A Post-Market Clinical Evaluation of the Treatment of Tibia Fractures With the T2 Alpha Tibia Nailing System
Conditions: Tibial Fractures
Sponsor: Stryker Trauma and Extremities

T2 Alpha Tibia CIP  Version 3 
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T2 Alpha Tibia Clinical Investigation Plan
CLINICAL INVESTIGATION 
TITLE: 
A Post-Market Clinical Evaluation of the Treatment of Tibia
Fractures with the T2 Alpha Tibia Nailing System 
ABBREVIATED CLINICAL 
INVESTIGATION TITLE: 
T2 Alpha Tibia 
DEVICE NAME: 
T2 Alpha Tibia Nailing System 
CLINICAL INVESTIGATION 
DESIGN: 
Post-Market,  
Multicenter,  
Prospective, 
Non-Randomized 
INDICATIONS: 
This clinical investigation will adhere to the indications and 
contraindications for the T2 Alpha Tibia Nailing System as are 
REGULATORY STATUS 
K180436 - 510(k) clearance received on 06Jun2018 
CLINCIAL INVESTIGATION 
PLAN PHASE: 
Post-Approval Clinical Investigation 
SPONSOR: 
Stryker Orthopaedics 
325 Corporate Drive 
Mahwah, NJ 07430 
INVESTIGATORS: 
MEDICAL EXPERT: 
Dr. Thomas Demuth, M.D. 
E 
CLINICAL RESEARCH HEAD: 
Rebecca Gibson 
COMPLIANCE STATEMENT: 
This clinical investigation will be conducted in compliance 
with the Clinical Investigation Plan, International Conference 
of Harmonisation Good Clinical Practice (ICH-GCP), and all 
other applicable regulatory requirements, including the 
retention of essential documents. Investigators will be trained 
on the clinical investigation devices and surgical techniques 
prior to implanting clinical investigation subjects. 
CONFIDENTIALITY 
STATEMENT: 
This Clinical Investigation Plan contains confidential 
f 
intending to conduct the clinical investigation, Institutional 
Review Boards (IRBs)/Ethics Committees (ECs) and any 
others charged with reviewing the clinical investigation. 
VERSION: 
3 
DATE: 
23Nov2020 
NCT04015167

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Approval Page
APPROVERS
Role
Name
Signature
Date
Medical Expert
Dr. Thomas Demuth
Clinical Research 
Head (CRH)
Rebecca Gibson
Regulatory Affairs 
(RA)
Cindy Leon
Statistician
Claudia Beimel

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Table of Contents
1. 
LIST OF ABBREVIATIONS ......................................................................................................... 4 
2. 
SYNOPSIS ...................................................................................................................................... 5 
3. 
GENERAL INFORMATION AND ADMINISTRATIVE STRUCTURE .................................... 6 
4. 
PRODUCT INFORMATION ......................................................................................................... 7 
5. 
RISKS AND BENEFITS ................................................................................................................ 7 
6. 
INTRODUCTION ........................................................................................................................... 7 
7. 
CLINICAL INVESTIGATION DESIGN ....................................................................................... 7 
8. 
OBJECTIVE .................................................................................................................................... 8 
9. 
SELECTION OF CLINICAL INVESTIGATION POPULATION ................................................ 8 
10. CLINICAL INVESTIGATION EVALUATIONS, PROCEDURES AND ASSESSMENTS ..... 10 
11. STATISTICAL METHODS ......................................................................................................... 12 
12. CLINICAL INVESTIGATION PLAN DEVIATIONS ................................................................ 18 
13. ADVERSE EVENTS/INCIDENTS .............................................................................................. 18 
14. REOPERATIONS ......................................................................................................................... 20 
15. ETHICS ......................................................................................................................................... 20 
16. DATA COLLECTION PROCESS................................................................................................ 21 
17. CLINICAL INVESTIGATION MONITORING .......................................................................... 21 
18. DATA HANDLING AND RECORD KEEPING ......................................................................... 21 
19. REPORTS ..................................................................................................................................... 21 
20. PUBLIC REGISTRATION ........................................................................................................... 21 
21. COMPLETION OF THE CLINICAL INVESTIGATION ........................................................... 21 
22. ESSENTIAL DOCUMENTS ........................................................................................................ 22 
23. PUBLICATION POLICY ............................................................................................................. 22 
24. REFERENCES .............................................................................................................................. 22 
25. CLINICAL INVESTIGATION PLAN SIGNATURE PAGE ...................................................... 24 
26. DOCUMENT VERSION HISTORY ............................................................................................ 25 
 
 

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1. List of Abbreviations
Acronym 
Definition 
ADE 
 
Adverse Device Effect 
AE 
 
Adverse Event 
CI 
 
Confidence Interval 
CIP 
 
Clinical Investigation Plan 
CRF 
 
Case Report Form 
eCRF 
 
Electronic Case Report Form 
EC 
 
Ethics Committee 
EDC 
 
Electronic Data Capture 
EUDAMED 
European Database on Medical Device 
ICF 
 
Informed Consent Form 
ICH-GCP 
International Conference of Harmonisation Good Clinical Practice 
IFU 
 
Instructions for Use 
ITT 
 
Intent-to-Treat 
Intra-Op  
Intra-Operative 
IRB 
 
Institutional Review Board 
LTFU 
 
Lost to Follow-Up 
MCS 
 
SF-36 Mental Component Summary 
MDD 
 
Medical Device Directive 
MDR 
 
Medical Device Regulation  
PCS 
 
SF-36 Physical Component Summary 
PP 
 
Per Protocol 
Pre-Op  
Pre-Operative 
SADE  
Serious Adverse Device Effect 
SAE 
 
Serious Adverse Event 
SAP  
 
Statistical Analysis Plan 
SF-36v2  
36-Item Short Form Health Survey 
UADE  
Unanticipated Adverse Device Effect 
 
 
 
 
 
 
 
 
 
 
 
 
 

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2. Synopsis
Title 
A Post-Market Clinical Evaluation of the Treatment of Tibia Fractures with the T2 Alpha Tibia
Nailing System 
Treatment 
T2 Alpha Tibia Nailing System 
Design 
 
Post-Market 
 
Multicenter 
 
Prospective 
 
Non-Randomized 
Objective 
The objective of this clinical investigation is to demonstrate the safety and 
efficacy/performance of the T2 Alpha Tibia Nailing System. 
Efficacy/performance of the procedure will be measured by an equal or higher (non-inferior) 
SF-36 Physical Component Summary (PCS) score result of the T2 Alpha Tibia Nailing 
System compared to the T2 Tibia benchmark literature (Wang, et al. 2017; Sanders, et al. 
2014; Sun, et al. 2016; Chan, et al. 2016) at 12 months.  
In addition, demonstration of bone consolidation in correct alignment will be measured by 
Investigator assessment by 12 months. 
Safety of the T2 Alpha Tibia Nailing System will be demonstrated through reporting of device 
related intra-operative and post-operative Adverse Events/incidents by 12 months. 
Target 
Population 
Approximately 80 subjects are to be enrolled in this clinical investigation at up to 5 sites.
Enrolled subjects will be assessed at Operative/Discharge, and at 3 Months, 6 Months and 12 
Months after the index procedure.  
Inclusion 
Criteria 
a. 
Subject is a male or non-pregnant female age 18 years or older at the time of surgery; 
b. 
Subject is willing and able to give written informed consent and comply with the 
requirements of this Clinical Investigation Plan; 
c. 
Subject is intended to be treated with the Tibial Nail of the T2 Alpha Tibia Nailing 
System in accordance with the following legally cleared/ approved Indications for Use:
Indications for Use approved In United States and Canada include: 
 
Open and closed tibial fractures 
 
Pseudoarthrosis and correction osteotomy 
 
Pathologic fractures, impending pathologic fractures and tumor resections 
 
Fractures involving osteopenic and osteoporotic bone 
 
Nonunions and malunions 
Indications for Use approved In Europe and Other Countries include: 
 
Open and closed tibial fractures 
 
Nonunions and malunions 

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Exclusion 
Criteria 
a.
Subject has an active or suspected latent infection or marked local inflammation in or 
about the affected area 
b. 
Subject has compromised vascularity that would inhibit adequate blood supply to the 
fracture or the operative site 
c. 
Subject has documented bone stock compromised by disease, infection or prior 
implantation which cannot provide adequate support and / or fixation of the device 
d. 
Subject has documented or suspected sensitivity to materials    
e. 
Subject is obese such that he / she produces a load on the implant which can lead to 
failure of fixation of the device or to failure of the device itself 
f. 
Subject has inadequate tissue coverage over the operative site. 
g. 
Subject has implant utilization that would interfere with anatomical structures or 
physiological performance 
h. 
Subject has mental or neuromuscular disorder which would create an unacceptable risk 
of fixation failure or complications in post-operative care  
i. 
Subject has any other medical or surgical condition which would preclude the 
potential benefit of surgery 
Endpoints 
Primary Endpoint 
The primary endpoint of this clinical investigation is to confirm efficacy/performance at 12 
months, as measured by the SF-36 Physical Component Summary (PCS). Confirmation of 
efficacy/performance at 12 months will be based on an equal or higher (non-inferior) SF-36 
Physical Component Summary (PCS) result of the T2 Alpha Tibia Nailing System compared 
to the T2 Tibia benchmark literature (Wang, et al. 2017; Sanders, et al. 2014; Sun, et al. 
2016; Chan, et al. 2016). 
Secondary Endpoints  
 
Safety: Incidence of device-related adverse events will be monitored by 12 months 
through data collection and analyses. 
 
Efficacy/Performance: Bone consolidation will be assessed by 12 months as 
measured by Investigator assessment. 
 
3. General Information and Administrative Structure 
3.1. 
SPONSOR 
Stryker Orthopaedics 
325 Corporate Drive 
Mahwah, NJ 07430 
3.2. 
KEY SPONSOR PERSONNEL 
Susanne Höfer 
Clinical Study Manager 
Role: Author and Clinical Investigation Manager 
Email: Susanne.hoefer@stryker.com 
Phone: +49 175 1101616 

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Rebecca Gibson 
Manager, Clinical Research 
Role: Clinical Research Head 
Dr. Thomas Demuth, M.D. 
Medical Affairs Director 
Role: Medical Expert 
3.3. 
EDC SYSTEM  
Name: IBM Clinical Development 
Email: icdhelp@us.ibm.com 
Phone: +1 888 500 4247  
4. Product Information 
All components of the T2 Alpha Tibia Nailing System were cleared and approved for sale and use prior 
to starting the clinical investigation. 510(k) clearance was received on 06Jun2018. This system is to be 
used only for indications for which it has been approved. Please see the approved Instructions for Use 
and Operative Technique manuals for a detailed description of the medical device(s) and instrumentation, 
and intended use information. 
Medical device product traceability will be achieved by capturing the implant lot number. 
5. Risks and Benefits 
This prospective, multi-center, clinical investigation is designed to examine the safety and 
efficacy/performance of the T2 Alpha Tibia Nailing System, in accordance with the approved instructions 
for use, labeling and instrumentation. The potential risks to subjects are described in the approved 
Instructions for Use and Operative Technique manuals. 
Potential benefits resulting from the T2 Alpha Tibia Nailing System over other devices and procedures, 
as demonstrated by superior scoring on outcome surveys and positive results on other clinical evaluation 
measurements (outlined in section 8), would also suggest affirmative clinical efficacy.  
6. Introduction 
The T2 Tibia Nailing System represented the latest and most comprehensive development of the original 
intramedullary principles presented by Professor Gerhard Kuentscher in 1940. As an addition to the T2 
Nailing System, Stryker has created a new generation tibial implant that offers an efficient treatment 
option for multiple indications. The T2 Alpha Tibia Nail includes new locking options and the ability to 
utilize the advanced locking screw which creates an axial and angular stable construct. New 
instrumentation offers a combination of innovation, simplicity and efficiency that is designed to suit the 
various needs of surgeons and OR staff.  
7. Clinical Investigation Design 
This investigation is a prospective, multicenter clinical investigation. It is anticipated that a total of 80 
subjects will be enrolled at up to 5 sites. Enrollment is estimated to commence in Q4 of 2018. Neither 

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subjects nor investigators are blinded to treatment and the clinical investigation includes a historical 
control which will be compared to the T2 Alpha Tibia Nailing System.  
The enrollment period is expected to occur over32 months. Total duration of enrollment, 12 month 
follow-up and analysis is expected to take 47 months. The clinical investigation has been designed to 
, in addition to a 12 month follow-up 
visit. 
7.1. 
CLINICAL INVESTIGATION RATIONALE 
The T2 Alpha Tibia Nailing System is fully integrated into the T2 Alpha Platform. The system includes 
two approaches: infrapatellar approach and suprapatellar approach and allows for multiple locking 
configurations for stable fixation. This clinical investigation will evaluate the safety and 
efficacy/performance of the T2 Alpha Tibia Nailing System. 
8. Objective 
8.1. 
PRIMARY ENDPOINT 
The primary endpoint of this clinical investigation is to confirm efficacy/performance at 12 months, as 
measured by the SF-36 Physical Component Summary (PCS). Confirmation of efficacy/performance at 
12 months will be based on an equal or higher (non-inferior) SF-36 Physical Component Summary (PCS) 
result of the T2 Alpha Tibia Nailing System compared to the benchmark literature (Wang, et al. 2017; 
Sanders, et al. 2014; Sun, et al. 2016; Chan, et al. 2016). 
8.2. 
SECONDARY ENDPOINTS 
 
Safety: Incidence of device-related adverse events by 12 months will be monitored through 
collection and analyses. 
 
Efficacy/Performance: Bone consolidation will be assessed by 12 months as measured by 
Investigator assessment.  
9. Selection of Clinical Investigation Population 
Subjects participating in this clinical investigation 
subject population, where all subjects presenting for treatment of tibial fractures will be evaluated for 
clinical investigation participation based on the eligibility criteria listed below. 
9.1. 
INCLUSION CRITERIA 
a. Subject is a male or non-pregnant female age 18 years or older at the time of surgery; 
b. Subject is willing and able to give written informed consent and comply with the requirements 
of this Clinical Investigation Plan; 
c. Subject is intended to be, treated with the Tibial Nail of the T2 Alpha Tibia Nailing System in 
accordance with the following legally cleared/ approved Indications for Use: 
Indications for Use approved In United States and Canada include: 
 
Open and closed tibial fractures 
 
Pseudoarthrosis and correction osteotomy 
 
Pathologic fractures, impending pathologic fractures and tumor resections 
 
Fractures involving osteopenic and osteoporotic bone 

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Nonunions and malunions 
 
Indications for Use approved In Europe and Other Countries include: 
 
Open and closed tibial fractures 
 
Nonunions and malunions 
9.2. 
EXCLUSION CRITERIA 
a. Subject has an active or suspected latent infection or marked local inflammation in or about the 
affected area 
b. Subject has compromised vascularity that would inhibit adequate blood supply to the fracture or 
the operative site 
c. Subject has documented bone stock compromised by disease, infection or prior implantation 
which cannot provide adequate support and / or fixation of the device 
d. Subject has documented or suspected sensitivity to materials    
e. Subject is obese such that he / she produces a load on the implant which can lead to failure of 
fixation of the device or to failure of the device itself 
f. Subject has inadequate tissue coverage over the operative site. 
g. Subject has implant utilization that would interfere with anatomical structures or physiological 
performance 
h. Subject has mental or neuromuscular disorder which would create an unacceptable risk of 
fixation failure or complications in post-operative care  
i. 
Subject has any other medical or surgical condition which would preclude the potential benefit 
of surgery  
9.3. 
WITHDRAWAL CRITERIA 
If, during the clinical investigation, a subject must be prematurely withdrawn, the procedures outlined in 
this section must be followed. These procedures should not interfere with the initiation of any new 
documented.  
Subjects may be withdrawn from the clinical investigation for any of the following reasons:  
a. Subject Withdrawal: A subject may voluntarily withdraw from the clinical investigation at any 
time and for any reason. The subject should be asked when possible, and without any form of 
coercion, the reason for his/her decision. If the participant withdraws from the clinical 
investigation completely, then data collected up until the point of withdrawal will be included in 
the final analysis. Subjects who decline to continue to take part will be given the opportunity to 
discuss/inform the research team of the reasoning behind their decision not to take part. 
b. Lost to Follow-Up (LTFU): A subject will be considered LTFU after all reasonable efforts have 
been made to contact the subject and request his/her continued participation in the clinical 
investigation. All attempts to contact the subject must be documented and should include at least 
two attempts to contact the subject by phone and one attempt via a certified letter. Data collected 
up until the point where the subject is LTFU will be included in the final analysis. 
c. Removal of Device or Adverse Event/Incident
in the clinical investigation due to the removal of the Tibial Nail of the T2 Alpha Tibia Nailing 
System or Adverse Event/incident that prohibits his/her continued participation must be fully 
explained. All available information concerning the removal of the device or Adverse 

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Event/incident should be provided. Data collected up until the point of removal or Adverse 
Event/incident will be included in the final analysis. 
d. Death: The discontinuation 
must be fully explained. All available information concerning the death should be provided. 
Removal of a subject from continued follow-up in the clinical investigation due to death will not 
be considered a device failure unless the death is directly caused by, or attributable to, the T2 
Tibia Nailing System. Data collected up until the point of death will be included in the final 
analysis. 
e. Other: A subject may be withdrawn by the Investigator if he/she believes that it is in the best 
the clinical investigation represents an unacceptable risk to the subject. The Sponsor must be 
notified immediately if this occurs. All data collected up until the point of withdrawal or IRB/EC 
determination will be included in the final analysis. 
A subject may also be withdrawn if the subject is non-compliant with the clinical investigation 
procedures or visits, or if a selection criteria violation is noted after the subject received the 
clinical investigation treatment and it is determined that the subject should be discontinued. All 
data collected up until the point of withdrawal will be included in the final analysis. 
10. Clinical Investigation Evaluations, Procedures and Assessments 
10.1. METHODS OF ASSIGNING SUBJECTS 
No specific methods (e.g. randomization, blinding, or stratification) for assigning subjects are used in 
this Clinical Investigation Plan. Consecutive subjects at each site meeting all the eligibility criteria will 
be enrolled in this clinical investigation. 
10.2. PROCEDURES 
Subjects recruited to this clinical investigation have received the Tibial Nail of the T2 Alpha Tibia 
Nailing System. Please see the approved Instructions for Use and Operative Technique Manuals for a 
detailed description of the medical device(s) and instrumentation, intended use information and 
associated risk. Any additional clinically indicated procedures are permitted as deemed necessary by the 
clinical investigation investigator. 
10.3. INITIAL ASSESSMENT 
All subjects presenting for treatment of femoral fractures at the investigative sites will be evaluated for 
clinical investigation participation based on the eligibility criteria listed in Section 9. Informed consent 
will be obtained from each subject before any study procedures are performed.  Details on obtaining 
informed consent and related documentation are provided in Section 15.2.  
The initial assessment may occur prior to the index surgery, 
the 3 months post-
SF-36 PCS and MCS  
 will 
be 
-operative health status.  
 
10.4. FOLLOW-UP EVALUATIONS 
The follow-up evaluations will occur at 3 Months, 6 Months and 12 Months after the index procedure 
and include an assessment of device-related adverse events/incidents, evaluation using the SF-36 PCS 
and MCS scores, as well as clinical assessment of bone consolidation. Investigators should consider 
weight-bearing, pain and imaging when assessing bone consolidation. See the section below for visit 
windows and a list of assessments to be performed at each visit.  

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Investigative site personnel will contact subjects prior to their scheduled follow-up evaluations to 
encourage compliance with clinical investigation visits and participation. 
If a subject misses a visit and is outside of the visit window, every effort should be made to collect data 
instead of noting the visit as missed. 
10.5. SCHEDULE OF EVENTS 
Assessment 
 
Initial 
Assessment 
3 Months a, b 
(+/-2 weeks) 
6 Months a, b 
(+/-3 weeks) 
12 Months b  
(+/-4 weeks) 
Informed Consent 
 
Xc 
  
  
  
Demographics & Medical History 
 
X 
  
  
  
Inclusion/Exclusion 
 
X 
  
  
  
Primary Diagnosis 
 
X 
  
  
  
Surgical Procedure  
X 
  
  
  
Clinical Assessment of Bone  
Consolidation d, e  
  
X 
X 
X 
SF-36v2 (PCS & MCS) 
 
 X f  
X 
X g 
X g 
Subject Disposition h 
  
X 
X 
X 
Device-Related Adverse Events/Incidents & Reoperations will be collected throughout the course of the Clinical 
Investigation. 
a. 
Follow-up v
of Care practices 
b. If the subject missed a visit and outside of visit window, every effort should be made to collect data instead of noting 
visit as missed. Visit windows are calculated from the index event, and not from the previous visit.  
c. 
Informed consent must be obtained prior to enrollment in the study (i.e., prior to performance of any study-related 
activities).  
d. Once bone consolidation is observed, assessment no longer needs to be conducted at the additional follow-up visits.  
e. 
Investigators should consider weight-bearing, pain and imaging when assessing bone consolidation. 
f. 
SF-36v2 evaluation must be collected post-informed consent.  
g. If bone consolidation is previously observed at the previous follow-up visit, evaluation is to be collected via phone. 
h. Subject Disposition assessment would occur at any time point for subject withdrawal prior to the completion of the 
clinical investigation. 
 
 

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11. Statistical Methods
The Statistical Analysis Plan (SAP) lists all variables/questions within this clinical investigation. 
 
Data will be captured via IBM Merge EDC system and statistical analysis will be performed using IBM 
SPSS. All statistical hypotheses tests will be with confidence levels (1-
-
-
-
will indicate statistical significance. 
Results will be presented using summary tables and optionally supported by graphs. For detailed 
information per variable, see SAP. 
11.1. DETERMINATION OF SAMPLE SIZE 
The 12 months post-operative results for subjects implanted with the Tibial Nail of the T2 Alpha Tibia 
Nailing System will be compared to a historical group and results reported by Wang, et al. (2017); 
Sanders, et al. (2014); Sun, et al. (2016); and Chan, et al. (2016) will serve as the control group for the 
T2 Alpha Tibia Nail subjects. 
Hypotheses were developed to allow for a comparison of 12 months post-operative SF-36 Physical 
Component Summary (PCS) results and 12 months effectiveness/performance between these two 
populations. 
Benchmark and Objectives for Planned Research 
Endpoint 
Non-inferiority related to the SF-36 Physical Component Summary (PCS) for subjects 
undergoing infrapatellar (IP) and/or suprapatellar (SP) tibia nailing at 12 months post-
operative compared to the pooled literature control. 
Estimated drop-
out rate 
20% 
Femur. A Prospective Randomized Comparison of Piriformis Fossa and Greater 
 
Stannard et al. reported a lost to follow up rate of 19.6% (11/56). 
Note: The source of Stannard et al. was used for T2 Alpha Tibia as well as it represents a 
worst-case drop-out rate. 
Results as reported by Benchmark 
Non-inferiority related to the SF-36 Physical Component Summary (PCS) for subjects undergoing infrapatellar 
(IP) or suprapatellar (SP) tibia nailing at 12 months post-operative.  
The results from the sources Chan et al, Sanders et al., and Sun et al. were pooled to determine overall two-sided 
90% confidence intervals of the mean SF-36 PCS (physical) and mean SF-36 MCS (mental) scores.  
Note: The results reported by Wang et al. seemed to be based on a different calculation method for the determination of the SF-36 scores and 
it was not possible to evaluate, what exactly was done by the authors. The score values reported by Wang et al. are much higher compared to 
what was normally reported in the literature and what was defined in country specific weights and coefficients. Wang et al. reported median 
score values whereas the other authors reported means. As summary score results usually tend to deviate from normality, means and medians 
might differ significantly. Therefore, the results reported by Wang et al. were not included into the pooled analysis. 
Source 
Subgroup 
Mean SF36-
PCS 
Mean SF36-
MCS 
Pooling 
Chan et al. 
IP 
38.00 
47.00 
included 
Chan et al. 
SP 
46.00 
47.00 
included 
Sanders et al. 
SP 
40.80 
46.00 
included 
Sun et.al. 
SP 
49.41 
44.71 
included 
Sun et.al. 
IP 
43.21 
43.81 
included 
Wang et.al. 
  
79.10 
77.00 
excluded 
Summary of explorative analysis is listed below: 

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As the mean physical score (PCS) was slightly lower, it was used for the sample size calculation. 
For the clinical investigation the one-sided 95% confidence interval will be applied.  
Acceptance Criteria for Sample Size Calculation 
 
0.05 (5%) 
Power (1-
 
0.80 (80%) 
Confidence Interval (CI) 
0.95 (95%) 
Tails 
1 
Path 
Non-inferiority 
 
Hypotheses Pair 
Null (H0) 
A  B < -  
Alternative (H1) 
A  
-  
Benchmark Timepoint 
12 months post-operative 
Benchmark Mean 
43.48 points SF-36 PCS at 12 months (IP and SP together) 
Benchmark Std. Dev. 
No standard deviation results were given by Chan et al., Sanders et al. nor by 
Wang et al. 
 
Only Sun et al. reported standard deviations at 12 months postoperative for 
SF-36 PCS of 6.27 for the SP and of 6.52 for the IP subgroup 
As a worst-case, the double standard deviation reported by Sun et al. was used 
for the sample size calculation (2 * 6.52 = 13.04 points) 
Benchmark 90% CI of Mean
Lower 90% CI: 39.25 (two-sided 90% CI equals a one-sided 95% CI) 
Upper 90% CI: 47.72 
Margin (-
 
Lower 90% CI of Benchmark: 39.25 
Software Used 
IBM SPSS Sample Power V3.0 
IBM SPSS Sample Power Output 
One goal of the proposed clinical investigation is to test the null hypothesis that the population mean is 39.25. 
The criterion for significance (alpha) has been set at 0.050. The test is 1-tailed, which means that only an effect 
in the expected direction will be interpreted. 
With the proposed sample size of 61 subjects, the clinical investigation will have power of 80.0% to yield a 
statistically significant result. 
This computation assumes that the population from which the sample will be drawn has a mean of 43.48 with a 
standard deviation of 13.04. The observed value will be tested against a theoretical value (constant) of 39.25. 
This effect was selected as the smallest effect that would be important to detect, in the sense that any smaller 
effect would not be of clinical or substantive significance. 

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A second goal of this clinical investigation is to estimate the mean in the population. On average, a clinical 
investigation of this design would enable us to report the mean with a precision (95.0% confidence level) of 
plus/minus 2.77 points.  
The precision estimated here is the median precision. Precision will vary as a function of the observed standard 
deviation (as well as sample size), and in any single clinical investigation will be narrower or wider than this 
estimate. 
IBM SPSS Sample Power Output  Screenshot 
 
Estimated drop-out rate is 20% which leads to the requirement of enrolling additional 13 subjects into the 
clinical investigation. 
Sample Size 
Overall number of subjects to be enrolled: 74 subjects (rounded up to 80 
subjects) 
11.2. ANALYSIS POPULATIONS 
It is expected, that during this clinical investigation only one population for T2 Alpha Tibia will exist 
and 
er P
subjects might need to be excluded from the PP population. In this occasion, there will be two groups 
being fully analyzed to ensure transparency and avoid bias.  
The groups are defined as follows: 
 
Intent-to Treat Population 
The Intent-to-Treat (ITT) Population is defined to be all enrolled subjects. An enrolled subject is a 
subject that has signed informed consent, all screening procedures have been successfully completed, 
is eligible and can receive treatment. The ITT population will not be analyzed for the annual reports 
and will only be included in the final report. 
 
Per Protocol Population 
The Per Protocol (PP) Population is defined to be all subjects in the ITT Population with no major 
protocol violations. The protocol violations that will exclude a subject are as follows: 
 
The subject does not receive the Tibial Nail of the T2 Alpha Tibia Nailing System 

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The subject does not meet all eligibility criteria 
 
The subject has a protocol violation that is considered likely to affect subject outcomes. 
After the clinical investigation has been completed, a review of the data will be conducted to 
determine which subjects are to be excluded from the PP population. 
11.3. ANALYSIS PLAN BY CLINICAL INVESTIGATION ELEMENT AND EVALUATION 
11.3.1. Statistical Analysis 
Evaluation elements are defined as the questions on the CRF/eCRF. The SAP lists all evaluation 
elements and secondary elements which will be based on calculations between two or more 
evaluation elements.  
All quantitative variables, including those based on calculations (secondary elements), will be 
analyzed with a case summary evaluation before the detailed characteristics and parameter can 
be evaluated. A case summary contains a listing of the number of valid cases/values, missing 
cases/values (if any) and total cases/values in the specific analysis. In general, as central position 
parameter for quantitative variables the mean, median and mode will be analyzed. As variation 
parameter the standard deviation, 95% confidence interval of the mean, interquartile range and 
range (based on maximum and minimum) will be calculated. All quantitative variables will be 
assessed for normality used the Shapiro-Wilk test. For optional visualization of quantitative 
variables, box-and-whisker plots will be used. Additional analyses like skewness and kurtosis 
measures of standard errors are also optional. 
All qualitative variables, including those based on summaries (secondary elements), will be 
analyzed listing the proportions, frequencies, column and row totals and missing proportion (if 
any). 
The SAP reflects this approach and specifies the variables characteristics (quantitative or 
qualitative) in detail together with the related analysis strategy. This also includes calculation 
and summaries based on primary elements and the required analysis. 
11.3.2. Primary Analysis / Endpoint 
This analysis is only part of the final report. The primary endpoint analysis will only be executed 
once at the end of the clinical investigation and will not be part of any interim or annual reports 
or presentations given in front of the final report. 
The 12 months post-operative results for subjects implanted with the T2 Alpha Tibia Nailing 
System will be compared to Sanders et al: Semiextended intramedullary nailing of the tibia 
using a suprapatellar approach: radiographic results and clinical outcomes at a minimum of 12 
months follow-up. J Orthop Trauma, 2014; Sun et al: The outcome comparison of the 
suprapatellar approach and infrapatellar approach for tibia intramedullary nailing. Int Orthop, 
2016; and Chan et al: Suprapatellar Versus Infrapatellar Tibial Nail Insertion: A Prospective 
Randomized Control Pilot Study. J Orthop Trauma, 2016
Specifically, the SF-36 score results 
reported by Wang, et al. (2017), Sanders, et al. (2014), Sun, et al. (2016) and Chan, et al. (2016) 
will serve as the control groups for the T2 Alpha Tibia group. 
Higher SF-36 PCS and MCS score results are linked to better subject results and vice versa. 
The clinical investigation endpoint is non-inferiority to the control, meaning the clinical 
investigation result should be equal or better than the control. In this clinical investigation, an 
equal or better SF-36 score result means equal or greater 
. As only results from samples will 
be captured, results are mostly estimates of the true population parameter. These estimates vary 
by a certain area, where it is expected that the true population parameter falls within. Based on 
this, it is required to specify a lower limit for the acceptable difference or zone of indifference, 
denoted as -  

T2 Alpha Tibia CIP  Version 3 
 
Page 16 of 25  
Hypotheses were developed to allow for a comparison of the 12 months post-operative SF-36 
PCS to evaluate effectiveness / performance. The 12 months post-operative SF-36 PCS is the 
primary endpoint of this clinical investigation. Hypothesis tests will be one-sided with a 
 
Hypothesis 
Equations 
Interpretation 
Null (H0) 
 
Central tendency of A is inferior to 
the central tendency of B. 
T2 Alpha Tibia (A)  Control (B, 
pooled benchmark results) 
 
Alternative 
(H1) 
 
Central tendency of A is non-inferior 
to the central tendency of B. 
T2 Alpha Tibia (A)  Control (B, 
pooled benchmark results) 
 
 
Possible  
Evidence (p) 
Possible 
Decisions 
Possible Conclusions  SF-36 PCS 
 
Fail to reject 
null hypothesis 
(H0) 
T2 Alpha Tibia < Control (pooled benchmark 
results) 
Insufficient evidence to reject the null hypothesis 
(H0: 
) at the pre-determined significance 
level of 5%.  
 
Reject null 
hypothesis (H1) 
 Control (pooled benchmark 
results) 
Sufficient evidence to reject the null hypothesis 
(H0: 
) at the pre-determined significance 
level of 5%.  
To test non-inferiority, the 12 months mean SF-36 PCS result of the T2 Alpha Tibia group will 
be compared to the mean estimate of the control group, 43.48 points.  
To be able to identify an acceptable difference or zone of indifference (- , the lower 90% 
confidence interval (CI) of the SF-36 PCS result at 12 months post-operative in the control 
group (Sanders, et al.; Sun, et al.; Chan, et al.) was used as lower limit (lower 90% CI of control 
is 39.25 points). The maximum acceptable difference in the negative direction is 4.23 points. 
Based on the underlying distribution of the data and the result of the normality assessment, 
either the parametric one-sample t-test or the non-parametric one-sample sign test will be used 
to compare the 12 months post-operative SF-36 PCS result of the T2 Alpha Tibia group against 
the value of 39.25 points (mean of control -  or 43.48  4.23 = 39.25 points). 
 

T2 Alpha Tibia CIP  Version 3 
 
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11.3.3. Secondary Analyses 
For efficacy/performance, bone consolidation will be assessed by 12 months as measured by 
Investigator assessment. For Safety, the incidence of device-related adverse events/incidents by 
12 months will be monitored through collection and analyses. Both analyses will be part of the 
annual and final reports. 
Furthermore, device related adverse events/incidents and the time to (earliest) Device Related 
Adverse Events/incidents will be analyzed as well. Considered variables, the level of 
measurement and the planned analysis steps are listed in detail in the SAP. 
11.3.4. Additional Analyses 
Additional Analyses are outlined in the subsequent sections. Analysis details (variables, level 
of measurement, planned steps) are listed in-depth in the SAP. 
o Weight-bearing status 
The weight bearing status will be evaluated and analyzed at the pre-operative visit and 
at 3 months, 6 months and 12 months. The within subject changes from visit to visit will 
be analyzed in addition. This analysis will be part of the annual and final reports. 
o External Support 
The status of the subject using external support will be evaluated at the pre-operative 
visit and at 3 months, 6 months and 12 months. The within subject changes from visit 
to visit will be analyzed in addition. This analysis will be part of the annual and final 
reports. 
o Mortality 
For analysis of the time to death or mortality, the Kaplan-Meier method will be used. 
The times between the date of surgery and the date of the 12 months assessment will be 
used together with the times between surgery and the date of death. This analysis will 
be part of the annual and final reports. 
o Reoperation 
For analysis of the time to the reoperation, the Kaplan-Meier method will be used. The 
times between the date of surgery and the date of the 12 months assessment will be used 
together with the times between date of surgery and the date of reoperation (earliest 
reoperation in case that one subject experienced more than one reoperation). This 
analysis will be part of the annual and final reports. 
o SF-36 Total Score  Within subject changes by visit 
The within subject score changes of the SF-36 Total Score from visit to visit will be 
analyzed to help identify the changes on the subject level. This analysis will be part of 
the annual and final reports.  
11.4. MISSING DATA / SAP DEVIATIONS 
The intent is to collect as complete a dataset as possible. Nevertheless, in some situations missing 
data cannot be avoided. The reports and tables therefore will show the number and percentage 
of missing cases for each analyzed variable in relation to the enrolled cases for each post-
operative assessment 
Any deviations from Statistical Analysis Plan will be listed in the annual or final reports.  

T2 Alpha Tibia CIP  Version 3 
 
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11.5.
REPORTS
11.5.1. Interim Analysis and Reports 
Interim analyses will be performed on a yearly basis. The progress of the clinical investigation 
will be reported together with the interim results on the variable level according to the analysis 
plan. The only exception is the analysis of the primary endpoint will not be part of the interim 
reports.  
11.5.2. Final Analysis and Reports 
The full final report with complete analysis and progress and conduct reporting will be created 
at the end of this clinical investigation. 
12. Clinical Investigation Plan Deviations 
A Clinical Investigation Plan (CIP) deviation is a departure from the approved CIP that is not 
implemented or intended as a systemic change. All CIP deviations are recorded and reported to each 
/EC 
/EC policies. 
13. Adverse Events/Incidents 
As this CIP is being carried out to satisfy the post-market requirements to support safety and 
efficacy/performance according to the Council Directive 93/42/EEC concerning medical devices (Annex 
X (1.1c)) (MDD 93/42/EEC) and Regulation 2017/745 on medical (MDR 2017/745), categorization and 
definition of device related adverse events will follow the guidelines outlined in the MDR 2017/745 as 
The following AE terminology will apply: 
An Adverse Device Effect (ADE) is defined as any untoward or unintended response to the 
clinical investigation treatment; and/or a medical response which may have a causal relationship 
to the treatment. 
 
An Incident is defined as any malfunction or deterioration in the characteristics or performance of a 
device made available on the market, including use-error due to ergonomic features, as well as any 
inadequacy in the information supplied by the manufacturer and any undesirable side-effect. 
 
A Serious Adverse Device Effect (SADE) is defined as any ADE that results in consequences 
characteristic of a SAE or might lead to the consequences if suitable action or intervention is not 
or life-
required intervention to prevent disability or permanent damage; results in a life-threatening illness 
or injury; and/or results in death (fatal). 
 
A Serious Incident is defined as any incident that directly or indirectly led, might have led or might 
lead to any of the following: 
o the death of a patient, user or other person;  
o the temporary or permanent serious deterioration of a patient's, user's or other person's 
state of health;  
o a serious public health threat 
 
An Unanticipated Adverse Device Effect (UADE) is defined as an Adverse Event not described in 
the informed consent, Clinical Investigation Plan or device labeling which has resulted in any of the 

T2 Alpha Tibia CIP  Version 3 
 
Page 19 of 25  
consequences of a SAE or which might have led to any of the consequences of a SAE if suitable 
action had not been taken, intervention had not occurred, or if circumstances had been less opportune. 
Anticipated Adverse Events will be those listed in the T2 Alpha Tibia Nailing System device labeling 
(Operative Technical Manual and Instructions for Use). 
13.1. ADVERSE EVENT/INCIDENT SEVERITY 
The severity of all AEs/incidents is assessed by the Investigator utilizing the following categories: 
 
Mild: The AE/incident is transient and easily tolerated by the subject. 
 
Moderate: The AE/incident 
activities. 
 
Severe: The AE/incident 
be incapacitating or life-
permanent damage, and/or required intervention to prevent permanent disability or damage. 
 
Life-threatening: The AE/incident results in a life-threatening illness or injury. 
 
Fatal: The AE/incident results in death. 
13.2. RELATIONSHIP TO THE DEVICE 
Only adverse events/incidents that are considered possibly, probably or definitely related to the device 
will be captured for this clinical investigation. 
13.3. FORESEEABLE ADE AND SADE 
ADEs, SADEs and incidents which may be expected as part of the surgical interventions include: 
 
Axial malalignment 
 
Chondromalacia 
 
Compartment syndrome 
 
Deep vein thrombosis 
 
Delayed union 
 
Fat embolism 
 
Hematoma 
 
Iatrogenic fracture 
 
Implant breakage (nail) 
 
Implant breakage (screw) 
 
Implant failure (nail) 
 
Implant failure (screw) 
 
Implant loosening (nail) 
 
Implant loosening (screw) 
 
Infection (deep) 
 
Infection (superficial) 
 
Malunion 

T2 Alpha Tibia CIP  Version 3 
 
Page 20 of 25  
 
Necrosis 
 
Non-union 
 
Pain 
 
Peripheral nerve injury without specification 
 
Pressure ulcer 
 
Pre-tibial fistula 
 
Pulmonary embolism 
 
Rotational malalignment 
13.4. ADVERSE DEVICE EFFECT/INCIDENT REPORTING AND ANALYSIS 
In the event that a SADE, UADE or serious incident occurs, the Investigator is required to notify the 
Sponsor within 48 hours of being made aware of the event. The Investigator is also required to notify 
their IRB/EC in accordance with the policies of their local laws and regulations. 
14.  Reoperations 
Reoperations and reason(s) for reoperations will be collected throughout the course of the clinical 
investigation. A reoperation may include, but not limited to, irrigation and debridement, revision surgery, 
and/or implant removal. 
15. Ethics 
This clinical investigation is to be conducted according to International Conference of Harmonisation of 
Good Clinical Practice (ICH-GCP), applicable regulations, institutional research policies and procedures, 
Declaration of Helsinki and in compliance with the Clinical Investigation Plan (CIP). Investigators will 
be trained on the clinical investigation devices and surgical techniques prior to implanting clinical 
investigation subjects. 
This CIP and any amendments will be submitted to a properly constituted independent ethics board, in 
agreement with local legal prescriptions, for formal approval of the clinical investigation conduct. The 
decision of the ethics board concerning the conduct of the clinical investigation will be made in writing 
to the Site Principal Investigator before commencement of this clinical investigation. Clinical 
investigations shall not begin until the governing regulatory authority has provided full, unconditional 
approval. Off-label use of the T2 Alpha Tibia Nailing System is not permitted. 
15.1. INSTITUTIONAL REVIEW BOARD (IRB)/ETHICS COMMITTEE (EC) 
IRB/EC approval will be obtained at each of the investigational sites prior to enrolling clinical 
investigation subjects at that site. In addition, any SADE, UADE or serious incident that meets the 
reporting criteria of the IRB/EC, will be reported to the IRB/EC. During the clinical investigation, the 
Investigator should promptly provide written reports to the IRB/EC of any changes that affect the conduct 
of the clinical investigation and/or increase risk to the subjects, unless otherwise submitted by the 
Sponsor. 
15.2. INFORMED CONSENT 
The Investigator, or qualified clinical investigation personnel designated to perform this task, will explain 
the nature of the clinical investigation to the subject, and answer all questions regarding participation in 
this clinical investigation. Prior to any clinical investigation procedures being performed, the ICF will be 
reviewed, signed and dated by the subject, and by the person administering the informed consent. A copy 

T2 Alpha Tibia CIP  Version 3 
 
Page 21 of 25  
of the ICF will be given to the subject, and the original
clinical investigation
/EC 
during the course of the clinical investigation. 
16. Data Collection Process 
The Sponsor will collect clinical data for this clinical investigation utilizing eCRFs through an EDC 
system. All clinical data is entered into the EDC system by designated personnel at each of the 
Investigator sites. All data entered in the eCRFs are supported by source documentation.  
17. Clinical Investigation Monitoring 
It is the responsibility of the Site Principal Investigator to oversee the safety of the clinical investigation 
at his/her site, to include the careful assessment and appropriate reporting of AEs/incidents as noted 
above as well as the implementation of site data safety. The Sponsor, or designee, will monitor the sites 
to ensure informed consent has been documented appropriately, to ensure the information documented 
on the completed case report forms match the medical records and to resolve any differences. The 
Sponsor will take all steps necessary to ensure data integrity. The Sponsor will also review significant 
new information, including unanticipated adverse device effects/incidents and ensure that such 
information is provided to all Investigators, their IRBs/ECs, and applicable regulatory authorities. 
Additionally, a quality assurance check will be performed to ensure the investigator is complying with 
the Clinical Investigation Plan and applicable regulations in the collection of all clinical investigation 
data. 
18. Data Handling and Record Keeping 
Information about clinical investigation subjects will be kept confidential. In the event a subject revokes 
authorization to collect or use protected health information, the Site Investigator, by regulation, retains 
the ability to use all information collected prior to the revocation of subject authorization. The Health 
Insurance Portability and accountability Act (HIPAA) will apply in order to ensure data protection and 
document anonymization. Records are to be stored in a secure location. Retention of records shall be 
maintained through the clinical investigation duration as well as specified years following the clinical 
investigation completion as required by local regulatory authority. 
19. Reports 
Analysis will be executed and interim reports will be prepared on a yearly basis. Upon the completion of 
all subjects final post-operative assessment, data freeze will take place and the final report will be 
prepared.  
20. Public Registration 
The clinical investigation and summary of results will be registered on ClinicalTrials.gov and/or 
European Database on Medical Device (EUDAMED).  
21. Completion of the Clinical Investigation 
The Investigator will conduct this clinical investigation in compliance with the Clinical Investigation 
Plan, and will complete the clinical investigation within the timeframe specified in the contract. 

T2 Alpha Tibia CIP  Version 3 
 
Page 22 of 25  
Continuation of the clinical investigation beyond this time must be mutually agreed upon in writing by 
both the Investigator and Stryker. The Investigator will provide a summary of the clinical investigation 
results in accordance with the IRB/EC guidelines. 
Stryker may terminate this clinical investigation prematurely, either in its entirety or at this site, for 
reasonable cause provided that written notice is submitted a reasonable time in advance of the intended 
termination. The Investigator may also terminate the clinical investigation at their site for reasonable 
cause, after providing written notice to Stryker a reasonable time in advance of the intended termination. 
If Stryker terminates the clinical investigation for safety reasons, it will immediately notify the 
Investigator by telephone and subsequently provide written instructions for clinical investigation 
termination. 
22. Essential Documents 
All essential documentation will be stored as specified under the S
perating 
Procedures. 
23. Publication Policy 
Refer to the clinical investigation agreement for the publication policy. 
24. References 
Chan DS, Serrano-Riera R, Griffing R, Steverson B, Infante A, Watson D, Sagi HC, Sanders RW. 
Suprapatellar Versus Infrapatellar Tibial Nail Insertion: A Prospective Randomized Control Pilot Study. 
J Orthop Trauma. 2016; 30(3):130-4. 
Sanders RW, DiPasquale TG, Jordan CJ, Arrington JA, Sagi HC. Semiextended intramedullary nailing 
of the tibia using a suprapatellar approach: radiographic results and clinical outcomes at a minimum of 
12 months follow-up. J Orthop Trauma. 2014; 28(5):245-55. 
Stannard JP, Bankston L, Futch LA, McGwin G, Volgas DA. Functional Outcome Following 
Intramedullary Nailing of the Femur. A Prospective Randomized Comparison of Piriformis Fossa and 
Greater Trochanteric Entry Portals. JBJS. 2011; 93: 1385-91. 
Stryker Trauma GmbH. Instructions for Use T2 Alpha Tibia Nailing System. [L22000044 Rev. AA, 03-
2018]. 
Stryker Trauma GmbH. Instructions for Use IMN Instruments. [L22000035 Rev. AB, 11-2017]. 
Stryker Trauma GmbH. Instructions for Use IMN Screws System. [L22000045 Rev. AA, 03-2018]. 
Sun Q, Nie X, Gong J, Wu J, Li R, Ge W, Cai M. The outcome comparison of the suprapatellar 
approach and infrapatellar approach for tibia intramedullary nailing. Int Orthop. 2016; 40(12):2611-
2617.  
Wang Z, Cheng Y, Xin D, Liu T, Qu W, Wang D, Zhao Y, Zhao J. Expert Tibial Nails for Treating 
Distal Tibial Fractures With Soft Tissue Damage: A Patient Series. J Foot Ankle Surg. 2017; 
56(6):1232-1235. 

T2 Alpha Tibia CIP  Version 3 
 
Page 23 of 25  
Ware JE Jr, Kosinski M, Gandek B. SF-36 Health Survey: manual and interpretation guide. Lincoln, 
RI: QualityMetric Inc. 2000; B6-B11. 
 
 

T2 Alpha Tibia CIP  Version 3 
 
Page 24 of 25  
25. Clinical Investigation Plan Signature Page
A Post-Market Clinical Evaluation of the Treatment of Tibia Fractures with the T2 Alpha Tibia Nailing 
System 
 
T2 Alpha 
 
 
I have read this Clinical Investigation Plan and agree that this clinical investigation is ethical. I agree to 
conduct this clinical investigation in accordance with this Clinical Investigation Plan, as well as all 
applicable regulations and guidelines. I agree to maintain the confidentiality of all information received 
or developed in connection with this Clinical Investigation Plan. 
 
 
 
 
 
Signature of Investigator  
 
Date of Signature 
 
 
 
 
 
Name of Investigator (Printed) 
 
 
 

T2 Alpha Tibia CIP  Version 3 
 
Page 25 of 25  
26. Document Version History
Version 
Effective Date 
Description 
Revised/Created by 
1 
27-Aug-2018 
Initial version 
Colleen Bordeaux 
2 
24-Jan-2020 
See tracked version for 
changes 
Christine Youssif 
3 
23-Nov-2020 
See tracked version for 
changes 
Susanne Höfer  
 

Certificate Of Completion
Envelope Id: 4059EB738D08410484D696B80A746CDB
Status: Completed
Subject: T2 Alpha Tibia_Protocol_version 3_23Nov2020
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Susanne Höfer
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