 
STUDY ENDPOINTS ......................................................................................................... 17 
4.0 
INVESTIGATIONAL PLAN ............................................................................................. 19 
4.1 
Overall Study and Design – Subject Disposition Diagram............................................... 19 
4.2 
Selection of Study Population ............................................................................................. 20 
4.2.1 
Recruitment .......................................................................................................................... 20 
4.2.2 
Enrollment and Treatment ................................................................................................. 20 
4.2.3 
Inclusion Criteria ................................................................................................................. 21 
4.2.4 
Exclusion Criteria ................................................................................................................ 21 
4.2.5 
Removal of Subjects from Study ........................................................................................ 22 
5.0 
PROCEDURE ...................................................................................................................... 23 
5.1 
General Description ............................................................................................................. 23 
5.2 
Lapiplasty® Procedure (Mini-Incision™ Approach)  (Index Procedure)...................... 24 
5.2.1 
Key Surgical Steps ............................................................................................................... 24 
5.3 
Post Index Procedure – Post-Operative Care and Weight-Bearing Instructions .......... 24 
5.4 
Pain Management ................................................................................................................ 25 
6.0 
IDENTITY OF STUDY DEVICES .................................................................................... 26 
6.1 
Product Accountability ....................................................................................................... 27 
7.0 
SUBJECT VISITS ............................................................................................................... 28 
7.1 
Visit 1 – Baseline .................................................................................................................. 28 
7.2 
Visit 2 –Index Procedure ..................................................................................................... 29 
7.3 
Visit 3 – 0-14 Day Follow-Up .............................................................................................. 30 
7.4 
Visit 4 – 14-21 Day Follow-Up (+ 3 days)........................................................................... 30 
7.5 
Visit 5 – 6 Week Follow-Up (± 2 weeks) ............................................................................. 30 
7.6 
Visit 6 – 4 Month Follow-Up (± 2 weeks) ........................................................................... 31 
7.7 
Visit 7 – 6 Month Follow-Up (± 1 month) .......................................................................... 31 
7.8 
Visit 8 - 12 Month Follow-Up (± 1 month) ......................................................................... 32 
7.9 
Visit 9 – 24 Month Follow-Up (± 2 months) ...................................................................... 32 
7.10 
Unscheduled Visit ................................................................................................................ 33 
7.11 
Study Exit ............................................................................................................................. 33 
7.12 
Study Visit Descriptions ...................................................................................................... 33 
8.0 
DATA MANAGEMENT AND INTEGRITY ................................................................... 37 
8.1 
Data Completion and Record Keeping .............................................................................. 37 
8.1.1 
Source Documents ............................................................................................................... 37 
8.1.2 
Data Collection ..................................................................................................................... 37 
8.1.3 
Data Correction ................................................................................................................... 38 
8.1.4 
Investigator Regulatory Binder .......................................................................................... 38 
8.1.5 
Study Correspondence ........................................................................................................ 38 
8.1.6 
Data Privacy ......................................................................................................................... 38 
8.1.7 
Record Retention, Inspection, and Custody ...................................................................... 39 
8.1.8 
Medical Dictionary Coding ................................................................................................. 39 

 
 
 
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8.1.9 
Data Quality Assurance ...................................................................................................... 39 
8.1.10 
Investigator Training - Protocol Specific Training........................................................... 39 
8.1.11 
Monitoring ............................................................................................................................ 40 
8.2 
Changes to Protocol, Protocol Deviations and Protocol Amendments ........................... 40 
8.2.1 
Changes to Protocol ............................................................................................................. 40 
8.2.2 
Protocol Deviations .............................................................................................................. 41 
8.2.3 
Protocol Amendments ......................................................................................................... 41 
9.0 
STATISTICAL CONSIDERATIONS ............................................................................... 41 
9.1 
Analysis of the Conduct of the Study ................................................................................. 42 
9.2 
Sample Size ........................................................................................................................... 42 
9.3 
Analysis Population ............................................................................................................. 42 
9.4 
Analysis of Study Endpoints ............................................................................................... 42 
9.5 
Missing Data ......................................................................................................................... 42 
9.6 
Interim Analyses .................................................................................................................. 43 
9.7 
Safety Analyses..................................................................................................................... 43 
9.8 
Detailed Analysis Plan ......................................................................................................... 43 
10.0 
SAFETY MONITORING ................................................................................................... 43 
10.1 
Adverse Events ..................................................................................................................... 44 
10.1.1 
Definition of an Adverse Event ........................................................................................... 44 
10.2 
Serious Adverse Events ....................................................................................................... 44 
10.2.1 
Definition of a Serious Adverse Event ............................................................................... 44 
10.2.2 
Subject Death ....................................................................................................................... 44 
10.2.3 
Adverse Event Classification .............................................................................................. 44 
10.2.4 
Reporting Adverse and Serious Adverse Events .............................................................. 45 
11.0 
PRODUCT COMPLAINTS................................................................................................ 46 
11.1 
Product Complaint Definition ............................................................................................ 46 
11.2 
Source of Product Complaint Data .................................................................................... 46 
11.3 
Medical Device Reporting and Product Complaints ........................................................ 46 
12.0 
STUDY OVERSIGHT ......................................................................................................... 47 
12.1 
Independent Oversight ........................................................................................................ 47 
BIBLIOGRAPHY .............................................................................................................................. 48 
13.0 
APPENDICES ...................................................................................................................... 49 
APPENDIX 1 – WORK CLASSIFICATION .................................................................................. 49 
APPENDIX 2 – VISUAL ANALOG SCALE................................................................................... 50 
APPENDIX 3 – QUALITY OF LIFE (QOL) TOOLS (PROMIS-29, PROMIS-25 AND MOXFQ) ....... 51 
APPENDIX 4 – RADIOGRAPHIC MEASUREMENTS ............................................................... 61 
APPENDIX 5 – RISK/BENEFIT ASSESSMENT ........................................................................... 71 
APPENDIX 6 – PRODUCT EXPERIENCE REPORT .................................................................. 73 
APPENDIX 7 – SUBJECT FOLLOW-UP VISIT CARD .............................................................. 73 
APPENDIX 8 – ADVERTISEMENT/FLIER FOR IRB APPROVAL ......................................... 75 
APPENDIX 9– THE PATIENT AND OBSERVER SCAR ASSESSMENT SCALE (POSAS) .... 76 
APPENDIX 10 – GENERAL SATISFACTION QUESTIONNAIRE ........................................... 80 
 
 
 

 
 
 
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KEY PROTOCOL-SPECIFIC ACRONYMS AND ABBREVIATIONS 
Acronyms/Abbreviation 
Terms 
AE 
Adverse Event 
AP 
Anteroposterior 
CORA 
Center of Rotational Angulation 
CRA 
Clinical Research Associate 
DJD 
Degenerative Joint Disease 
eCRF 
Electronic Case Report Form 
EDC 
Electronic Data Capture 
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practice 
HIPAA 
Health Insurance Portability and Accountability Act 
HV 
Hallux Valgus 
HVA 
Hallux Valgus Angle 
ICF 
Informed Consent Form 
IFU 
Instructions for Use 
ICH 
International Conference on Harmonization 
IMA 
Intermetatarsal Angle 
IRB 
Institutional Review Board 
MAA 
Metatarsus Adductus Angle 
MDR 
Medical Device Reporting 
MOxFQ 
The Manchester-Oxford Foot Questionnaire 
MTA 
Metatarsus Adductus 
MTP 
Metatarsophalangeal 
MTPJ 
Metatarsophalangeal Joint 
OA 
Osteoarthritis 
PE 
Physical Exam 
PHI 
Protected Health Information 
POSAS 
Patient and Observer Scar Assessment Scale 
PROMIS 
Patient-Reported Outcomes Measurement Information System 
ROM 
Range of Motion 
SAE 
Serious Adverse Event 
SAS 
Science Analysis System 
SOC 
Standard of Care 
SOP 
Standard Operating Procedures 
TMC 
Treace Medical Concepts 
TMT 
Tarsometatarsal 
TSP 
Tibial Sesamoid Position 
VAS 
Visual Analog Scale 
WB 
Weight-Bearing 

 
 
 
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Schedule of Assessments 
Study Activity 
 
Visit 1 
Visit 2 
Visit 3 
Visit 4 
Visit 5 
Visit 6 
Visit 7 
Visit 8 
Visit 9 
Study Exit 
Baseline 1 
 
Index 
Procedure 
0-14 Day 
follow-up 
 
14-21 
Day 
follow-up 
(+3 days) 
6 Week 
follow-up 
(+2 weeks) 
4 Month 
follow-up 
(+2 weeks) 
6 Month 
follow-up 
(+1 month) 
12 Month 
follow-up 
(+1 month) 
24 Month 
follow-up 
(+2 months) 
 
Informed Consent 
X 
 
 
 
 
 
 
 
 
 
Demographics 
X 
 
 
 
 
 
 
 
 
 
Medical and Surgical 
History 
X 
X 
 
 
 
 
 
 
 
 
Targeted Physical Exam 
X 
 
 
 
 
 
 
 
 
 
Height / Weight 2 
X 
 
 
 
 
 
 
 
 
 
Blood Collection, if 
required3 
X 
 
 
 
 
 
 
 
 
 
4-Point Monofilament 
Test, if required 4 
X 
 
 
 
 
 
 
 
 
 
Radiographic Imaging5 
X 
 
 
 
X 
X 
X 
X 
X 
 
VAS Pain Scale 
X 
 
X 
X 
X 
X 
X 
X 
X 
 
POSAS 
 
 
 
 
 
X 
X 
X 
X 
 
QOL Measurements6 
X 
 
 
 
 
 
X 
X 
X 
 
Medications Review 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
Digital Photos of Foot 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
Clinical Exam of Foot 
X 
 
X 
X 
X 
X 
X 
X 
X 
 
Foot Measurements 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
Pregnancy Test (if 
applicable) 7 
X 
 
 
 
 
 
 
 
 
 
Inclusion/Exclusion 
Criteria 
X8 
X9, 10 
 
 
 
 
 
 
 
 
Index Procedure 
 
X 
 
 
 
 
 
 
 
 
Wound check/surgical 
site healing 
 
 
X 
X 
X 
X 
 
 
 
 
Return to Weight-
Bearing Activities11 
 
 
X 
X 
X 
X 
X 
 
 
 
Range of Motion12 
X 
 
 
 
 
X 
X 
X 
X 
 
Secondary Surgical 
Interventions13 
 
 
X 
X 
X 
X 
X 
X 
X 
 
Adverse Events 
Assessment14 
 
X 
X 
X 
X 
X 
X 
X 
X 
 
Radiographic 
Measurements15 
X 
 
 
 
X 
X 
X 
X 
X 
 
Health Economic 
Outcomes16 
 
 
X 
X 
X 
X 
X 
X 
X 
 
General Satisfaction 
Questionnaire 
 
 
 
 
 
 
 
 
X 
 
Study Exit 
 
 
 
 
 
 
 
 
 
X  
 
 
 
 
 
 
 

 
 
 
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1 Baseline visit study activities must occur within 90 days of the Index Procedure unless otherwise noted. 
2 BMI should be calculated from height and weight measurement to determine patient eligibility.  
3 Blood collection is required only if subject has diagnosis of diabetes to determine fasting plasma glucose levels or 
HbA1c. 
4 4-point monofilament test is required only if subject has diagnosis of diabetes or if warranted by PI to assess for 
peripheral neuropathy. 
5 Three radiographic views of the operative foot should be obtained per visit (weight-bearing AP, lateral and axial 
views of operative foot).  The axial view should be collected using the study provided axial positioner.  
6 QOL assessment tools – MOxFQ and PROMIS-29 (PROMIS-25 for ages 14-17).  
7 Pregnancy test, if applicable, completed within 7 days of Index Procedure. May be completed on day of Index 
Procedure.  
 8 For the purposes of determining IMA, HVA and MAA for patient eligibility, measurements will be made 
according to institutional SOC.  For the purposes of all data analysis, measurements made by the Central Radiologist 
will be utilized.  If there are minor differences in baseline IMA, HVA and MMA measurements made by the central 
radiologist, the measurements of the PI/site will remain acceptable for determining patient eligibility. 
9 Confirm exclusion criterion “patient is not a current nicotine user” prior to start of anesthesia.  If subject indicates 
current use of nicotine, patient should be considered a screen failure.  
10 If subject requires an incision >4.0 cm to complete the Lapiplasty® Procedure, the subject should be considered a 
screen failure.  
11Documentation for return to weight bearing activities include time to start weight-bearing in boot, time to start 
weight-bearing in shoe, and time to full unrestricted activity. 
12ROM - dorsiflexion and plantarflexion should be measured while subject is passive and non-weightbearing with 
the study provided goniometer. 
13Secondary surgical interventions, Wound healing requiring intervention, infection requiring intervention, hardware 
removal, revision procedure of 1st ray, other complication requiring surgical intervention.   
14Only AEs related to the Lapiplasty® Index Procedure or the Lapiplasty® System Implants will be recorded on the 
eCRF.   
15Radiographic Measurements are completed by the Central Radiologist only. 
16Health Economic Outcomes, see Secondary Endpoints for data to be recorded on eCRF.  

 
 
 
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ETHICS 
Institutional Review Board 
The study will be conducted in accordance with the ethical principles that have their origins in the 
Declaration of Helsinki. 
 
The study protocol, any protocol amendments, Informed Consent Form (ICF), any ICF amendments, and 
if applicable, any other written information provided to the subjects e.g., subject recruitment advertising, 
will be reviewed and approved by an Institutional Review Board (IRB) prior to implementation of any 
procedures required solely for the purposes of this study.  Each Investigator must obtain IRB approval 
prior to consent of the first subject. 
 
Prior to site initiation, a signed copy of the IRB approval letter identifying the study and site is required to 
be submitted to the sponsor signifying study approval. 
 
Each Investigator must also maintain continuous IRB approval.  Documentation of approval and renewals 
must be provided to the Sponsor and filed on site in the Investigator’s Regulatory Binder.  Additionally, 
amendments to the protocol will be submitted for review before implementation except when necessary to 
eliminate apparent immediate hazards to a subject.  IRB approval is required to implement protocol 
amendments or to resume a suspended clinical investigation. 
 
The occurrence of serious or unanticipated Adverse Events (AEs) during the study must be reported to the 
IRB as required by local or central IRB procedures. 
 
Applicable Regulations 
Regulations are to be followed as applicable including: 21 CFR Parts 11 (Electronic Records; Electronic 
Signatures), 50 (Protection of Human Subjects), 56 (Institutional Review Boards), and 803 (Medical 
Device Reporting). All surgical products used in this study are commercially available and will be used 
within current labeling and indications for use.  Consequently, this study is not investigational and is 
exempt from 21CFR Part 54 (Financial Disclosure by Clinical Investigators) and 21CFR Part 812 
(Investigational Device Exemptions) with the exception of 21CFR812.119 (Disqualification of a Clinical 
Investigator); International Conference on Harmonization (ICH) Guideline E6 for Good Clinical Practice 
(GCP); Declaration of Helsinki; Health Insurance Portability and Accountability Act (HIPAA) 
regulations; and Applicable state and local laws and regulations. 
 
Subject Information and Consent 
This informed consent process applies to participation in the study only (i.e., this process does not include 
consent required for any protocol allowed concurrent procedures).  The surgeon will obtain the 
Institution’s standard informed consent for surgery, which includes the Lapiplasty® Procedure.   
 
In compliance with FDA regulations, no subject shall be enrolled in an investigation without provision of 
adequate informed consent.  The Principal Investigator is responsible for ensuring that each subject 
enrolled in the study is given adequate informed consent.  Failure to obtain and properly document this 
process is in violation of the US Code of Federal Regulations, the Declaration of Helsinki, and this study 
protocol. 
 

 
 
 
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The ICF must have the approval of the IRB.  While some institutions may request modification of the ICF 
to satisfy specific institutional requirements, the use of a modified or unique ICF is permitted if it meets 
the requirement of 21 CFR Part 50 and is approved by the Sponsor.  Informed consent of all subjects must 
be documented on an ICF in the primary language of the subject.  All translated consent forms need IRB 
approval.  Eligible U.S. subjects should also sign the Health Insurance Portability & Accountability Act 
form, if not combined with the ICF. 
 
The Investigator or designee shall carry out the Informed Consent process on those subjects meeting the 
eligibility criteria.  The informed consent process involves the following: giving a subject adequate 
information concerning the study, providing adequate opportunity (time) for the subject to consider all 
available options, responding to the subject’s questions, ensuring that the subject has comprehended this 
information and finally, obtaining the subject’s consent to participate in this study.  All subjects in this 
study should be completely informed about the purpose, risks, benefits, and other pertinent details of this 
study.  The informed consent process is careful to avoid the perception of any coercion or undue influence 
on, or inducement of, the subject to participate, and does not waive or appear to waive the subject's legal 
rights.  The ICF is presented in native, non-technical language that is understandable to the subject.  The 
ICF ensures important new information is provided to new and existing subjects throughout the clinical 
investigation.  
 
The Informed Consent process is finalized by completion of the ICF.  Following the explanation of the 
study intent, the Investigator or designee shall offer to answer any of the subject’s questions.  If the 
subject then agrees to participate, his or her willingness must be documented via signatures of the ICF. 
 
This document must be signed and dated by the subject prior to any study related procedures or 
enrollment.  No dates should be pre-populated or completed by someone other than the person providing 
the signature.  The subject will be provided with a copy of the signed informed consent document. 
 
During a subject's participation in the study, the subject will sign and date any amendment(s) to the 
informed consent document and a copy of the signed document will be provided to them. 
 

 
 
 
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STUDY ADMINISTRATIVE STRUCTURE 
This study is sponsored by Treace Medical Concepts, Inc. and will be conducted in the US, under a single 
protocol approved by an IRB for each site prior to implementation at the study site.   
 
The Principal Investigators (PI) at the study sites are required to be either a DPM or MD/DO qualified by 
education, experience and training to assume responsibility for the conduct of this study.  Individual 
centers and investigators are selected based on their prior experience with the Lapiplasty® Procedure and 
use of the Lapiplasty® Mini-Incision™ System.  
 
An Electronic Data Capture (EDC) system will be utilized by study site personnel to transfer study data 
from source records (medical records and/or source document worksheets) onto common electronic case 
report forms (eCRFs). The EDC system is a web-based, secure electronic software and is compliant with 
national and international GCP data protection/data privacy and electronic record/electronic signature 
(e.g., 21 CFR Part 11) regulatory requirements. 
 
Serious Adverse Events (SAEs) and product quality problems (for products used during the index 
procedure), including potential and actual product use errors suspected to be associated with the use of a 
Food and Drug Administration (FDA) regulated drug, biologic, medical device or dietary supplement 
used during the course of this study will be reported by the PI to applicable authorities including the: 1) 
Sponsor (TMC); 2) IRB; 3) respective manufacturer(s); and/or 4) FDA via MedWatch Online Voluntary 
Reporting Process or Medical Device Reporting (MDR) as appropriate. 
1.0 INTRODUCTION 
Though the majority of hallux valgus (or “bunion”) surgeries today are performed via a two-dimensional 
(2D) metatarsal osteotomy approach in which the metatarsal bone is cut and shifted over, this surgical 
approach has demonstrated unacceptably high long-term recurrence rates of up to 30-78%.1,2 Recent 
research demonstrates that 87% of bunions3 actually have three-dimensional (3D) deformities with 
abnormal frontal-plane rotation of the metatarsal bone, which cannot be addressed with a 2D metatarsal 
osteotomy.  Correction of metatarsal rotation is critical for restoration of normal anatomic alignment, 
which left unaddressed, is associated with a 10.0-12.7 times likelihood of radiographic recurrence.4,5  The 
Lapiplasty® Procedure (which was awarded a US patent on the surgical method) is a commercially 
available system that allows the surgeon to correct the bunion deformity at its apex and in all 3 anatomic 
planes (3D correction), including frontal-plane metatarsal rotation. 
Correction at the 1st tarsometatarsal joint, also known as Lapidus fusion, provides the optimal surgical 
approach for true 3D anatomic restoration of the entire metatarsal bone, at the apex of the bunion 
deformity.  However, the conventional Lapidus fusion technique has traditionally been a technically 
challenging procedure with high variability, requiring 6-8 weeks non-weightbearing, and furthermore 
does not directly address frontal-plane metatarsal rotation.  The patented Lapiplasty® Procedure is 
designed to allow the surgeon to perform a Lapidus fusion in a much more controlled and reproducible 
manner, while also correcting frontal-plane rotation of the metatarsal (i.e., 3D correction) and returning 
the patient to weight-bearing typically in less than 2 weeks.6   
 

 
 
 
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A recent multicenter, retrospective study demonstrated the benefits of the Lapiplasty® Procedure.  In the 
study, 72 hallux valgus patients (61 feet meeting 1-year endpoint) were treated with the Lapiplasty® 
Procedure with an early return to weight-bearing (average 10.5 days post-op).  At average follow-up of 
13.5 months, the results demonstrated 96.7% of patients maintained their 3-plane correction 
(intermetatarsal angle, hallux valgus angle, and tibial sesamoid position), and only 1.6% experienced a 
symptomatic nonunion complication7. 
In this study, we will evaluate the outcomes of patients in need of hallux valgus surgery that undergo the 
Lapiplasty® Procedure using the Lapiplasty® Mini-Incision™ System.  The Lapiplasty® Mini-
Incision™ System is designed to deliver the same patented Lapiplasty® Procedure providing 3-plane 
correction through a 3.5cm dorsal incision.   
 
2.0 STUDY OBJECTIVES  
 
The objectives of this study are to evaluate outcomes of the Lapiplasty® Procedure using the Lapiplasty® 
Mini-Incision™ System for patients in need of hallux valgus surgery:  
1. To determine radiographic recurrence of hallux valgus and the timing of failure following 
hallux valgus correction with the Lapiplasty® Procedure. 
2. To determine whether the Lapiplasty® Procedure effectively corrects anatomical alignment 
of the 1st metatarsal and sesamoids in all three planes. 
3. To assess whether early weight-bearing after the Lapiplasty® Procedure affects the union 
rates or causes loss of 3-plane correction. 
4. To evaluate the quality of life and pain scores following the Lapiplasty® Procedure.  
3.0 STUDY ENDPOINTS 
 
Primary:  
Radiographic recurrence of hallux valgus deformity at 24 months for subjects with successful correction 
(defined as IMA <9.0°, HVA<15.0° and TSP as ≤ 3 at 6 weeks post-Lapiplasty® Procedure). Recurrence 
is defined by any two of the following three criteria being met at 24 months post-procedure: IMA of ≥12°, 
HVA ≥20° and TSP ≥4. 
Secondary: 
1. Change in radiographic angular/positional alignment before and after the Lapiplasty® Procedure 
[Time Frame: pre-operatively, 6 weeks, 4 months, 6 months, 12 months, and 24 months, post-
Lapiplasty® Procedure].   
2. Evaluate clinical/radiographic healing (union vs non-union). Non-union defined as lucency at 
TMT joint, hardware failure and/or loss of correction (recurrence), plus clinical pain at first TMT 
joint at 12 months post- Lapiplasty® Procedure. 
3. Clinical complications through 24-month follow-up visit due to the Lapiplasty® System 
Implants, the Lapiplasty® Procedure, the post-operative weight-bearing protocol or health 
conditions that could affect other outcome measures. 
4. Time to start weight-bearing in a boot, in days. 
5. Time to start weight-bearing in shoes, in days. 

 
 
 
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6. Time to return to full unrestricted activity, in days. 
7. Change in pain at the base of the big toe (bunion related) assessed via a Visual Analog Scale 
(VAS) at 0-14 days, 14-21 days, 6 weeks, 4 months, 6 months, 12 months and 24 months post-
Lapiplasty® Procedure, in comparison to baseline visit pain.   
8. Change in Quality of Life, (PROMIS-29, PROMIS-25 and MOxFQ) defined as the total score 
measured at 6 months, 12 months and 24 months post-Lapiplasty® Procedure, in comparison to 
baseline visit.  
9. Change in Range of Motion - 1st MTP dorsiflexion and plantarflexion at 12 months and 24 
months post-Lapiplasty® Procedure, in comparison to baseline visit.  
10. Change, if any, in initial incision length during Lapiplasty® Procedure.  
11. Change in radiographic foot length and width at 12 months post-Lapiplasty® Procedure in 
comparison to baseline visit.   
12. Change in swelling at 6 weeks and 4 months post-Lapiplasty® Procedure as compared to 0-2 
week visit.   
13. Change in scar quality at 4 months, 6 months, and 12 months post-Lapiplasty® Procedure in 
comparison to baseline visit.  
14. Correlation between amount of time external positioner is actively used during Lapiplasty 
Procedure with necrosis, blistering, bruising and tissue ulceration events.   
Secondary Endpoints – Health Economic Outcomes  
All health economic endpoints are exploratory in nature. 
1. Complications below that are related to the Lapiplasty® Procedure or the Lapiplasty® System 
Implants requiring subsequent secondary surgical interventions, defined as the following: 1) 
deviations/delay from normal operative plan 2) readmission to hospital 3) return to operating 
room 4) unscheduled visits due to complications 5) employment of home health services; 
a. Revisions 
b. Hardware removals 
c. Reoperations 
d. Supplemental fixations 
e. Wound healing requiring surgical intervention 
f. Infection at surgical site requiring surgical intervention  
2. Time to return to work (or normal household activities if non-working), in days, while noting 
work status and work classification (sedentary, light work, medium work, heavy work, very 
heavy work). 
3. Time to return to full work, in days (or full household activities if non-working), while noting 
work status and work classification (sedentary, light work, medium work, heavy work, very 
heavy work). 
4. Post-operative physical therapy requirements required for recovery of the Lapiplasty® Procedure. 

 
 
 
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4.0 INVESTIGATIONAL PLAN 
 
4.1 
Overall Study and Design – Subject Disposition Diagram 
 
 
Subject Consented/ 
Enrolled
Subject Screening
Inclusion/Exclusion
Index Procedure/ 
Subject Treated  
Subject Follow-Up
Study Exit
Screen Failure 
Early Term 

 
 
 
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Overall Study and Design – Description 
Patients 14 years through 58 years with symptomatic hallux valgus will be eligible to participate based on 
the inclusion and exclusion criteria defined in this protocol. 
 
The overall plan for all subjects consists of the following elements: 
• 
Patients will be informed about the nature of the research, given the ICF to read, and if the patient 
understands and agrees to the procedure, they will be asked to provide written informed consent. 
Subjects are considered enrolled in the study when they have signed an informed consent; 
• 
Subjects will undergo screening procedures during the baseline visit to determine if inclusion and 
exclusion criteria are satisfied and the subject is eligible for the study procedure; 
• 
Subjects must meet all inclusion/exclusion criteria before being treated in the study.  If any 
eligibility criteria (including intra-operative criteria) are not satisfied, the subject will be 
considered a screen failure and will not be considered treated in the study; 
• 
Subjects will undergo the Lapiplasty® Procedure, per protocol.  Subjects are considered treated 
in the study when biplanar plating at the TMT joint is complete and the incision length is 
confirmed to meet criteria;   
• 
Subjects will be followed for up to 2 years post index procedure to evaluate outcomes and 
potential complications; 
• 
Subjects will be assessed for AEs and will be instructed to notify the PI of any AEs that occur 
during the entire course of the study.  Data will be recorded into subject source medical records.    
4.2 
Selection of Study Population 
4.2.1 
Recruitment 
All patients who meet the inclusion criteria will be tracked on a Screening Log.  Patients who meet 
inclusion criteria will be provided with the IRB approved ICF and will have the opportunity to read, 
understand, and have their questions answered prior to signing the ICF.  If the patient agrees to participate 
in the study and signs consent, the ICF will be completed.  The subject must sign and date the ICF prior to 
any study-specific procedures being performed.  The person reviewing the ICF with the subject will also 
sign and date the ICF.  The subject will be given a copy of the signed ICF to keep. 
All subjects who sign the ICF will be documented on a paper Screening and Enrollment Log. All subjects 
who sign the ICF will be entered in the EDC. 
Upon entering subject enrollment information into the EDC, each subject will be assigned a unique ID 
number sequentially in ascending order.   
4.2.2 
Enrollment and Treatment 
• 
Subjects are considered enrolled in the study once the informed consent has been signed by the 
patient.  Subjects who sign a consent document, but do not meet inclusion/exclusion criteria 
(including intra-operative criteria) will be considered a screen failure.  Subjects are considered 
treated in the study when the biplanar plating is complete and the incision length is confirmed to 
meet criteria.  

 
 
 
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4.2.3 
Inclusion Criteria 
Patients satisfying the following criteria will be considered the screening population and will be eligible 
for participation: 
1. Male and females between the ages 14 and 58 years at the time of consent; 
2. Closed physeal plates at the time of consent; 
3. Intermetatarsal angle is between 10.0˚ - 22.0˚; 
4. Hallux valgus angle is between 16.0˚ - 40.0˚; 
5. Willing and able to adhere to early weight-bearing instructions post-operatively; 
6. Capable of completing self-administered questionnaires; 
7. Acceptable surgical candidate, including use of general anesthesia; 
8. Female patients must be of non-childbearing potential or have a negative pregnancy test within 7 
days prior to index procedure; 
9. Willing and able to schedule index procedure within 3 months of consent and able to return for 
scheduled follow-up visits; 
10. Willing and able to provide written informed consent. 
4.2.4 
Exclusion Criteria 
Patients satisfying the following criteria will not be eligible for participation: 
1. Previous surgery for hallux valgus on operative side; 
2. Previous surgeries on operative foot involving fusion of foot or ankle joints (other than 
hammertoe or lesser toes/digits); 
3. Additional concomitant procedures outside of the 1st ray; 
4. Moderate or Severe osteoarthritis of the MTP joint based on radiographic imaging (including lack 
of evident crista) or positive grind test; 
5. Symptomatic flatfoot or asymptomatic flatfoot (defined as calcaneal inclination <5˚and 
talonavicular subluxation/uncovering >50%); 
6. BMI >40 kg/m²; 
7. Current nicotine user, including current use of nicotine patch; 
8. Current clinical diagnosis of diabetes with fasting plasma glucose > 126 mg/dL and/or 
HbA1c ≥7.0; 
9. Current clinical diagnosis of peripheral neuropathy or by assessment on 4-point monofilament 
test; 
10. Current clinical diagnosis of fibromyalgia; 
11. Current clinical diagnosis of Complex Regional Pain Syndrome/Reflex Sympathetic Dystrophy 
(CRPS/RSD); 
12. Current uncontrolled hypothyroidism; 
13. Previously sensitized to titanium; 
14. Currently taking oral steroids or rheumatoid biologics; 

 
 
 
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15. Currently taking immunosuppressant drugs; 
16. Insufficient quantity or quality of bone to permit stabilization, conditions that retard healing (not 
including pathological fractures) and conditions causing poor blood supply such as peripheral 
vascular disease; 
17. Active, suspected or latent infection in the affected area; 
18. Use of synthetic or allogenic bone graft substitutes; 
19. Current diagnosis of metatarsus adductus (defined as MAA ≥ 23˚);  
20. Known keloid and hypertrophic scar forming; 
21. Scheduled to undergo a same-day bilateral procedure.  Patient agrees to refrain from the 
Lapiplasty® Procedure (or other hallux valgus procedures) on contralateral foot for minimum of 6 
months post index procedure; 
22. Patient has previously been enrolled into this study for a contralateral procedure; 
23. Scheduled for any concomitant procedure that would alter patient’s ability to early weight-bear 
post-procedure; 
24. Patient requires an incision >4.0 cm to complete the procedure (determined pre-operatively or 
intra-operatively); 
25. Patient is actively involved with a workman's compensation case or is currently involved in 
litigation; 
26. Patient is currently or has participated in a clinical study in the last 30 days prior to signing 
informed consent or is considering participation in another research protocol during this study.  
Exceptions to this include survey clinical studies with no treatment or if subject is greater than 12 
months post procedure in the Treace ALIGN3D™ study without ongoing protocol defined AE; 
these are not exclusionary; 
27. Patient has a condition or finding that, in the opinion of the Investigator, may jeopardize the 
patient’s well-being, the soundness of this clinical study, or could interfere with provision of 
informed consent, completion of tests, therapy, or follow-up. 
4.2.5 
Removal of Subjects from Study 
In accordance with the Declaration of Helsinki and the Code of Federal Regulations, a subject has the 
right to withdraw from the study at any time for any reason without prejudice to his/her future medical 
care by the physician or the institution.  Should a subject (or subject’s legally authorized 
guardian/representative) decide to withdraw, all efforts will be made to collect and report the final visit 
observations as thoroughly and timely as possible.   
The primary reason for early termination and the date of termination will be recorded in the electronic 
case report form.  Reasons may include: 
Investigator Decision 
If the subject experiences an adverse event or the Principal Investigator or Medical Monitor 
believes it is in their best interest to discontinue participation in the study for other reasons, they 

 
 
 
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will be withdrawn from the study. 
Lost to Follow-up 
When contact with the subject has been lost without completing the final visit assessment, and 
every attempt to contact has failed, the subject will be considered lost to follow-up.  Final 
documentation regarding all attempts to contact the subject requesting their return for the final 
visit should be documented. 
Withdrawal of Consent 
The subject withdraws consent for participation in the study.  Any method of contact with the 
subject in which they state they no longer want to participate in the study specific activities 
constitutes withdrawal of consent.  When possible the reason for withdrawal will be documented. 
Site Termination or Study Termination 
A site or study may be terminated.  When this occurs all subjects at the site will be withdrawn and 
documented as early termination.  Reasons for site or study termination may include, but are not 
limited to the following: 
• 
Administrative Concerns (e.g., inadequate subject enrollment, Investigator/institution non-
compliance, change of business strategy, etc.); 
• 
Safety Issues, including those due to non-compliance, which substantially affect the risk to 
benefit ratio of the study subjects at a site or for the study as a whole; 
• 
Regulatory Body Mandate(s). 
 
Other (which may include): 
• 
Protocol deviation, noncompliance or violation; 
• 
Sponsor recommendation; 
• 
Device/index procedure failure, including subjects who had a previously unidentified 
medical history finding that made treatment with the Lapiplasty® Mini-Incision™ System 
unfeasible;  
• 
Death. 
5.0 PROCEDURE 
5.1 
General Description 
Individual centers and investigators will be selected based on their expertise and proficiency in the 
Lapiplasty® Procedure utilizing the Lapiplasty® Mini-Incision™ System.   
The term index procedure refers only to the use of the Lapiplasty® Mini-Incision™ System during the 
Lapiplasty® Procedure. All concomitant procedures leading up to and after the Lapiplasty® Procedure 
and use of any TMC devices are considered concurrent procedures and are to be conducted under the 
discretion of the surgeon in accordance to the hospital’s standard of care. 
Note: A recommended procedure is presented below. It is recognized that individual patient anatomic 
variation, surgical conditions, or surgeon preference may necessitate modifications to the outlined 

 
 
 
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procedures.  Regardless, surgeons must adhere to all TMC device’s instructions for use as outlined in the 
IFU. The Lapiplasty® Mini-Incision™ System will only be used by properly trained and qualified 
medical personnel in accordance with the Instructions for Use (IFU).  Failure to properly follow 
instructions may result in improper functioning of the device(s). No non-Treace products are to be used 
for the procedures, unless deemed medically necessary by the PI.  
5.2 
Lapiplasty® Procedure (Mini-Incision™ Approach)  (Index Procedure)  
5.2.1 
Key Surgical Steps  
 
Mini Dorsal Incision 
Make a direct dorsal, 3.5cm (approximate) incision and release the 1st TMT joint with a sagittal saw and 
osteotome. 
 
Triplanar Correction 
Insert SpeedSeeker™ Instrument and apply Mini-Incision™ Positioner over the skin of 1st metatarsal to 
perform 3-plane correction. 
 
Precision Cuts 
Secure the Mini-Incision™ Cut Guide on the SpeedSeeker™ and make precision joint cuts with the 
correction held in place.  
 
Controlled Compression 
Apply the Lapiplasty® Compressor to bring the precision-cut joint surfaces together for controlled 
apposition of the arthrodesis site.  
 
Plate Application 
Utilize the Lapiplasty® Plate Holder to apply the locking plates dorsally and medially, securely 
positioning the PlantarPower™ Plate across the tension side of the joint.  
 
Multiplanar Fixation 
Low-profile Lapiplasty® Biplanar Plating is designed to provide multiplanar stability.  
 
5.3 
Post Index Procedure – Post-Operative Care and Weight-Bearing Instructions 
The appropriate post-operative care and the timing to return the subject to weight-bearing is at the 
discretion of the Investigator/Institutional SOC and takes into consideration the subject’s ability to safely 
begin weight-bearing.   However, for purposes of this study, subjects should be bearing weight in a CAM 
boot by 3 weeks post-operatively.  Below is a recommended approach for a patient’s post-operative care. 
 
• 
Subject may be either bandaged, put in splint/cast or put in boot at the time of surgery.  If subject 
is fitted with CAM boot at discharge, the subject should be provided instructions on how to begin 
protected weight-bearing (see bullet 5).  The type of post-operative surgical protection utilized 
will be recorded on the eCRF.  If subject is allowed to begin protected weight-bearing (in boot) at 

 
 
 
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discharge, the date that the subject is allowed to start weight-bearing in the boot will be recorded 
on the eCRF. 
• 
Subject is instructed to remain off the operative foot as much as possible for the first few days 
post-op. This is to limit bleeding and swelling and to allow soft tissues to recover.   
• 
Subject leaves the surgery facility with crutches, walker, rolling knee scooter or wheelchair.  The 
type of post-operative mobility aid utilized will be recorded on the eCRF.  
• 
At the first post-op visit (00-14 days), bandages are removed, and the subject can be allowed to 
shower.  Subject may wear an athletic sock.  No bandages or splints are needed.  The subject 
should be reminded of post-op care of the foot/surgical site.  
• 
At the first or second post-op visit (0-14 days or 14-21 days), if the subject has not already been 
fitted for a CAM boot at discharge, the subject is fitted with a CAM boot (low or high). Subject 
should be provided with instructions on how to begin protected weight-bearing in the CAM boot 
and acceptable activities:  
o Subject is instructed to put weight on foot as tolerate in the restrictive boot. 
o Subject is instructed not to roll forward onto the big toe and should remain on flat foot.  
o Subject is instructed to remove the CAM boot multiple times daily and perform range of 
motion exercises for ankle and foot. 
NOTE: The subject must be fitted with a CAM boot and allowed to start protected weight-
bearing no later than 3 weeks post-operatively.   The date that the subject is allowed to start 
weight-bearing in the boot will be recorded on the eCRF.  
NOTE: If the subject is unable to start weight-bearing by 3 weeks, the reason for the 
delay in weight-bearing should be documented on the eCRF as a protocol deviation. The 
subject should be brought in for an Unscheduled Visit (See Section 7.10) when they are 
ready to begin protected weight-bearing in the boot.  
• 
At the first or second post-op visit (0-14 days or 14-21 days), compression socks may be provided 
to the patient. The start date and the stop date (approx. by the 4-month visit) of use of the 
compression sock will be recorded. 
• 
At the 6-week post-op visit, if the subject is clinically stable, patient can transition from the boot 
to a shoe (running or another athletic shoe).  The date that the subject is allowed to start to WB in 
a shoe will be recorded on the eCRF. The transition from boot to shoe may occur over a period of 
days/weeks, depending on patient healing and tolerance.  Subject are instructed that they can walk 
normally but are not to stand on toes, run, jump or do any other high impact activity.   
• 
At the 4-month post-op visit, subjects are allowed to begin low impact exercise if they are 
clinically stable. The date that the subject is allowed to start full unrestricted activities (i.e., 
running and jumping) will be recorded on the eCRF. 
5.4 
Pain Management 
The decision to administer pain medication therapy in the pre- and post-operative/follow-up setting is at 
the discretion of the Investigator/Institution taking into consideration the subject’s ability to safely take 
pain medication therapy.   
It is recommended that a multi-modal pain regimen be considered which would include, but not be 
limited to: ice, elevation, local & regional anesthesia, NSAIDs, acetaminophen, neuro-modulation drugs 
and narcotics. 

 
 
 
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The decision of which pain medications to use (if any) is left to the discretion of the Investigator.  Pain 
medications taken for pain management during the pre- and post-operative/follow-up period will be 
recorded.  
6.0 IDENTITY OF STUDY DEVICES 
The devices utilized for the study include: 
Mini-Incision™ Precision Instrument Set 
Lapiplasty® Mini-Incision™ System   
 
The TMC Plating System is intended for use in stabilization of fresh fractures, revision procedures, joint 
fusion and reconstruction of small bones of the feet. The system can be used in both adult and pediatric 
patients aged >12 years.   
 
All medical devices used during this study are cleared for commercial distribution and are to be used in 
accordance with approved product labeling. 
 
Device Description  
The Lapiplasty® Mini-Incision™ Precision Instrument Set includes the SpeedSeeker™ Instrument, the 
Mini-Incision™ Positioner, the Mini-Incision™ Cut Guide and the Plate Holder.  These are reusable 
instruments and not unique to each patient.  The actual components in the instrument pack may vary by 
site.   
 
The Lapiplasty® Mini-Incision™  includes the  Mini-Incision™  Plate and the PlantarPower™  Plate and 
locking screws. The PlantarPower™  Plate is uniquely contoured to span plantarly across the tension-side 
of the 1st TMT joint, while providing easy access to each locking screw without the need for extensive 
retraction of the mini dorsal incision. (See Figure 1) 
 
Figure 1 
 
 

 
 
 
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6.1 
Product Accountability 
Commercially available devices will be utilized for the study subjects; therefore, product accountability 
and reconciliation records will not be required.  Devices will not be provided by the sponsor. Study 
devices and instruments that are used during each procedure will be documented on the eCRFs as listed in 
Visit 2. 
 
 
 

 
 
 
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7.0 SUBJECT VISITS 
Details for specific subject visit activities are found below and reflect the Schedule of Assessments table. 
7.1 
Visit 1 – Baseline 
Subjects will be screened for study participation during the baseline visit.  The procedures required for the 
baseline visit may be conducted during more than one visit.  Some baseline procedures may have been 
completed as patient standard of care (including radiographic imaging) and therefore may be completed 
prior to informed consent and do not need to be repeated after consent. 
The following procedures must be conducted within 90 days prior to the index procedure.   
• 
Informed Consent 
• 
Demographics [including foot size (length and width) of operative foot and work 
status/work classification] 
• 
Relevant Medical and Surgical History, including any previous history of foot surgery 
and any pre-planned surgical foot procedures  
• 
Targeted Physical Exam 
• 
Height / Weight (including BMI calculation) 
• 
Blood Collection – (fasting plasma glucose or HbA1c – only required if patient has 
current clinical diabetes diagnosis)  
• 
4-Point Monofilament Test (only required if patient has current clinical diabetes 
diagnosis or if suspicion of peripheral neuropathy based on medical history)  
• 
Clinical Examination of Operative Foot 
• 
Foot Measurements 
• 
Range of Motion 
• 
Radiographic Imaging 
o Weight-bearing AP, lateral and axial views of operative foot 
• 
Radiographic Measurements 
o Note: For the purposes of determining IMA, HVA and MAA for patient 
eligibility, measurements will be made according to institutional SOC.  For the 
purposes of all data analysis, measurements by the central radiologist will be 
utilized.  If there are minor differences in baseline IMA, HVA and MAA 
measurements made by the central radiologist, the measurements of the PI/site 
will remain acceptable for determining patient eligibility. 
• 
VAS Pain Scale  
• 
QOL Measurements 
• 
Digital photograph of operative foot, preferred but not required 
• 
Medications Review 
• 
Pregnancy Test (if female of childbearing potential) 
o Must be within 7 days of index procedure or may be completed on day of index 
procedure 
• 
Inclusion/Exclusion Criteria 

 
 
 
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7.2 
Visit 2 –Index Procedure  
The following must be conducted: 
• 
Exclusion Criteria (confirm patient has abstained from nicotine use prior to anesthesia) 
• 
Medical History [if relevant medical history (e.g., related to bone quality or patient 
condition that does not exclude them from participation in study) is identified during 
index procedure] 
• 
Foot Measurements  
• 
Index Procedure 
o Start and stop time of tourniquet placement 
o Time of first incision and placement of final plate screw 
o Length of incision at start of procedure 
o Extension of incision and location of extension (proximal, distal or both), as 
applicable   
o Completion of lateral release 
o Use of SpeedSeeker™ device (or fulcrum and joint seeker) 
o Total length of time of use of Mini-Incision™ Positioner  
o Use of Mini-Incision™ Cut guide  
o Joint morphology of articular surface (uni-facet, bi-facet, or tri-facet), if feasible 
o Use of Compressor device 
o Use of Mini-Incision™ System 
o Use of Transverse Screw and location of screw placement, if applicable 
o Use of Interfrag Screw at TMT joint, if applicable 
o Use of additional plate screws (Long Screw Pack, FastPitch™ Screw Pack, 
other), if applicable 
o Use of Headless Screw for Akin procedure, if applicable 
o Length of incision after suturing complete 
o If incision required extension beyond >4.0 cm to complete Index 
Procedure, the subject will be treated as a screen failure.   
• 
Digital photograph of operative foot, post-incision, not required 
• 
Post-op surgical dressing/protection utilized 
• 
Concomitant Procedures performed  
• 
Deviations/Delays to Normal Operative Plan 
• 
Medications Review (Pre-operative and Post-operative) 
• 
Adverse Events Assessment, including Intra-Operative Procedural Complications 
• 
Post-op Care instructions review 
o Post-op mobility assistance device utilized 
• 
Post-op Weight-Bearing protocol instructions review  
 
 
 

 
 
 
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7.3 
Visit 3 – 0-14 Day Follow-Up  
The following must be conducted: 
• 
Digital photograph of operative foot, not required 
• 
Clinical Exam of operative foot 
• 
Foot Measurements 
• 
Wound Assessment/healing of surgical site including damage by external positioner 
• 
VAS Pain Scale 
• 
Post Operative use of compression sock, if applicable 
• 
Return to Weight-Bearing Activities (CAM boot fitting, if not on day of surgery) 
• 
Secondary Surgical Interventions 
• 
Medications Review 
• 
Adverse Event Assessment 
• 
Health Economic Outcomes 
7.4 
Visit 4 – 14-21 Day Follow-Up (+ 3 days) 
The following must be conducted: 
• 
Digital photograph of operative foot, not required 
• 
Clinical Exam of operative foot 
• 
Foot Measurements 
• 
Wound Assessment/healing of surgical site including damage by external positioner 
• 
VAS Pain Scale 
• 
Post Operative use of compression sock, if applicable 
• 
Return to Weight-Bearing Activities (CAM boot fitting – if not at previous visit) 
• 
Secondary Surgical Interventions 
• 
Medications Review 
• 
Adverse Event Assessment 
• 
Health Economic Outcomes 
7.5 
Visit 5 – 6 Week Follow-Up (± 2 weeks) 
The following must be conducted: 
• 
Digital photograph of operative foot, not required 
• 
Radiographic Imaging (axial view may be missed if patient is unable to use positioning 
block due to post-operative range of motion limitations) 
• 
Clinical Exam of operative foot 
• 
Foot Measurements 
• 
Wound assessment/healing of surgical site including damage by external positioner 
• 
VAS Pain Scale 
• 
Post Operative use of compression sock, if applicable 

 
 
 
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• 
Return to Weight-Bearing Activities  
• 
Secondary Surgical Interventions 
• 
Medications Review 
• 
Adverse Event Assessment 
• 
Health Economic Outcomes 
• 
Radiographic Measurements  
7.6 
Visit 6 – 4 Month Follow-Up (± 2 weeks) 
The following must be conducted: 
• 
Digital photograph of operative foot, not required 
• 
Radiographic Imaging 
• 
Clinical Exam of operative foot 
• 
Foot Measurements 
• 
Wound assessment/healing of surgical site including damage by external positioner 
• 
VAS Pain Scale 
• 
Post Operative use of compression sock, if applicable 
• 
POSAS 
• 
Range of Motion 
• 
Return to Weight-Bearing Activities 
• 
Secondary Surgical Interventions 
• 
Medications Review 
• 
Adverse Event Assessment 
• 
Health Economic Outcomes 
• 
Radiographic Measurements  
7.7 
Visit 7 – 6 Month Follow-Up (± 1 month) 
The following must be conducted: 
• 
Digital photograph of operative foot, not required 
• 
Radiographic Imaging 
• 
Clinical Exam of Operative Foot 
• 
Foot Measurements 
• 
POSAS 
• 
QOL Measurements 
• 
VAS Pain Scale 
• 
Range of Motion 
• 
Return to Weight-Bearing Activities 
• 
Secondary Surgical Interventions 
• 
Medications Review 

 
 
 
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• 
Adverse Event Assessment 
• 
Health Economic Outcomes 
• 
Radiographic Measurements  
7.8 
Visit 8 - 12 Month Follow-Up (± 1 month) 
The following must be conducted: 
• 
Digital photograph of operative foot, not required 
• 
Radiographic Imaging  
• 
Clinical Exam of Operative Foot, including Clinical Pain Assessment at 1st TMT Joint 
• 
Foot Measurements 
• 
POSAS 
• 
QOL Measurements  
• 
VAS Pain Scale 
• 
Range of Motion 
• 
Secondary Surgical Interventions 
• 
Medications Review 
• 
Adverse Event Assessment 
• 
Health Economic Outcomes 
• 
Radiographic Measurements  
7.9 
Visit 9 – 24 Month Follow-Up (± 2 months) 
The following must be conducted: 
• 
Digital photograph of operative foot, not required 
• 
Radiographic Imaging 
• 
Clinical Exam of Operative Foot, including Clinical Pain Assessment at 1st TMT Joint 
• 
POSAS  
• 
QOL Measurements  
• 
VAS Pain Scale 
• 
Range of Motion 
• 
General Satisfaction Questionnaire (Appendix 10) 
• 
Secondary Surgical Interventions 
• 
Medications Review 
• 
Adverse Event Assessment 
• 
Health Economic Outcomes 
• 
Radiographic Measurements  
  
 
 
 

 
 
 
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7.10 
Unscheduled Visit 
If a subject requires an unscheduled visit due to a complication associated with the Lapiplasty® 
Procedure or Lapiplasty® device, for suspected non-union or for additional follow-up on start of WB 
activities, the following should be conducted: 
• 
Reason for Visit (complication/adverse event, suspected non-union or WB instructions) 
• 
Clinical Exam of Operative Foot 
• 
Return to WB Activities, if applicable 
• 
Adverse Event Assessment 
• 
Radiographic Imaging (if required due for assessment of complication)  
7.11 
Study Exit 
At study exit the following must be collected. 
• 
Study Exit Date 
• 
Exit Reason 
7.12 
Study Visit Descriptions 
All study procedures should be conducted at the investigational site.   
Demographics – Date of birth (age), sex, race, ethnicity, foot size (length and width) and work status 
including work classification (sedentary, light work, medium work, heavy work, very heavy work – see 
Appendix 1 for definitions).   Foot size measurements must be done with study provide tool.  
Relevant Medical and Surgical History – Medical history includes, but is not limited to, relevant 
comorbidities (documentation of nicotine use status, any immunosuppressive disease, any endocrine 
disease, diabetes, osteoporosis, hypertension, cerebrovascular disease, chronic kidney disease, depression, 
rheumatoid arthritis, psoriatic arthritis, fibromyalgia, and peripheral neuropathy).  Any relevant medical 
conditions that are identified during the index procedure, which were not identified during the baseline 
visit, should be recorded as medical history (not as an adverse event or surgical complication).  
Relevant surgical history includes, but is not limited to, previous operative foot surgery (including a 
previous Lapiplasty procedure on opposing study foot).  Any planned surgical interventions should also 
be recorded.  
Targeted Physical Examination:  A targeted physical exam (PE) will be conducted according to 
institutional SOC.  If any findings are noted during the PE, the finding should be recorded in the source 
documents as medical history, as appropriate.   
Height/Weight – will be collected according to institutional SOC.  BMI should be calculated to 
determine if the patient is eligible to participate in the study.  
Medication Review:  All medications, including vitamins or nutritional supplements currently prescribed 
to, or taken by, the subject shall be recorded in the subject’s source documents.  If Vitamin D is taken by 
the subject, it must be recorded on the eCRFs.  Anti-inflammatory medications/medications that affect 

 
 
 
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swelling, medications taken as part of the multi-modal pain therapy or medications taken for pain related 
to surgery, or bunion/foot pain or medications for complications due to procedure (e.g. antibiotics for a 
surgical site infection) also must be recorded on the eCRFs. 
Blood Collection – HgbA1c or fasting plasma glucose must be measured only for any patient that has a 
clinical diagnosis of diabetes, prior to confirming the patient is eligible to participate in the study. 
4-Point Monofilament Test – Test must be conducted per institutional SOC for any patient that has a 
clinical diagnosis of diabetes, prior to confirming the patient is eligible to participate in the study.   
Radiographic Imaging – Image collection will be conducted per institutional SOC but must include the 
following views at each timepoint: weight-bearing AP, lateral and axial (6-week follow-up axial view 
optional).  A positioning block will be provided and must be utilized for the axial view.  A radiographic 
imaging protocol will be provided for instructions on collection and transmission of the radiographs for 
the radiographic measurements.   
VAS Pain Scale – See Appendix 2. The subject should be requested to read the Mankoski Pain Scale 
Definitions prior to completing the scale.  The subject should be instructed to rate pain associated with the 
base of the big toe (bunion related) for the operative foot only. 
QOL Measurements:  See Appendix 3.  The MOxFQ and PROMIS-29 (PROMIS-25 for ages 14-17) 
will be collected per the questionnaire instructions. The same version of the PROMIS (25 or 29) 
questionnaire completed at baseline on a subject must be used for all follow-up visits for comparability of 
results.  
Wound Assessment/Healing of surgical site: – Evaluation of all incision site(s) to assess for wound 
healing/surgical site healing.  Normal/expected pain, swelling, redness, etc. does not require 
documentation as an adverse event. However, infections or wound healing complications requiring 
treatment/intervention or pain, swelling, redness, etc. that is considered substantially worse than 
anticipated should be recorded as an AE.  In addition, damage caused specifically by the external 
positioner must be documented in eCRF.  Potential complications due to external positioner may include, 
but not be limited to, necrosis, bruising, blistering, and/or tissue ulceration. If complications occur, they 
should be recorded as Adverse Events and Product Complaints. It is ultimately the decision of the PI to 
assess any undesirable medical condition and report as an AE.  
Clinical Exam of Operative Foot – The clinical examination of the operative foot should include, but 
not be limited to, inspection and palpitation of foot, assessment of hallux position, MTP joint range of 
motion and pain at the TMT joint (measured with manual stress exam and palpation of joint), pain under 
the 2nd and/or 3rd toe  at the ball of the foot, neurovascular exam including assessment for neuropathy, 
range of motion, passive correction of deformity, any other associated deformities. A dermatology 
examination of the operative foot should also be performed.  Any callus, skin inflammation, blisters or 
sores that occur at the MTP should be recorded.  
Adverse Event Assessment:  Refer to description of collection of Adverse Events (refer to Section 
10.1). This specifically includes complications of treatment intervention including wound/incision healing 
requiring intervention, hardware removal, revision procedure of the 1st ray and any other complication 
requiring surgical intervention.  
 
 

 
 
 
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Foot Measurements–  
Baseline and Pre-operatively  
Using a flexible tape measure, measure the circumference of the forefoot using the most 
prominent projection at the medial 1st metatarsal head and the lateral 5th metatarsal head as the 
starting reference points.  Measure in a circumferential manner.  Remove slack from the tape so 
that it lays flat on the skin.  
Using a flexible tape measure, measure the circumference of the foot using the 1st TMT 
articulation as the starting reference point. Determine the position of the TMT via manipulation 
of the metatarsal through a dorsiflexion/plantarflexion movement. Palpation and visualization of 
the joint puckering through the soft tissue will allow for the approximation of this landmark. 
Mark the area with a surgical marking pen for reference. If this is unsuccessful in allowing the 
surgeon to determine the level, a metallic bb marker can be placed on the skin and plain film 
radiographic imaging can be utilized to approximate the anatomy. Determine the TMT position 
and measure in a circumferential manner. Remove slack from the tape so that it lays flat on the 
skin.  
Using a flexible tape measure, measure the circumference of the ankle using the medial and 
lateral malleolus as reference points. Hold the measuring tape just superior to the inferior edge of 
the medial malleolus. Wrap the tape around the ankle, remove all slack and ensure the tape is flat 
on the lateral malleolus. The measurement should be made perpendicular to the longitudinal axis 
of the tibia and fibula.  
Measure the circumference of the mid-calf at the tibia. Approximate the Myotendinous junction 
of the gastroc. Measure the distance from this landmark to the popliteal fossa. Determine the 
midline and measure in a circumferential manner. Remove slack from the tape so that it lays flat 
on the skin.  
Post-operatively 
Using a flexible tape measure, measure the circumference of the forefoot using the most 
prominent projection at the medial 1st metatarsal head and the lateral 5th metatarsal head as the 
starting reference points.  Measure in a circumferential manner.  Remove slack from the tape so 
that it lays flat on the skin.  
Using a flexible tape measure, measure the circumference of the foot using the midpoint of the 
surgical incision as the starting reference point. Determine the midline and measure in a 
circumferential manner. Remove slack from the tape so that it lays flat on the skin.  
Using a flexible tape measure, measure the circumference of the ankle using the medial and 
lateral malleolus as reference points. Hold the measuring tape just superior to the inferior edge of 
the medial malleolus. Wrap the tape around the ankle, remove all slack and ensure the tape is flat 
on the lateral malleolus. The measurement should be made perpendicular to the longitudinal axis 
of the tibia and fibula.  
Measure the circumference of the mid-calf at the tibia. Approximate the Myotendinous junction of the 
gastroc. Measure the distance from this landmark to the popliteal fossa. Determine the midline and 
measure in a circumferential manner. Remove slack from the tape so that it lays flat on the skin.  

 
 
 
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Range of Motion – Dorsiflexion and plantarflexion should be measured while subject is passive and non-
weightbearing with the study provided goniometer. To measure ROM, the arms of goniometer should be 
lined up parallel to longitudinal axis of the 1st metatarsal and proximal phalanx of the hallux with the axis 
at the center of rotation of the first metatarsal head.  
Radiographic Measurements - Radiographic measurements will be analyzed by a third-party 
independent radiologist and entered into Clindex.  The radiographic measurements that will be collected, 
at a minimum, are provided in Appendix 4.  Additional exploratory radiographic measurements may be 
collected without requiring a protocol amendment.  
Index Procedure – See Section 7.2 for complete list of data collected during the Index Procedure. 
Concomitant procedures of the 1st ray should also be recorded.  These include but are not limited to, akin 
osteotomy, bone graft harvest (synthetic or allogenic bone graft substitutes are not permitted), 
intercuneiform stabilization, traditional medial eminence resection, rongeur of the medial capsular ridge, 
and/or dorsal metatarsal bone resection.  No concomitant procedures that alter the post-operative WB 
instructions are permitted (including evans and other calcaneal osteotomies, lesser TMT joint fusions, 
lisfranc or metatarsus adductus). Any complications during the procedure or deviations to the normal 
operative plans must also be recorded.  
POSAS: See Appendix 9. The Patient and Observer Scar Assessment Scale will be collected per the 
Assessment instructions.  
Return to Weight-Bearing Activities – The actual date that the subject was allowed to start to return to 
weight-bearing activities (protected WB in CAM boot, shoe and full unrestricted activities) should be 
recorded.  The number of days from index procedure will be calculated by Clindex. See Section 5.3 for 
post-operative care and weight-bearing instructions.  
Secondary Surgical Interventions: Any adverse event/complication that requires a subsequent 
secondary surgical intervention should be recorded.  The reason for the subsequent surgical intervention 
and the action taken should be recorded.  Subsequent secondary surgical interventions are defined as 
revisions, hardware removals, reoperations, supplemental fixations or other surgical intervention due to 
wound healing issues or infections at surgical site.  
Health Economic Outcomes: The date the subject was allowed to return to work (or normal household 
activities if non-working), should be recorded while noting work status and work classification 
(sedentary, light work, medium work, heavy work, very heavy work).  The date the subjects was allowed 
to return to full work (or full household activities if non-working), should be recorded while noting work 
status and work classification (sedentary, light work, medium work, heavy work, very heavy work – See 
Appendix 1 for definitions).  Any post-operative physical therapy requirements required for recovery of 
Lapiplasty® Procedure should be recorded. Any employment of home health services and the reason 
should be recorded. 
    
 
 

 
 
 
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8.0 
DATA MANAGEMENT AND INTEGRITY 
8.1 
Data Completion and Record Keeping 
8.1.1 
Source Documents 
Source documents are documents on which information regarding subjects are first recorded. PI subject 
files or hospital records generally are the basis of source document information. This may include but is 
not limited to, original subject files, hospital/clinic records, original recordings/tracing, and digital images 
from automated instruments, X-ray films, and laboratory results. 
 
Source documents must be retained by the PI as part of the subject’s permanent medical record. The 
information in the source documents is used to complete the eCRFs. All information captured on the 
eCRFs should be completely and accurately supported in source documentation.  Study Monitors will 
verify data reported on eCRFs with site source documents.  Any additional information relevant to the 
study should be included in the source documents. Any deviations from the study protocol or procedures 
should be recorded in the source documents. The PI will retain originals of all source documents, subject 
consent forms, and study data. 
 
8.1.2 
Data Collection 
An EDC system will be utilized by study site personnel to transfer study data from source records 
(medical records and/or source document worksheets) onto common eCRFs. This system is a web-based, 
secure electronic software application. This system is designed, developed, and maintained in a manner 
that is compliant with national and international GCP data protection/data privacy and electronic 
record/electronic signature (e.g., 21 CFR Part 11) regulatory requirements.  The platform software has 
been validated in accordance with 21 CFR Part 11, European Commission’s Directive on Data Protection 
and US Safe Harbor Certification.  Prior to being released for data entry, validation of the study level 
components (i.e., data entry screens, associated edit checks and workflow) will be conducted in 
accordance with approved user acceptance testing procedures. Access to this system will be controlled so 
that only authorized users will have the ability to enter into the system.  The system is considered a closed 
system according to 21 CFR Part 11 Electronic Records; Electronic Signatures. 
The EDC system will be used to facilitate the collection of all study data at the site. Designated site 
personnel will be responsible for entering subject data into the EDC system. All external and Sponsor 
internal users will be trained on the EDC application at a level dependent on their planned function.  
An EDC User Manual will be available to assist in the collection and entry of source data into the 
electronic casebook. 
Investigative study sites will be asked to enter subject data into the eCRFs no later than 2 weeks from the 
time the subject was seen for their scheduled study visit. 
Detailed description of the eCRF components is included in the eCRF Completion Instructions. These 
will be provided to the Investigators prior to initiating subject enrollment.  The respective eCRFs must be 
fully completed for each subject and signed electronically. 
Data collected during the clinical investigation for each subject will be maintained as accurately and 

 
 
 
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completely as possible with entries into an electronic data capture system provided by TMC.  The 
personal data recorded on all documents, including copy documents, and within the system will be 
regarded as confidential.  The Investigator will be responsible for the timing, completeness and accuracy 
of the details entered within the electronic data capture system.  All data entered into the database must 
have supporting source documentation in the subject’s medical records. 
Data will be entered into the electronic data capture system by members of the Investigational study site 
team who have received training in the use of the system.  The system will generate data queries at the 
point of data entry based on validation checks defined by TMC. Such validation checks will primarily be 
focused on validation of key variables including selected subject demographics, appropriate value ranges 
and date checks. Resolution of the queries will be the responsibility of the Principal Investigator and 
investigation team members.  Following completion of all data queries on each eCRF, the Principal 
Investigator will be responsible for reviewing and confirming agreement to the data within the system. 
The Investigator must record the subject’s participation in this clinical investigation in the subject’s 
hospital notes.  In addition, the Investigator must keep a separate list of all subjects entered into this 
clinical investigation showing each subject’s name, date of birth and assigned subject number (for 
identification purposes).  A Subject Identification Log will be provided in the Investigator’s File for this 
purpose. 
8.1.3 
Data Correction 
Corrections to eCRFs will be prompted via automated electronic edit checks and queries manually created 
by reviewers.  The corrections and the individual making the correction(s) to the eCRF will be made 
within the EDC system. 
8.1.4 
Investigator Regulatory Binder 
Each Investigator must maintain an accurate, complete and current copy of the Investigator Regulatory 
Binder.  Upon receipt of copies of changes or revision updates to the Binder from the Sponsor, the 
Investigator will add the updated document to the Regulatory Binder.  If an Investigator holds multiple 
copies of the Regulatory Binder, then all copies must be updated with the current revisions. 
8.1.5 
Study Correspondence 
Each Investigator and all personnel from the investigational site will maintain records of all 
correspondence, electronic, written, and verbal, relating to any aspect of the clinical investigation.  The 
records are maintained in the Investigator Regulatory Binder consisting of, but not limited to 
correspondence with other participating clinical investigators, the reviewing IRB, and the Sponsor.  The 
Clinical Research Associate (CRA) will examine the contents of the correspondence. 
8.1.6 
Data Privacy 
Subjects will be made aware that their personal data will be collected and processed in accordance with 
data protection legislation including the Health Insurance Portability and Accountability Act of 1996 

 
 
 
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(HIPAA). Subjects will be asked to sign an Authorization for Release of Personal Health Information 
(PHI) for the purpose of this investigation. This authorization may be combined with the ICF depending 
on local IRB preference.  Results from the Clinical Investigation may be published. However, subject 
confidentiality will be maintained at all times, and it will not be possible to identify individual subjects 
from any data presented.  
8.1.7 
Record Retention, Inspection, and Custody 
The PI must maintain all documentation related to the study until notified by the Sponsor. The PI will 
allow representatives of the Sponsor, IRB, the FDA, or other government regulatory agencies to inspect 
all study records, eCRFs, and corresponding portions of the subject’s office and/or hospital medical 
records at regular intervals during the study. These inspections are to verify adherence to the protocol, 
integrity of the data being captured on the eCRFs, and compliance with applicable regulations. 
Subject medical records will be kept confidential.  Study reports will not identify subjects by name.  
These reports may be submitted to the FDA and/or regulatory authorities.  
If custody of the records is transferred, notice of such a transfer should be given to the Sponsor no later 
than ten (10) working days after the transfer occurs. 
The Investigator should retain copies of all documents pertaining to this clinical investigation (including 
source documentation, the informed consent document and any other documents to identify the subjects) 
for at least 2 years after this clinical investigation is completed.  In addition, if the Clinical Investigator 
moves/retires, etc., he/she should provide TMC Inc. the name and address of the person who will look 
after and be responsible for the subjects’ clinical investigation related records. 
8.1.8 
Medical Dictionary Coding 
Medical dictionary coding will be performed using a coding thesaurus algorithm.  The MedDRA will be 
used upon data entry and query resolution for AEs and SAEs, via automated and manual coding 
processes. 
8.1.9 
Data Quality Assurance 
Quality control and quality assurance processes implemented during this study to ensure subject safety 
rights, and welfare are protected and to foster data integrity are characterized below. 
8.1.10 Investigator Training - Protocol Specific Training 
Protocol training will be scheduled once IRB approval is obtained, and the Clinical Study Agreement is 
executed.  TMC will train the study site on the protocol and that training will be documented.  It is 
ultimately the responsibility of the Investigator to ensure all clinical site personnel participating in this 
study are trained. 
The index procedure may only be performed by qualified investigators, familiar with the Lapiplasty® 
Procedure and related study procedures and techniques.   

 
 
 
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8.1.11 Monitoring 
This study will be monitored by the sponsor to ensure: 
• 
The rights, safety and well-being of the subjects are protected; 
• 
The reported study data is accurate, complete, and verifiable from source documents; and 
• 
The conduct of the study is in compliance with the currently approved 
protocol/amendment(s), applicable GCPs, and with applicable local/regional regulatory 
requirements. 
TMC, as Sponsor of this study, will be responsible for monitoring this study.  The CRA duties are to aid 
the Principal Investigator in the production and maintenance of complete, legible, well-organized and 
easily retrievable data.  In addition, the CRA will be responsible for assuring the Principal Investigator 
understands the protocol and all applicable regulations. Approaches to monitoring include on-site visits 
and may include remote visits, as appropriate, and the rationale and frequency for monitoring will be at 
the Sponsor’s discretion. The extent and nature of monitoring will be predetermined and based on 
considerations such as the objective, design, complexity, and endpoints of the study and mutually agreed 
to by the Sponsor. The frequency of monitoring will be determined for each site based on factors 
including:  the planned enrollment, the rate of enrollment, and the current study conduct.  Study conduct 
can be evaluated remotely based on compliance percentage, discrepancy rate and discrepancy type.  
CRAs will be trained on and comply with established standard operating procedures as well as a written 
monitoring plan specified by the Sponsor. 
To perform the monitoring role effectively, the CRA must verify eCRF entries with source documents.  
The CRA must be given access to primary subject data which supports the information recorded on the 
eCRF, i.e. hospital notes, appointment books, original laboratory records, etc.  Access to these documents 
must also be given to the regulatory authorities in the instance of an external inspection.  Since a subject 
has the right to refuse access to these documents on the grounds of confidentiality, consent to access is 
included in the informed consent document, which the subject signs. 
The Principal Investigator will receive reasonable notification prior to each monitoring visit during the 
course of this clinical investigation.  At each visit, the Principal Investigator will be expected to cooperate 
with the CRA for the review and verification of eCRFs and any additional records that may have been 
previously arranged between the Principal Investigator and the CRA. 
8.2 
Changes to Protocol, Protocol Deviations and Protocol Amendments 
8.2.1 
Changes to Protocol 
The Investigator should not implement any deviation from, or changes to the protocol without agreement 
by the sponsor and prior review and documented approval/favorable opinion from the IRB of an 
amendment, except where necessary to eliminate an immediate hazard(s) to study subjects, or when the 
change(s) involves only logistical or administrative aspects of the study (e.g., change in CRA(s), change 
of telephone number(s)). In the event of an emergency situation, the Investigator must notify the CRA or 
TMC immediately.  A full written report of the situation must be forwarded to the IRB who approved the 
original protocol and TMC within 10 working days of the event. 

 
 
 
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8.2.2 
Protocol Deviations 
The Investigator agrees to conduct the study in accordance with this protocol; however, protocol 
deviations may occur during the course of the study.  Protocol deviations are events occurring during the 
conduct of the study which are not in compliance with the protocol and for which an amendment has not 
been granted. Protocol deviations can be committed by the Sponsor, the PI, or the study subject. A 
deviation can be identified by a number of sources. Potential sources include but are not limited to: a 
member of the PI’s staff, the CRA during monitoring visits, or a member of the data management or 
statistical groups when entering or analyzing data.  The PI or PI’s representative are encouraged to 
contact the CRA or TMC as soon as possible upon observing a protocol deviation.  Regardless of the 
source, it is crucial to document the deviation and record all corrective actions. Protocol deviations will be 
reported in the final report. 
The process for capturing deviations will be detailed in the monitoring plan.  The process will require that 
documentation describe the deviation, and appropriate actions taken and will be included in the study file 
for the respective PI and subject.  The study site representative will be advised to record the deviation and 
relevant discussion with the Sponsor about the deviation in the subject’s source documentation. 
Protocol deviations affecting the scientific soundness of the study or the rights, safety, or welfare of the 
subjects, will be reported by the PI, as required by the IRB. 
Protocol deviations will be summarized and grouped into relevant categories for analysis and may 
include, but are not limited to, subjects who: 
• 
Entered the study although they did not satisfy the eligibility criteria;  
• 
Completed incorrect version of PROMIS based on age of subject 
• 
Did not return to protective weight-bearing activities by 3 weeks (+3 days);  
• 
Received Lapiplasty® Procedure (or other hallux valgus procedures) on contralateral 
foot less than 6 months after initial index procedure; or 
• 
Developed withdrawal criteria during the study but were not removed from study 
participation. 
 
8.2.3 
Protocol Amendments 
If it becomes necessary to amend the protocol, then the nature of the amendment will be agreed upon by 
the Sponsor and the Principal Investigator(s) and this will be recorded with a justification for the 
amendment. The appropriate IRBs will be informed of amendments prior to implementation of the 
change. 
9.0 
STATISTICAL CONSIDERATIONS 
In this prospective, single arm, non-comparative study, the analyses will be mainly descriptive.  
Inferential statistical methods, if applied, will be utilized to highlight the data aspect of interest.  Unless 
otherwise specified, statistical tests will be 2-sided using a 0.05 statistical significance level.  
Corresponding 95% confidence intervals will be presented as appropriate.  No corrections for multiple 

 
 
 
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testing will be applied.  Full details of all statistical issues and planned statistical analyses will be 
specified in a separate statistical analysis plan, which will be finalized prior to the locking of the study 
database.   
9.1 
Analysis of the Conduct of the Study 
The number of subjects enrolled in the study will be tabulated by the center. A subject disposition table 
will be tabulated, and will include the number of subjects enrolled, treated, and completing the study. 
Subject discontinuations and reasons for discontinuation will be summarized. 
9.2 
Sample Size 
There is no formal sample size calculation as this is a single arm study and is descriptive in nature. A 
sample size of 200patients is chosen, ensuring the feasibility of the study as clinical findings suggest that 
the bunion recurrence rate after the Lapiplasty® Procedure is low. 
9.3 
Analysis Population 
Intent-to-Treat (ITT) population: The ITT population is defined as all enrolled subjects who were treated 
with the Lapiplasty® Procedure using the Mini-Incision™ System. 
Per-Protocol (PP) Population: The per-protocol population is defined as all enrolled subjects who were 
treated with the Lapiplasty® Procedure using the Mini-Incision™ System who did not experience a major 
protocol violation.  Major protocol violations include, but are not limited to, subjects who: 
• 
Entered the study although they did not satisfy the eligibility criteria; 
• 
Completed incorrect version of PROMIS based on age of subject; 
• 
Did not return to protective weight-bearing activities by 3 weeks (+3 days);  
• 
Received Lapiplasty® Procedure (or other hallux valgus procedures) on contralateral foot less 
than 6 months after initial index procedure; or 
• 
Developed withdrawal criteria during the study but were not removed from study participation. 
9.4 
 Analysis of Study Endpoints 
All analyses of efficacy, safety, and health economic endpoints will use the ITT population. If the PP and 
ITT populations differ considerably, the PP population may be used for supportive efficacy analyses to 
evaluate the influence of major protocol violations on key endpoints.   
9.5 
Missing Data 
Efficacy and health economic analyses will be based on available data, without imputation for missing 
values.  For the Quality of Life outcomes, missing data will be handled as specified in the PROMIS-29, 
PROMIS-25 and MOxFQ scoring manuals.  For safety analyses, missing event dates will be imputed as 
follows: 
• 
If only month and year are reported, then day is assigned as the 15th of the month 

 
 
 
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• 
If only year is reported, then month and day is assigned as July 1st 
9.6 
Interim Analyses 
Interim analyses will be performed during the study according to patient enrollment and availability of 
data of interest.  Interim analyses will be used to provide early information about the safety and efficacy 
of the procedure and may be used for internal decision making, hypothesis generation, 
abstraction/publication for major orthopedic conferences, or other purposes, as applicable.  Interim 
analyses will follow the methods in the statistical analysis plan.  
9.7 
Safety Analyses 
AEs related to the Lapiplasty® Procedure and the Lapiplasty® devices will be reported on the eCRF.  
These AEs will be listed and descriptively summarized for all subjects.  No formal statistical hypothesis 
will be tested. 
9.8 
Detailed Analysis Plan 
Prior to database closure, a detailed statistical analysis plan will be finalized to completely specify the 
statistical procedures to be applied to the data by the statistician who will conduct the analysis. The plan 
will amplify the methods discussed in this protocol, will address any protocol changes that would affect 
the analysis, and will provide a rationale for any changes to the analysis. 
10.0 
SAFETY MONITORING 
Subject safety will be monitored throughout the course of this study by monitoring for Adverse Events 
and Product Complaints related to the Lapiplasty® Mini-Incision™ System Implants, the Lapiplasty® 
Mini-Incision™ Precision Instrument Set. The Lapiplasty® devices used during the index procedure for 
the clinical study have been cleared for marketing by the FDA and are being used within the current 
labeling and indications for use.  Any event that occurs that may have caused or contributed to a death or 
serious injury or that indicates that the devices have malfunctioned and would be likely to cause or 
contribute to a death or serious injury if the malfunction were to recur will be reported in compliance with 
21 CRF Part 803. 
In addition to general surgical risks (risks associated with anesthesia, infection, damage to nerves and 
blood vessels, and bleeding or blood clots), additional risks specifically associated with the Lapiplasty® 
System Implants are as follows: 
• 
Infection or adverse reaction for a foreign body; 
• 
Pain, discomfort, or abnormal sensations due to the presence of the implant; 
• 
Loosening, bending, cracking or fracture of the components or loss of fixation of bone 
attributable to nonunion, osteoporosis, markedly unstable comminuted fractures;  
• 
Loss of anatomic position with nonunion or malunion with rotation or angulation; 
• 
Migration of the implant, loosening of the implant; 
• 
Delayed correction in alignment; 
• 
Decrease in bone density due to stress shielding; 

 
 
 
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• 
Bursitis; 
• 
Additional surgery if the device is not placed in the correct position. 
Metallic implants can loosen, fracture, corrode, migrate, cause pain, or stress shield bone even after a 
fracture is healed.  If any of these complications occur, the surgeon must make the final decision on 
implant removal.  
There may also be other risks that are unforeseen at this time. The complete Risk/Benefit Assessment is 
found in Appendix 5. 
10.1 
Adverse Events 
10.1.1 Definition of an Adverse Event 
Adverse Event (AE): any undesirable clinical occurrence or change from a patient’s baseline (pre-index 
procedure) condition, whether it is device related or not. 
 
Adverse Event Identification: a condition that is one of the following: 
a. A unique symptom or event that is a change from the subject’s baseline status 
b. A series of symptoms or events that can be categorized as a single entity  
c. A specific diagnosis responsible for a clinical change 
d. A worsening or exacerbation of a pre-existing condition 
10.2 
Serious Adverse Events 
10.2.1 Definition of a Serious Adverse Event 
Serious Adverse Event (SAE): any adverse event is considered serious if it results in death, is life 
threatening, requires hospitalization (initial or prolonged), results in disability or permanent damage, 
causes congenital anomaly/birth defect, requires intervention to prevent impairment or damage, or other 
serious (important medical events) which may jeopardize the subject and may require medical or surgical 
intervention to prevent one of the above outcomes. 
Note: “Death” should not be reported as an adverse event.  The cause of death should be reported as an 
adverse event.  The only exception is “Sudden Death” when the cause is unknown. 
10.2.2 Subject Death 
Subject death during the investigation must be reported by the Investigator (or designee) by completing 
the Study Exit eCRF in the database along with the cause of death.  The electronic Adverse Event Form is 
necessary if the event was related to the Lapiplasty® devices or placement of the device.  In addition, 
subject death must be reported to the IRB in accordance with IRB requirements.  
10.2.3 Adverse Event Classification 
The investigator is required to provide: 
• 
Time interval of the event – The time interval of the occurrence of the adverse event should be 
assessed in relationship to timing of the index procedure (Lapiplasty® Procedure) 
• 
Date of event onset and outcome of the event, or date of death 

 
 
 
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• 
Severity of the event – (Mild, Moderate, Severe) 
• 
Action taken for medical management of the event 
• 
Relationship of the event – it is the PIs responsibility to assess the relationship of an AE and 
provide primary cause.  Events will be categorized by relationship to the Lapiplasty® System 
Implants, the Lapiplasty® System Reusable Instruments, or the index procedure (Lapiplasty® 
Procedure). 
• 
Adverse events will be assessed to determine if the event meets the definition of a serious adverse 
event.   
10.2.4 Reporting Adverse and Serious Adverse Events 
The investigator (or designee) will record all AEs (both serious and non-serious and regardless of 
relationship) in the source documents.  The Investigator at each participating site is responsible for 
reporting AEs and SAEs to TMC only when they are related to the Lapiplasty® Procedure, the 
Lapiplasty® Mini-Incision™ System Implants and Lapiplasty® Mini-Incision™ Precision Instrument 
Set. AEs related to the Lapiplasty® Procedure or Lapiplasty® devices will be reported on the eCRF.  The 
CRF allows the investigator to indicate whether an adverse event is related to the Lapiplasty® System 
devices or Lapiplasty® Procedure (index procedure). 
• 
Use a separate Adverse Event Form to document each event 
• 
The Adverse Event Form must be electronically signed by the Investigator 
Note: It is the responsibility of the Investigator to inform their IRB of SAEs as required by their 
IRB procedures and in conformance with FDA requirements. 
 
For the purposes of this study, the following adverse events are not considered reportable (recorded on 
eCRF) because they are normally expected to occur in conjunction with surgical treatment for hallux 
valgus procedures or are associated with customary and standard care of patients undergoing surgical 
treatment of hallux valgus or other protocol approved and acceptable concomitant procedures. If any of 
these events are beyond what is normally expected after the Lapiplasty® Procedure, they should be 
reported as AEs.  However, the decision to report any AEs is ultimately the decision and responsibility of 
PI.  
• 
Post-operative pain/post-procedure pain 
• 
Minor, localized tenderness, swelling, induration, oozing, etc. at surgical site 
• 
Temporary numbness or tingling at surgical site  
• 
Elevated White Blood Cell count without signs and symptoms of infection 
• 
Stiffness/weakness of joint 
Note: Subjects will undergo general anesthesia and therefore will also be subject to general 
anesthesia-associated complications and morbidity.  These are also not considered reportable 
(recorded on eCRF) adverse events. 
Any pre-planned surgical procedures 
• 
Any pre-planned surgical foot procedures at the time of informed consent will not be considered 
reportable (recorded on eCRF) adverse events (whether hospitalization is required or not).   
All Serious Adverse Events that are related to the index procedure or the Lapiplasty® devices must be 
reported by the Investigator by submitting the AE eCRF to TMC within 10 days of becoming aware of 

 
 
 
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the AE and recorded on the Serious Adverse Event Source Document Collection Form.  Any event 
determined by the Investigator to be life threatening or to have led to death should be reported within 24 
hours. 
The Investigator shall send a written report including a narrative description of the SAE to TMC within 
three (3) working days of the initial report.  The Investigator should follow all unresolved SAEs until the 
events are resolved, or the subject has exited the study, or the AE is otherwise explained.  
11.0 
PRODUCT COMPLAINTS 
11.1 
Product Complaint Definition 
A product complaint is any written, electronic, or oral communication that alleges deficiencies related to 
the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is 
released for distribution.  A product complaint may or may not be associated with an AE/SAE. 
11.2 
Source of Product Complaint Data 
Means of obtaining product complaint data include review of the subject’s medical records or observation 
by the PI and/or study staff, TMC employees observing study cases or identified by the Central 
Radiologist during review of radiographs.  The PI and/or study staff are responsible for completing the 
required study documentation and the eCRFs.  
11.3 
Medical Device Reporting and Product Complaints 
All reported device observations, malfunctions, or failures for the Lapiplasty® System products (Implants 
and Reusable Instruments) will be reported on the Product Experience Report (Appendix 6) within 10 
days of observation of the Product Complaint via email to pe@treace.net.  In the event of a suspected 
observation or device problem, the device shall be returned to the sponsor for analysis.  The 
Investigational Device Observation eCRF should be completed, for the Lapiplasty® System Implants 
only, within 10 days of a suspected observation or device problem.  Any device observations, 
malfunctions or failures for the Reusable Instruments will be reported by established TMC standard 
operating procedures, unless it is associated with a reportable AE/SAE.  
Whenever an event involving a TMC device is subject to reporting under that Medical Device Reporting 
(MDR) regulation, TMC shall submit to the FDA the appropriate reports required by MDR within the 
time frames as identified in 21 CFR Part 803.  Criteria for reporting malfunctions and potentially serious 
injuries is based on interpretations of medical intervention, potential for serious injury, and impact of a 
malfunction to a device’s essential functionality.  TMC will follow applicable internal quality system 
procedures which are in compliance with reporting obligations as required by 21 CFR Part 803 and 21 
CFR Part 820: Code of Federal Regulations, Quality System Regulations. 
Possible Product Complaints 
• 
Intra-Operatively 
o Device malfunction or failures 
o Injury or bone fractures 
• 
Post-Operatively 
o Revision surgery (due to pain, discomfort, infection, wound healing complications, 

 
 
 
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hardware removal, malunion, or non-union) 
o Infection or allergic reaction 
o Injury 
• 
Radiographically 
o Broken hardware (screw/plate) 
o Loose, bent, cracked, fractured screw/plate 
o Bone infection 
o Migration of screw/plate 
o Bone fractures 
12.0 
STUDY OVERSIGHT 
12.1 
Independent Oversight 
An independent central radiologist will perform the radiographic measurements for all sites/subjects.  Any 
notable outliers in radiographic measurements/result will be reviewed by the medical monitor and/or the 
lead PI for resolution.   

 
 
 
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Works Cited 
Bibliography 
1. Bock P, et al., The Scarf Osteotomy with Minimally Invasive Lateral Release for Treatment of Hallux 
Valgus Deformity: Intermediate and Long-Term Results. J Bone Joint Surg Am. 2015; 97:1238-45. 
2. Jeuken RM, et al., Long-term Follow-up of a RCT Comparing Scarf to Chevron Osteotomy in Hallux 
Valgus Correction. Foot Ankle Int. 2016; 37:687-95. 
3. Kim Y, et al. A New Measure of Tibial Sesamoid Position in Hallux Valgus in Relation to the Coronal 
Rotation of the First Metatarsal in CT Scans.  Foot Ankle Int. 2015; 36:944-52. 
4. Okuda R, et al. The Shape of the Lateral Edge of the First Metatarsal Head as a Risk Factor for 
Recurrence of Hallux Valgus. J Bone Joint Surg Am. 2007; 89:2163-72. 
5. Okuda R, et al., Postoperative Incomplete Reduction of the Sesamoids as a Risk Factor for Recurrence 
of Hallux Valgus. J Bone Joint Surg Am. 2009; 91:1637-45. 
6. Dayton P, Feilmeier M., Comparison of Tibial Sesamoid Position on Anteroposterior and Axial 
Radiographs Before and After Triplane Tarsal Metatarsal Joint Arthrodesis.  J Foot Ankle Surg. 2017; 
56:1041-1046. 
7. Ray JJ, et al., Multicenter Early Radiographic Outcomes of Triplanar Tarsometatarsal Arthrodesis with 
Early Weightbearing. Foot Ankle Int. 2019; 40(8):955-960. 
 
 
 
 

 
 
 
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13.0 
APPENDICES 
APPENDIX 1 – WORK CLASSIFICATION 
Exertional levels as outlined in the Standards of U.S. Department of Labor as defined in the Dictionary of 
Occupational Titles (DOT)  
  
• SEDENTARY: work involves exerting up to 10 pounds of force occasionally or a negligible amount of 
force frequently to lift, carry, push, pull, or otherwise move objects, including the human body. Sedentary 
work involves sitting most of the time but may involve walking or standing for brief periods of time. Jobs 
may be defined as Sedentary when walking and standing are required only occasionally, and all other 
Sedentary criteria are met.   
  
• LIGHT: work involves exerting up to 20 pounds of force occasionally, or up to 10 pounds of force 
frequently, or a negligible amount of force constantly to move objects. Physical demand requirements are 
in excess of those for Sedentary Work. Even though the weight lifted may be only a negligible amount, a 
job/occupation is rated Light Work when it requires: (1) walking or standing to a significant degree; (2) 
sitting most of the time while pushing or pulling arm or leg controls; or (3) working at a production rate 
pace while constantly pushing or pulling materials even though the weight or the materials is negligible. 
(The constant stress and strain of maintaining a production rate pace, especially in an industrial setting, 
can be and is physically demanding of a worker even though the amount of force exerted is negligible.)   
  
• MEDIUM: work involves exerting 20 to 50 pounds of force occasionally, or 10 to 25 pounds of force 
frequently, or an amount greater than negligible and up to 10 pounds constantly to move objects. Physical 
demand requirements are in excess of those for Light Work.   
  
• HEAVY: work involves exerting 50 to 100 pounds of force occasionally, or 25 pounds of force 
constantly to move objects. Physical demand requirements are in excess of those for Medium Work.     
 
•VERY HEAVY: work involves exerting 100 pounds of force occasionally, or 50 pounds of force 
constantly to move objects. Physical demand requirements are in excess of those for Heavy Work.   
 
 
 

 
 
 
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APPENDIX 2A – VISUAL ANALOG SCALE 
 
Visual Analog Scale (VAS) 
Foot Pain Intensity 
Read Each Scale Definition And Answer According To Current Pain In Your Foot 
0–10 Numeric Pain Rating Scale 
 
 
 
 
 
 
 
 
 
 

 
 
 
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APPENDIX 2B – VISUAL ANALOG SCALE – US-SPANISH TRANSLATION 
 
 
Escala analógica visual (VAS) 
Intensidad del dolor de pie 
 Escala de calificación numérica del dolor de 0 a 10 
0–10 Numeric Pain Rating Scale 
 
 
 
 
 

 
 
 
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APPENDIX 3A – QUALITY OF LIFE (QOL) TOOLS                                                       
(PROMIS-29, PROMIS-25 and MOxFQ) 
 
 

 
 
 
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APPENDIX 3B – QUALITY OF LIFE (QOL) TOOLS                                                       
(PROMIS-29, PROMIS-25 and MOxFQ) – US-SPANISH TRANSLATIONS 
 

 
 
 
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APPENDIX 4 – RADIOGRAPHIC MEASUREMENTS 
NOTE: The following measurements will be collected at a minimum by the Central Radiologist.  
Visit 1 measurements made by the Central Radiologist are not utilized for determining patient 
eligibility. Additional measurements may be collected for exploratory purposes without 
amendment to the protocol.  
Visit 1  
• IMA (Intermetatarsal angle)  
• HVA (Hallux Valgus Angle)  
• Lateral Round Sign Present   
• TSP (Tibial Sesamoid Position) 
• MAA (Metatarsus Adductus)  
• Metatarsal Rotation  
• Sesamoid Subluxation 
 
 
• Sagittal-Plane 1st Metatarsal Position  
• Meary’s Angle  
• AP Talar -1st Metatarsal Angle 
• Osseous Foot Width 
• 1-2 Metatarsal Length 
• MTP (Metatarsal Phalangeal) Osteoarthritis  
• Metatarsal-Sesamoid Osteoarthritis  
• DMAA 
• Sagittal 1st Ray Length 
Visit 5  
• IMA (Intermetatarsal angle)  
• HVA (Hallux Valgus Angle)  
• Lateral Round Sign Present   
• TSP (Tibial Sesamoid Position) 
• MAA (Metatarsus Adductus)  
• Metatarsal Rotation  
• Post-Operative Metatarsal Rotation  
• Sesamoid Subluxation 
 
 
• Sagittal-Plane 1st Metatarsal Position  
• Meary’s Angle  
• AP Talar -1st Metatarsal Angle 
• MTP (Metatarsal Phalangeal) Osteoarthritis  

 
 
 
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• Metatarsal-Sesamoid Osteoarthritis  
• Hardware issues, potential complications or adverse events based on radiographic 
review  
 
Visits 6 -9 
• IMA (Intermetatarsal angle)  
• HVA (Hallux Valgus Angle)  
• Lateral Round Sign Present   
• TSP (Tibial Sesamoid Position) 
• MAA (Metatarsus Adductus)  
• Metatarsal Rotation  
• Post-Operative Metatarsal Rotation  
• Sesamoid Subluxation 
 
 
• Sagittal-Plane 1st Metatarsal Position  
• Meary’s Angle  
• AP Talar -1st Metatarsal Angle 
• Osseous Foot Width 
• 1-2 Metatarsal Length 
• MTP (Metatarsal Phalangeal) Osteoarthritis  
• Metatarsal-Sesamoid Osteoarthritis 
• DMAA 
• Sagittal 1st Ray Length  
• Lucency at arthrodesis: Yes/No 
• Hardware Failure (transverse screw) 
   
o If Yes, location of screw(s): C1-C2 or C1-M2 
• Hardware Failure (screws or plates at 1st TMT Joint) 
• Hardware issues, potential complications or adverse events based on radiographic 
review  
 
  
 
 
 
 

 
 
 
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APPENDIX 5 – RISK/BENEFIT ASSESSMENT 
 
Summary:  The Mini3D™ study is being undertaken to evaluate outcomes of the Lapiplasty® Procedure 
for patients in need of hallux valgus surgery.  Subjects meeting inclusion/exclusion criteria and 
undergoing the Lapiplasty® Procedure will participate in this study.  The risks of participation are offset 
by the potential for clinical and functional benefits.  
 
1.0 
POTENTIAL BENEFITS: 
The potential benefit to study subjects outweighs the risks of participation in this study.  Benefits may 
include but are not limited to, the following: 
• 
Clinical improvement – patients may experience effective and long-lasting correction of the 
anatomical alignment of the entire metatarsal bone in all three planes, naturally removing the 
bump and straightening the toe. 
• 
Functional improvement – patients may experience the ability to put weight on their foot within 
days after their surgery, allowing them to return to normal activities within 4-6 weeks. Patients 
may also experience improved patient satisfaction and improve pain caused by the bunion after 
the Lapiplasty® Procedure through a Mini-Incision™ Approach.  
• 
Post-operative experience improvement – patients may experience less pain and scarring after the 
Lapiplasty® Procedure through a Mini-Incision™ approach.  
• 
Overall advancement of medical and scientific knowledge – Information obtained from this study 
may further our understanding of how early weight-bearing after the Lapiplasty® Procedure 
impacts healing of the bone and recurrence of the bunion over time. 
 
There may be other benefits that are unforeseen at this time.   
 
2.0 
POSSIBLE RISKS AND DISCOMFORTS: 
Risk Category: Minimal 
Independent from this research study, the patient is already a candidate for hallux valgus treatment with 
the Lapiplasty® Procedure in the commercial setting.  The Lapiplasty® System is cleared for use and in 
this research study it is used in accordance with approved product labeling. All risks for this procedure 
will have been discussed between the patient and the surgeon and a surgical consent will have been 
signed.  Similarly, anesthetic risks will have been discussed and anesthetic consent will have been signed.  
The participant will have been fully informed of the risks of this study.  
Possible risks and discomforts that may be associated with the use of the Lapiplasty® Procedure and 
Lapiplasty® System (Implants and Reusable Instruments): 
• 
Infection or adverse reaction for a foreign body; 
• 
Pain, discomfort, or abnormal sensations due to the presence of the implant; 
• 
Loosening, bending, cracking or fracture of the components or loss of fixation of bone 
attributable to nonunion, osteoporosis, markedly unstable comminuted fractures;  

 
 
 
Study Number: CP2021-1 
CONFIDENTIAL 
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Record: Clinical Study Protocol 
 
 
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• 
Loss of anatomic position with nonunion or malunion with rotation or angulation; 
• 
Migration of the implant, loosening of the implant; 
• 
Delayed correction in alignment; 
• 
Decrease in bone density due to stress shielding; 
• 
Bursitis; 
• 
Additional surgery if the device is not placed in the correct position. 
Possible risks and discomforts that may be associated with the use of the Lapiplasty® Mini-Incision™ 
Positioner: 
• 
Necrosis; 
• 
Bruising; 
• 
Blistering;  
• 
Tissue ulceration. 
Metallic implants can loosen, fracture, corrode, migrate, cause pain, or stress shield bone even after a 
fracture is healed.  If any of these complications occur, the surgeon must make the final decision on 
implant removal.  
There may also be other risks that are unforeseen at this time. 
 
3.0 
MINIMIZATION OF RISKS 
Measures which will be taken to minimize risks related to the study include: 
• 
Investigators selected for participation in this study will have experience in treating patients with 
hallux valgus and performing surgical procedures. 
• 
Investigators selected for participation in this study will be qualified to complete study index 
procedure (Lapiplasty® Procedure) and are experienced in the use of the Lapiplasty® Mini-
Incision™ (Implants and Reusable Instruments). 
• 
Well defined clinical study protocol, including specific inclusion/ exclusion criteria to enroll 
appropriate patients in the trial. 
• 
Close patient monitoring during the Lapiplasty® Procedure and patient follow-up period. 
Alternative to Participation:  Patients may decline participation in the study and would be treated with 
the same standard of care.   
CONCLUSION:  This clinical study is justified because the study sponsor and clinical investigators 
believe the potential benefits outweigh the potential risks. 
 
 
 
 
 

 
 
 
Study Number: CP2021-1 
CONFIDENTIAL 
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Record: Clinical Study Protocol 
 
 
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APPENDIX 6 – PRODUCT EXPERIENCE REPORT 
NOTE: An example of the Product Experience Report form is provided below.  The form may be updated 
by Treace Medical Concepts, Inc. and does not require an amendment to the study protocol.  Sites will be 
provided current revisions of the Product Experience Report form, as required, if revisions are made to 
the form through the course of the study.   

 
 
 
Study Number: CP2021-1 
CONFIDENTIAL 
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Record: Clinical Study Protocol 
 
 
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APPENDIX 7 – SUBJECT FOLLOW-UP VISIT CARD 
 
Exact layout of card may vary.  Information will remain consistent.  
SIDE 1 
SIDE 2 
 
Site Contact Information for Study Related 
Questions: 
CONTACT DETAILS OF YOUR STUDY 
DOCTOR 
Study Protocol Number: CP2021-1 
Name: 
Subject’s Name: 
Address: 
Subject’s Study Number: 
City:                                        State: 
 
Telephone: 
Your Next Study Visit is scheduled for: 
 
 
Alternative Contact Name:  
Visit (insert visit #): (insert scheduled visit date) 
Phone: 
Thank you for participating in this important 
clinical study to evaluate the outcomes of the 
Lapiplasty® Procedure that could help patients 
long into the future.  
On behalf of everyone involved with this clinical 
study, we want to Thank You for your 
participation. Don’t hesitate to contact the 
medical team to answer any questions you may 
have.   
 
 
 

 
 
 
Study Number: CP2021-1 
CONFIDENTIAL 
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Record: Clinical Study Protocol 
 
 
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APPENDIX 8 – ADVERTISEMENT/FLIER FOR IRB APPROVAL 
Mini3D™ Clinical Study (CP2021-1) 
Planned for multimedia advertising: Waiting Room Flier, Newspaper, Billboard, Radio Script, 
Hospital Journal, Website, Facebook, email blog, email blast to client base, Posters, mailed 
letters, and other modes of media as identified. Imagery (or site/facility specific information) may 
be added to advertisement for use at the local site level.  
Clinical Research Study for the Treatment of Bunions 
Painful Bunion? 
If you are suffering from a painful bunion, or are considering bunion surgery, you may qualify for a 
medical research study to evaluate the outcomes of an FDA-cleared surgical treatment for bunion 
correction.   
To qualify, you must meet of the study criteria including: 
• 
Must be between 14-58 years of age 
• 
Have a qualifying bunion that requires surgical correction  
 
While participating in this study, data on your procedure outcomes will be collected and you will be 
asked to complete assessments so that the study sponsor can learn more about your experience 
with this procedure.   
To find out more about this study and to see if you qualify, please ask to speak with (insert name) 
or call (insert number) and reference the “Lapiplasty© Mini3D™ Clinical Study”.  
 
You may be compensated for study-related time and travel.  
Insert PI Name 
Insert full site address 
Insert Phone 
 
 
 
 

 
 
 
Study Number: CP2021-1 
CONFIDENTIAL 
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Record: Clinical Study Protocol 
 
 
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APPENDIX 9A –  
THE PATIENT AND OBSERVER SCAR ASSESSMENT SCALE (POSAS) 
 
 
 

 
 
 
Study Number: CP2021-1 
CONFIDENTIAL 
Page 77 of 81 
Record: Clinical Study Protocol 
 
 
Version date: 04/Apr/2023 / Rev: E 
 
 
 

 
 
 
Study Number: CP2021-1 
CONFIDENTIAL 
Page 78 of 81 
Record: Clinical Study Protocol 
 
 
Version date: 04/Apr/2023 / Rev: E 
 
 
APPENDIX 9B –  
THE PATIENT AND OBSERVER SCAR ASSESSMENT SCALE (POSAS) – US-
SPANISH TRANSLATIONS 
 

 
 
 
Study Number: CP2021-1 
CONFIDENTIAL 
Page 79 of 81 
Record: Clinical Study Protocol 
 
 
Version date: 04/Apr/2023 / Rev: E 
 
 
 

 
 
 
Study Number: CP2021-1 
CONFIDENTIAL 
Page 80 of 81 
Record: Clinical Study Protocol 
 
 
Version date: 04/Apr/2023 / Rev: E 
 
 
APPENDIX 10A – GENERAL SATISFACTION QUESTIONNAIRE 
 
 
General Satisfaction Questionnaire - Lapiplasty® Procedure through a Mini-Incision™ Approach 
  
Would you 
recommend the 
procedure to your 
relatives? 
Yes  
No 
  
  
  
  
  
  
Would you 
undergo the same 
procedure again? 
Yes  
No 
  
Rate your 
satisfaction on 
the following 
specific aspects 
of the procedure: 
  
  
  
  
  
Pain: 
Very Unsatisfied 
Unsatisfied 
Neutral 
Satisfied 
Very Satisfied 
Function: 
Very Unsatisfied 
Unsatisfied 
Neutral 
Satisfied 
Very Satisfied 
Alignment: 
Very Unsatisfied 
Unsatisfied 
Neutral 
Satisfied 
Very Satisfied 
Aesthetics: 
Very Unsatisfied 
Unsatisfied 
Neutral 
Satisfied 
Very Satisfied 
  
Rate your overall 
satisfaction with 
results of the 
procedure: 
Very Unsatisfied 
Unsatisfied 
Neutral 
Satisfied 
Very Satisfied 
  
 
 
 

 
 
 
Study Number: CP2021-1 
CONFIDENTIAL 
Page 81 of 81 
Record: Clinical Study Protocol 
 
 
Version date: 04/Apr/2023 / Rev: E 
 
 
APPENDIX 10B – GENERAL SATISFACTION QUESTIONNAIRE – US-SPANISH 
TRANSLATION