Evaluation of the Rotation Medical Bioinductive Implant for Insertional Achilles Tendinopathy
Phase: NA
Conditions: Tendinopathy
Sponsor: Smith & Nephew, Inc.

 
PROTOCOL STUDY SYNOPSIS 
Title: 
Evaluation of the Rotation Medical Bioinductive Implant for Insertional 
Achilles Tendonopathy 
Study Devices: 
Rotation Medical Bioinductive Implant 
(Cleared for commercial use by the U.S. Food and Drug Administration: 
K140300; K131637; K131635; K122048) 
Study Design: 
Prospective, non-randomized 
Enrollment: 
Up to 10 subjects will be treated  
Inclusion 
Criteria: 
1. At least 21 years of age 
2. Insertional Achilles tendonitis requiring surgery that has failed conservative 
management, which consist of: 
A. Shoe modification 
B. Nonsteroidal anti-inflammatory drugs 
C. Physical Therapy with/without modalities 
3. Chronic Achilles tendon pain lasting longer than 3 months  
4. MRI of the ankle within 60 days prior to the study procedure 
5. Willing to comply with the prescribed post-operative rehabilitation program 
6. Willing to be available for each protocol-required follow-up examination 
7. Able to understand the informed consent process, including regulatory 
requirements such as HIPAA authorization, and document informed consent 
prior to completion of any study-related procedures 
8. Ability to read, understand, and complete subject-reported outcomes in 
English 
Exclusion 
Criteria: 
1. Achilles tendon rupture 
2. Previous Achilles tendon surgery on the index ankle 
3. Genetic collagen disease 
4. History of auto-immune or immunodeficiency disorders 
5. History of chronic inflammatory disorders 
6. Oral steroid use in last 2 months or injectable steroid use in last 4 weeks 
7. History of heavy smoking (> 1 pack per day) within last 6 months 
8. Hypersensitivity to bovine-derived materials 
9. Hypersensitivity to Polylactic Acid (PLA) and Polyetheretherketone 
(PEEK) materials 
10. Metal implants, fillings, shrapnel, and/or screws 
11. Females of child-bearing potential who are pregnant or plan to become 
pregnant during the course of the study 
12. Currently involved in any injury litigation or worker’s compensation claims 
relating to the index ankle 
13. Enrolled, or plans to enroll, in another clinical trial during this study that 
would affect the outcomes of this study 
14. History of non-compliance with medical treatment, physical 
therapy/rehabilitation, or clinical study participation 
15. History of cognitive or mental health status that interferes with study 
participation 
Study 
Objective: 
To evaluate bioinduction of new tissue and tendon healing after implantation of 
the Rotation Medical Bioinductive Implant used as adjunct to surgical repair in 
the treatment of insertional Achilles tendonitis. 
Protocol Number: 3672-01 
Created: February 12, 2016

 
Primary 
Outcomes: 
MRI assessment of the following: 
1. Increase in tendon thickness 
2. Integration of induced tissue with the underlying tendon and maturation of 
the induced tissue  
3. Amount of defect fill-in and characteristics of both the filled-in tissue within 
the tendon  
4. Achilles tendon tear rate at surgical site 
Secondary 
Outcomes: 
1. Safety 
2. Procedure parameters 
3. Recovery 
4. Subject satisfaction 
Study 
Assessments 
Baseline 
Procedure 
Post-procedure follow-up: 3 months, 1 year, 2 years 
Sponsor: 
Rotation Medical, Inc. 
15350 25th Avenue North 
Plymouth MN 55447 
Data 
Management 
and 
Monitoring: 
Rotation Medical, Inc. 
15350 25th Avenue North 
Plymouth MN 55447 
Protocol Number: 3672-01 
Created: February 12, 2016

 
 
 
  
 
1 
INTRODUCTION & RATIONALE 
 
Chronic insertional Achilles tendinopathy is a common ailment in the general population. 
It is traditionally described as a phenomenon of overuse in both athletic and nonathletic 
individuals. Non-operative management usually consists of activity and shoe 
modifications, nonsteriodal anti-inflammatory medications (NSAIDs), and some form of 
physical therapy, which can be successful. In patients in whom conservative interventions 
fail, operative intervention is the next step. This intervention intails open detachment  and 
debridement of the diseased Achilles tendon, calcaneal osteotomy, and reattachment of the 
Achilles. Often the diseased Achilles debridement leaves the tendon compromised in terms 
of its integrity and the remaining tendon will need augementation with a tendon transfer 
using the flexor hallucis longus (FHL).  
The Rotation Medical Bioinductive Implant is a bioabsorbable device that provides a layer 
of collagen over injured tendons.  This device is indicated for the management and 
protection of tendon injuries in which there has been no substantial loss of tendon tissue 
and can be implanted during a the standard open treatment for insertional Achilles 
tendinopathy.  The device was first evaluated in a preclinical study of 23 sheep that was 
approved by the Colorado State University Institutional Animal Care and Use Committee.  
The device did not elicit an inflammatory response or a foreign body reaction.Histological 
analysis confirmed the device was completely absorbed after six months with integration 
of the new tendinous tissue to the underlying host tendon and a fibrocartilagenous transition 
zone at the tendon-to-bone insertion site.  Tendon thickness at the implant site increased 
by approximately 2.5 millimeters due to induction of new tendinous tissue and remained 
stable one year after surgery. 
The Rotation Medical Bioinductive Implant was further evaluated in a clinical study of 24 
subjects who underwent implantation of the device and completed a minimum of one year 
follow-up.  This study was approved by the Northern Sydney Central Coast Ethics 
Committee and registered in the Australian New Zealand Clinical Trials Registry 
[#ACTRN12611001082998].  The procedure was performed arthroscopically in 14 
subjects while the other 10 subjects underwent a mini-open procedure. The median implant 
time was 15 minutes and all subjects were successfully implanted with no intent-to-treat 
failures.  One patient experienced a return to pain 12 months after surgery that was 
associated with significant bursitis and an arthroscopic clean-up procedure was performed 
to debride the bursa.  Despite the bursal reaction in this patient, tendon healing and tissue 
induction were not compromised. 
Magnetic resonance imaging (MRI) at 3, 6, and 12 months after surgery provided evidence 
that the device consistently induced the formation of new, tendinous tissue that appeared 
well-integrated with each patient’s native tendon tissue and showed progressive maturation 
over time.  MRI observations were consistent with the histological results from prior sheep 
studies. Shoulder function and pain was also assessed at 3, 6 and 12 months after treatment 
using the ASES (American Shoulder and Elbow Surgery) and Constant (Constant-Murley) 
standard shoulder surveys.  All of the scores at 12 months were significantly improved 
from baseline (p < 0.05) and improvement was comparable to published literature. 
Protocol Number: 3672-01 
Created: February 12, 2016

 
 
 
  
2 
DEVICE DESCRIPTION 
2.1 
DEVICE DESCRIPTION 
There are three implantable components in the Rotation Medical Bioinductive Implant™ 
(Figure 1). 
Bioinductive implant:  The device is made from highly purified reconstituted collagen 
fibers derived from bovine tendon and manufactured for Rotation Medical, Inc. by 
Collagen Matrix, Inc. (Oakland, New Jersey, USA). It is contraindicated for use in patients 
with a history of hypersensitivity to bovine-derived materials and this is an exclusion 
criterion for study participation. The device is designed to completely absorb within six to 
12 months. 
Tendon staples:  The tendon staples are made from poly(L-lactide-co-D,L-lactide) in a 
molar ratio of 70% L-lactide to 30% D,L-lactide.  Polylactide materials have been used in 
a variety of medical devices, such as bone anchors, bone pins, screws, plates, and spinal 
fusion cages. The tendon staples are designed to completely absorb within approximately 
12 months. 
Bone staples:  The bone staples are made from polyetheretherketone (PEEK), which is a 
common polymer used for bone anchors in orthopedic surgery. The bone staples are not 
bioabsorbable. 
The Rotation Medical Rotator Bioinductive Implant has been cleared by the U.S. Food and 
Drug Administration (FDA) [K140300; K122048; K131635; K131637].  The purpose of 
this post-market study is to collect and analyze outcomes data under a common protocol. 
 
 
Protocol Number: 3672-01 
Created: February 12, 2016

 
 
 
  
Figure 1: Rotation Medical Implantable System Components 
 
 
The tendon and bone staplers used to affix the bioinductive implant to tendon tissue and 
the calcaneus respectively are shown in Figure 2.  These are designed as single-use 
devices. 
Figure 2: Rotation Medical Single-Use Disposable Staplers 
 
 
Tendon stapler 
Bone stapler 
 
2.2 
PRINCIPLES OF OPERATION 
No investigational devices or procedures will be used in this post-market study and all 
devices will be used according to their indications for use.  Operation, indication, and 
instructions for use are described in the Instructions for Use (IFUs). 
 
 
Bioinductive 
implant 
Tendon 
staple 
Bone 
staple 
Protocol Number: 3672-01 
Created: February 12, 2016

 
 
 
  
3 
STUDY OBJECTIVE 
To evaluate bioinduction of new tissue and tendon healing after implantation of the 
Rotation Medical Bioinductive Implant used in the treatment of insertional Achilles 
tendonapathy. 
4 
STUDY DESIGN 
This is a prospective, non-randomized, single-arm study conducted under a common 
protocol designed to evaluate long-term outcomes following open treatment and 
implantation of the Rotation Medical Bioinductive Implant to treat insertional Achilles 
tendinopathy. 
4.1 
SAMPLE SIZE 
Up to 10 subjects will be enrolled and treated with the Rotation Medical Bioinductive 
Impant at Union Memorial hospital and the associated Surgery Center. 
4.2 
STUDY DURATION 
Enrollment is anticipated to take up to 12 months and all subjects will be followed for two 
years after surgery.  Therefore, the overall study duration is estimated to be 36 months. 
4.3 
PRIMARY OUTCOME MEASURES 
4.3.1 Increase in Tendon Thickness 
Achilles tendon thickness will be measured pre-operatively (baseline) and the total 
thickness of the tendon and any newly induced tissue at the implant site will be measured 
at each follow-up visit using magnetic resonance imaging (MRI).  The mean (± SD) change 
in post-operative Achilles tendon thickness will be calculated at each follow-up interval.  
4.3.2 Integration and Maturation of New Tissue 
Integration and maturation of the newly induced tissue will be assessed by MRI at each 
post-operative follow-up. This outcome will assess, at a minimum, the following 
characteristics of the newly induced tissue: (i) presence or absence of a clear boundary 
between the device and the underlying tendon; (ii) maturation of newly induced tissue to 
resemble characteristics of underlying tendon tissue (versus debris, artifact, or 
calcification). 
4.3.3 Tear Rate 
Tear rate following Achilles surgery will be assessed at each follow-up visit using MRI.  
4.4 
SECONDARY OUTCOME MEASURES 
4.4.1 Safety 
Safety will be evaluated by any of the following adverse events that occur over the duration 
of the study:  
1. Any death 
2. All serious adverse events (SAE) regardless of relation to the device or procedure 
3. Any non-serious adverse event (AE) that is classified as either device or procedure-
related  
4. Any unanticipated adverse device effect (UADE) 
Protocol Number: 3672-01 
Created: February 12, 2016

 
 
 
  
Adverse events will be summarized by relation to the study devices or study procedure.  
Overall occurrence rate by event type will also be calculated. 
4.4.2 Procedure Parameters 
The following procedural parameters will be recorded on all subjects: 
1. Device implant time: Mean (± SD) implant time defined as follows: 
Open procedure: Time from introduction of the bioinductive implant into the surgical 
field to completion of the last staple 
2. Procedure technical success: The proportion of subjects where the device was 
successfully delivered and affixed to target tendon location. 
3. Device implant position: An intra-operative photograph(s) or video recording 
showing the implant location of the device and all tendon and bone staples will be 
obtained. 
4.4.3 Recovery 
The following post-operative recovery parameters will be reported after discharge 
from the from study procedure: 
1. CAM boot time: cumulative number of days spent in a CAM boot 
2. Rehabilitation time: cumulative number of completed rehabilitation or physical 
therapy (PT) visits (mean ± SD) to treat index Achilles 
3. Return to work: cumulative number of days (mean ± SD) between discharge and 
return to work (employed subjects only) 
4. Return to normal daily activities (i.e. full, unrestricted activity): cumulative number 
of days (mean ± SD) between discharge and return to normal daily activity 
4.4.4 Subject Satisfaction 
Subject satisfaction is a self-reported measure of satisfaction with the outcome of the index 
surgery.  The level of satisfaction is assessed with a 5-point Likert scale.  Each subject will 
also be asked to indicate whether (s)he would recommend the study procedure to a friend 
(“yes/no”).  
5 
STATISTICAL ANALYSIS PLAN 
This is an initial feasibility study and not powered to address the hypotheses. Changes in 
tendon thickness over the time of the follow up visits will be assessed by a Repeated 
Measures ONEWAY ANOVA with a post hoc Scheffe.  Indices of new tissue integration 
and maturation at each follow up visit will be assessed by Chi Square analyses.   
 
6 
ELIGIBILITY CRITERIA 
Subjects who meet all inclusion criteria (Section 6.1) and none of the exclusion criteria 
(Section 6.2) will be eligible to participate in the study. 
Enrollment in the study occurs upon intra-operative confirmation that the subject meets all 
of the inclusion criteria and none of the exclusion criteria.  Subjects who meet eligibility 
criteria and are enrolled will be followed per protocol through the end of the study (i.e., 
intent-to-treat).  Subjects who do not meet the study eligibility criteria at the time of surgery 
will not be enrolled.  
Protocol Number: 3672-01 
Created: February 12, 2016

 
 
 
  
6.1 
INCLUSION CRITERIA 
Subjects enrolled in the study MUST meet all of the following criteria: 
1. At least 21 years of age 
2. Insertional Achilles tendinopathy  requiring surgery  
3. Chronic insertional Achilles tendinopathy lasting longer than 3 months unresponsive 
to conservative therapy including, but not limited to, pain medication, physical 
therapy and shoe modification 
4. MRI of the Achilles within 60 days prior to the study procedure 
5. Willing to comply with the prescribed post-operative rehabilitation program 
6. Willing to be available for each protocol-required follow-up examination 
7. Able to understand the informed consent process, including regulatory requirements 
such as HIPAA authorization, and document informed consent prior to completion of 
any study-related procedures 
8. Ability to read, understand, and complete subject-reported outcomes in English 
6.2 
EXCLUSION CRITERIA 
Subjects enrolled in the study MUST NOT meet any of the following criteria: 
1. Achilles tendon tear 
2. Previous Achilles tendon surgery on the index ankle 
3. Genetic collagen disease 
4. History of auto-immune or immunodeficiency disorders 
5. History of chronic inflammatory disorders 
6. Oral steroid use in last 2 months or injectable steroid use in last 4 weeks 
7. History of heavy smoking (> 1 pack per day) within last 6 months 
8. Hypersensitivity to bovine-derived materials 
9. Hypersensitivity to Polylactic Acid (PLA) and Polyetheretherketone (PEEK) materials 
10. Metal implants, fillings, shrapnel, and/or screws  
11. Females of child-bearing potential who are pregnant or plan to become pregnant during 
the course of the study 
12. Currently involved in any injury litigation or worker’s compensation claims relating to 
the index ankle 
13. Enrolled, or plans to enroll, in another clinical trial during this study that would affect 
the outcomes of this study 
14. History of non-compliance with medical treatment, physical therapy/rehabilitation, or 
clinical study participation 
15. History of cognitive or mental health status that interferes with study participation  
 
7 
STUDY ASSESSEMENTS 
The schedule of protocol-required study assessments is provided in Table 7.1.  Adverse 
event (AE) reporting as required and defined in Section 8 begins at the time of enrollment 
(i.e. intra-operative confirmation of eligibility) and concludes at the end of the study. 
 
 
 
Protocol Number: 3672-01 
Created: February 12, 2016

 
 
 
  
Table 7-1: Schedule of Study Assessments  
Study Evaluation 
Baseline 
Procedure 
3-Month 
1 Year 
2 Year 
Within 60 
Days of 
Surgery 
Within 60 
Days of 
Baseline 
± 15 days 
± 45 days 
± 90 days 
Informed Consent 
 
 
 
 
 
Medical History & Exam 
 
 
 
 
 
Eligibility Assessment 
 
1 
 
 
 
Enrollment (Date of Surgery) 
 
 
 
 
 
MRI 
2 
 
2 
2 
2 
Procedure Data 
 
 
 
 
 
Medications 
3 
3 
3 
3 
3 
Adverse Events 
 
4 
4 
4 
4 
Recovery/Satisfaction 
Questionnaire 
 
 
 
 
 
Revision/Additional Achilles 
Surgery 
 
 
5 
5 
5 
1Eligibilty confirmation will be performed at the time of the study surgery to ensure the patient meets 
eligibility criteria.  Patients who do not meet study eligibility criteria will not be enrolled in the study. 
2Each study MRI must be performed in accordance with the MRI study guideline. 
3Only prescription medications to treat the index Achilles will be recorded. 
4Non-serious AEs will only be recorded if they are classified as either possibly or definitely related to 
either the study device or the study procedure. 
5Any additional surgical intervention performed on the index Achilles will be reported. 
 
7.1 
ELIGIBILITY ASSESSMENT 
Subjects are considered eligible for this study if they meet all of the inclusion criteria and 
none of the exclusion criteria as defined in Section 6.1 and Section 6. 2.  The Investigator, 
co-Investigator, or sub-Investigator performing the study surgery will confirm eligibility.   
7.2 
ENROLLMENT 
Enrollment in the study occurs upon clinical confirmation that the subject meets all of the 
inclusion criteria and none of the exclusion criteria.  Patients who do not meet study 
eligibility criteria at the time of the study procedure will undergo tendon repair at 
the discretion of the surgeon (without use of the Rotation Medical Bioinductive 
Implant) and will not be enrolled in the study.  The date of the study surgery is defined 
as the enrollment date and all subjects who are enrolled in the study will be followed per 
protocol unless voluntary consent is withdrawn.  All subjects enrolled into the study will 
be identified through a unique identifier.   
7.3 
BASELINE ASSESSMENT 
During the baseline assessment, the following activities must be conducted within 60 
calendar days prior to enrollment: 
1. Obtain written informed consent 
Protocol Number: 3672-01 
Created: February 12, 2016

 
 
 
  
2. Obtain medical history 
3. Perform an MRI per the Sponsor imaging guidelines 
 Provide the Sponsor with a de-identified digital copy, or access to the MRI 
4. Assess subject eligibility based on inclusion/exclusion criteria defined in Section 6.1 
and 6.2. 
5. Record prescription medications 
 Record any prescription medications the subject is taking at the time of the 
baseline visit to treat his/her index Achilles 
6. Administer VISA-A (Victorian Institute of Sports Assessment-Achilles 
questionnaire) form to assess Achilles tendon pain. 
7.4 
PROCEDURE ASSESSMENT 
During the study procedure, use of any biological agents or implants aimed at augmenting 
tendon-to-bone healing, excluding the Rotation Medical Bioinductive Implant, are strictly 
prohibited.  Intra-operative data along with the following study-specific procedure 
information will be documented on the Procedure CRF: 
1. Device implant time 
2. Procedure technical success 
3. Device implant position 
 After implantation of the device, an intra-operative photograph(s) or video 
recording showing the implant location of the device and all tendon and bone 
staples will be obtained. 
4. Intra-operative complication (if applicable; per Section 8) 
7.5 
PROCEDURE RULES 
Subjects should be scheduled to undergo the study procedure within 60 days of 
baseline assessment.  Device implantation will be performed in accordance with the 
Rotation Medical Bioinductive Implant System device and instrument Instructions for Use 
(IFUs) and may be performed as an open procedure. 
All subjects will be place in a supine position with a small bump under the contralateral 
hip. A tourniquet will be placed on the operative leg. A standard incision will be placed 
just medial to the Achilles tendon. The Achilles will be detached from the calcaneus, 
undergo debridement and assessed for integrity.  The posterior aspect of the calcaneus will 
undergo exostectomy. At the surgeon’s discretion the flexor hallucis longus tendon will be 
harvested. The Achilles tendon will be re-attached to the posterior aspect of the calcaneus 
using suture anchors. If the FHL is harvested a supplemental oblique tunnel will be created 
using a small burr. The FHL will be passed through the tunnel, woven through and attached 
to the remaining debrided Achilles tendon. Following the bioinductive implant will be 
attached to the Achilles tendon. 
7.6 
POST-OPERATIVE CARE 
Post-operative care, including discharge instructions, pain management, and 
frequency/duration of physical therapy/rehabilitation regimen are at the discretion of the 
surgeon.  To minimize the likelihood that the integrity or position of the device is 
compromised after implant, recommended rehabilitation guidelines are provided in Table 
7.2.  
Protocol Number: 3672-01 
Created: February 12, 2016

 
 
 
  
 
Table 7-2: Post-operative Rehabilitation Guidelines  
Study Procedure 
Rehabilitation Guidelines 
Device implant  
 Remain in post mold splint until follow up 
 Remain nonweight bearing on operative leg with crutches or walker 
 Follow up in one week for evaluation and placement into CAM boot 
with heel lift 
 Follow up at 2 weeks for suture removal 
 Follow up at 4 weeks for partial heel lift removal and progression to 
neutral foot 
 Follow up at 4 weeks for start of physical therapy 
 Fill out VISA-A (Victorian Institute of Sports Assessment-Achilles 
questionnaire) at 6 and 12 months 
7.7 
FOLLOW-UP ASSESSMENTS 
All subjects will undergo post-operative study assessments at 3 months, 1 year, and 2 years 
after discharge from the study procedure as described below and summarized in Table 7.1. 
7.7.1 3-Month (± 15 Days) Follow-Up 
1. Perform an MRI per the Sponsor Imaging guidelines. 
 Provide the Sponsor with a de-identified digital copy of, or access to,  the MRI 
2. Clinical Assessment 
3. Record prescription medications 
 Record any prescription medications the subject is taking at the time of the 
follow-up visit to treat his/her index Achilles. 
4. Record any new adverse events and update the status of any ongoing, previously-
reported adverse events. 
5. Report any new revision/additional Achilles surgeries performed on the index 
Achilles 
7.7.2 1-Year (± 45 Days) Follow-Up 
1. Perform an MRI per the Sponsor imaging guidelines. 
 Provide the Sponsor with a de-identified digital copy of, or access to, the MRI. 
2. Clinical assessment 
3. Administer the recovery/satisfaction questionnaire (VISA-A) 
4. Record prescription medications. 
 Record any prescription medications the subject is taking at the time of the 
follow-up visit to treat his/her index Achilles. 
5. Record any new adverse events and update the status of any ongoing, previously-
reported adverse events. 
6. Report any new revision/additional Achilles surgeries performed on the index 
Achilles. 
7.7.3 2-Year (± 90 Days) Follow-Up 
1. Perform an MRI per the Sponsor imaging guidelines. 
Protocol Number: 3672-01 
Created: February 12, 2016

 
 
 
  
 Provide the Sponsor with a de-identified digital copy of, or access to, the MRI. 
2. Clinical assessment 
3. Administer the recovery/satisfaction questionnaire. 
4. Record prescription medications. 
 Record any prescription medications the subject is taking at the time of the 
follow-up visit to treat his/her index Achilles. 
5. Record any new adverse events and update the status of any ongoing, previously-
reported adverse events. 
6. Report any new revision/additional Achilles surgeries performed on the index 
Achilles. 
 
The results of all follow-up assessments will be documented on their respective CRFs.  
Each reportable adverse event (Section 4.1.1) will be documented on an Adverse Event 
CRF. 
7.8 
UNSCHEDULED FOLLOW-UP 
Any unscheduled return visits to the study center/Principal Investigator for non-standard 
of care evaluation for ongoing Achilles-related issues will be documented. Visits required 
by the protocol or visits for routine post-operative follow-up are not considered 
unscheduled and do not need to be reported as an unscheduled visit.  
7.9 
REVISION/ADDITIONAL ACHILLES SURGERY 
If the subject has additional or revision Achilles surgery on the index Achilles at any time 
during the follow-up period, the clinical site should make every effort to collect the 
procedure/operative notes for the procedure and complete the Revision/Additional Achilles 
Surgery.   
7.10 EARLY WITHDRAWAL OR LOST TO FOLLOW-UP 
If a subject wishes to withdraw from the study at any time, (s)he is able to do so 
voluntarily without having to justify it and without affecting her/his relationship with the 
Investigator.  
Also, an Investigator may withdraw a subject from the study at any time if (s)he thinks it is 
in the subject’s best interest.  
The subject’s future management will not be changed by a decision, voluntary or 
otherwise, to withdraw from the study. 
All reasonable efforts should be made to retain the subject in this clinical study until 
completion of the clinical assessments at each follow-up visit.  A subject will be 
considered “lost to follow-up” after a minimum of 2 documented phone calls to the subject 
were completed by a member of the study staff and a certified letter was sent to the last 
known address by a traceable method (e.g., certified mail; courier; commercial 
shipping/transport company). 
Protocol Number: 3672-01 
Created: February 12, 2016

 
 
 
  
7.11 END OF STUDY  
Subjects will be exited upon successful completion of follow-up assessments or at the time 
of withdrawal or lost-to-follow-up.  
 
8 
ADVERSE EVENT DEFINITIONS AND REPORTING 
Adverse events are to be reported from the time of enrollment through the last study 
follow-up visit. 
8.1 
DEFINITION OF ADVERSE EVENT (AE) 
An Adverse Event (AE) is any undesirable clinical occurrence experienced by the subject.  
Any underlying disease that was present at the time of enrollment and prior to surgery that 
persists after surgery is not considered an AE. 
8.2 
SERIOUS ADVERSE EVENT (SAE) 
A Serious Adverse Event (SAE) includes any of the following events: 
 Results in death 
 Is life threatening 
 Requires subject hospitalization or prolongation of existing hospitalization 
 Requires invasive surgical intervention to fix the problem 
 Results in persistent or significant disability/incapacity 
 Is considered an important medical event 
An important medical event that may not meet one of the above definitions might be 
considered as an SAE if it jeopardizes the health of the subject or requires surgical 
intervention to prevent one of the outcomes listed in the above definition.  Elective 
hospitalization after the procedure that was planned prior to subject enrollment is not to be 
considered as an SAE.   
8.3 
UNANTICIPATED ADVERSE DEVICE EFFECT (UADE) 
An Unanticipated Adverse Device Effects (UADE) is any serious adverse effect on health 
or safety, or any life-threatening problem or death caused by, or associated with, a device, 
if that effect was not previously identified in nature, severity, or degree of incidence in 
protocol, subject informed consent form, or application, or any other unanticipated serious 
problem associated with a device that relates to the rights, safety, or welfare of subjects.  
Anticipated adverse events are listed as known risks in Section 12.1. 
8.4 
ASSESSING, RECORDING AND REPORTING AES, SAES, AND UADES 
Only non-serious AEs that are classified by the Investigator as either device-related or 
procedure-related will be reported.  All SAEs, regardless of relationship to the Rotation 
Medical Bioinductive Implant, and all UADEs will be reported. 
An AE may be volunteered spontaneously by the subject or discovered as a result of 
questioning or physical examination by the Investigator or study staff.  The following 
information should be reported on the Adverse Event CRF as soon as the Investigator 
becomes aware of the event and updated as needed until event resolves: 
Protocol Number: 3672-01 
Created: February 12, 2016

 
 
 
  
 Date of AE onset 
 Date the Investigator became aware of the AE 
 Main complaints/symptoms of the AE 
 Relationship to the study device 
 Relationship to the study procedure 
 Status of the adverse event 
Source documents (e.g., procedural notes, treatment notes, or a signed clinical summary) 
may be required as supporting documentation for the reported AE. 
9 
MALFUNCTIONS 
Failure of the Rotation Medical Bioinductive Implant to meet its performance 
specifications or to perform as intended will be documented on the Malfunction CRF.  In 
the event of a malfunction, every effort must be made to return the suspected Rotation 
Medical device or instrument to the Sponsor for analysis.  Malfunctions will be evaluated 
for reportable requirements through the FDA medical device reporting (MDR) system. 
 
10 PROTOCOL DEVIATIONS 
Investigators are required to adhere to the study protocol, signed Clinical Trial Agreement 
(CTA), applicable national or local laws and regulations, and any conditions required by 
the appropriate IRB/EC or applicable regulatory authorities. 
 
A protocol deviation is used to describe situations in which the protocol was not followed 
(this includes all activities at each scheduled visit or activities occurring outside of the 
study windows).  All attempts should be made to obtain Sponsor approval of the deviation 
prior to their occurrence. 
 
An Investigator must notify the Sponsor and the reviewing IRB/EC of any deviation from 
the Study Protocol that was done to protect the life or physical well-being of a subject 
(medical emergencies).  Such notice should be given within 5 days of the occurrence.  The 
Sponsor will determine if the subject affected is to continue in the study. 
 
Documentation of deviations identified by the investigational center, the monitor, or other 
Sponsor representative(s) will be entered into the Protocol Deviation CRF for the purpose 
of tracking Investigator compliance with the protocol.  The investigational center will be 
required to document actions taken to prevent recurrence of deviations.  The Sponsor 
representative will initiate corrective actions based on individual deviations or trending 
reports as appropriate. 
 
 
 
 
 
Protocol Number: 3672-01 
Created: February 12, 2016

 
 
 
  
11 REPORTING REQUIREMENTS 
Table 11-1 shows a summary of all reporting requirements.  In addition to this list, 
individual IRBs may add additional reporting requirements and/or require a different 
notification time frame. 
Table 11-1: Summary of Reporting Requirements  
Type of Report 
Prepared by 
Investigator FOR 
Notification Time Frame 
Death1 
Sponsor & IRB 
Within 24 hours of knowledge 
Withdrawal of IRB approval 
Sponsor 
Within 5 working days of knowledge 
Protocol Deviation to Protect 
Subject Life or Physical 
Well-Being 
Sponsor & IRB 
Within 5 working days of knowledge 
Unanticipated Adverse 
Device Effect (UADE) 
Sponsor & IRB 
Within 10 working days of knowledge 
1Copies of death records, medical records for the events that led to the subject’s death, a death 
certificate (if available), and an autopsy report (if performed) should be requested. 
 
12 RISKS AND BENEFITS 
12.1 RISKS AND RISK MITIGATION 
Study patients will be informed of all known potential side effects and complications 
associated with the study assessments and study procedure prior to enrollment in the study. 
There are no known incremental risks to the subject for participating in the study.  The 
risks associated with participating in this study are the same as if the patient is treated 
outside of the study using the same commercially-available device and include the 
following potential risks of Achilles Tendinopathy surgery performed under general or 
regional anesthesia: 
 Tissue inflammation 
 The need for repeated surgery because tendons do not heal properly or tears 
 Pain or stiffness that won't go away 
 Fever and/or infection 
 Complication from anesthesia 
 Nerve or blood vessel damage  
 Adverse reaction to device 
In addition, subjects will be required to undergo MR imaging.  MRI is generally a well-
tolerated procedure and there is no ionizing radiation involved with MR imaging   The 
potential risks are minimal and include claustrophobia, coil element heating and peripheral 
nerve stimulation, although the latter two are considered highly unlikely, given that the 
subjects will be imaged within preset safety guidelines to eliminate peripheral nerve 
stimulation. Coil element heating ranges from a mild sensation of heat to a potential burn.  
This is considered highly unlikely, as the coils have all undergone extensive testing and 
clinical use, and special pads are placed surrounding all contact points. 
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All Investigators will undergo training and subjects will be screened and evaluated for 
medical histories/conditions that may compromise safe, successful completion of any of 
the study assessments or performance of the device.  Subjects with a known 
hypersensitivity to bovine-derived materials will not be enrolled in the study. 
12.2 BENEFITS 
Participation in this study is voluntary.  Subjects can obtain the same treatment without 
participating in this study.  However, information gathered from this study will help the 
Sponsor to continue to evaluate long-term performance of the device. 
 
13 DATA MANAGEMENT 
13.1 DATA COLLECTION 
Report forms will be completed by the Investigator (or authorized study personnel) for 
each subject enrolled in the study.  Data queries and edit checks will be used to reconcile 
discrepancies between data on the source documents and data entered on the CRFs.  The 
Investigator must assure the accuracy and completeness of the recorded data.  For the 
purpose of this study, the ASES and Constant shoulder surveys, as well as the 
Recovery/Satisfaction form, may act as their own source data. 
13.2 DATA PROCESSING 
All study documentation will be entered and maintained in a central database by the 
Sponsor or Sponsor-authorized representatives.  Automatic and/or manual edit checks will 
be issued as necessary to correct discrepant data.  Appropriate quality control measures 
will be established to ensure accurate and complete transfer of information from the study 
documentation to the central database.  Data files will be exported from the central database 
for statistical analyses. 
14  ADMINISTRATIVE RESPONSIBILITIES 
14.1 SITE AND INVESTIGATOR SELECTION 
Each site and Investigator selected to participate will be evaluated to ensure each has the 
capacity, volume of surgical candidates, and capability to comply with all informed 
consent and protocol requirements. Each study site and Investigator are required to 
comply with applicable local legal and regulatory requirements and applicable U.S. 
federal regulations. 
14.2 TRAINING 
The principal investigators must be Board Certified orthopaedic surgeons with experience 
performing surgery for insertional Achilles tendinopathy.  Prior to first enrollment, each 
participating surgeon will complete Sponsor-provided training on the Rotation Medical 
Bioinductive implant System.   
The Sponsor will also be responsible for ensuring each site and Investigator are properly 
trained on the study protocol and applicable regulatory requirements. 
To insure uniform data collection and protocol compliance, the Sponsor or Sponsor-
authorized representatives will train the Study Coordinator(s) and study staff on all 
Protocol Number: 3672-01 
Created: February 12, 2016

 
 
 
  
components of the study including the study protocol, techniques for the identification of 
eligible subjects, instructions for data collection during the procedure, and schedules for 
follow-up. 
14.3 INSTITUTIONAL REVIEW BOARD (IRB) / ETHICS COMMITTEE (EC) 
It is the Investigator’s responsibility to obtain and maintain written approval of the final 
study protocol and Informed Consent from the appropriate IRB or Ethics Committee.  
Investigators are responsible for submitting and obtaining initial and continuing review of 
the trial by their IRB/EC.  It is also the Investigator’s responsibility to notify the IRB/EC 
of any amendments to these documents.  A copy of the written approval must be forwarded 
to the Sponsor prior to first device shipment.  The written approval must identify the study 
and document the date of review. 
The Investigators must keep on file all study-related correspondence with the IRB/EC and 
forward copies of such correspondence to the Sponsor. 
14.4 INFORMED CONSENT FORM (ICF) 
Informed consent must be obtained in accordance with the applicable guidelines or local 
regulations and laws, whichever represents the greater protection of the individual.  The 
subjects must be informed about their right to withdraw from the study at any time and for 
any reason without sanction, penalty, or loss of benefits to which the subject is otherwise 
entitled and also informed that withdrawal from the study will not jeopardize their future 
medical care.  The institutional standard subject consent form does not replace the study 
informed consent form (ICF). 
The Sponsor will provide a study-specific template ICF to each site for IRB/EC 
submission.  This template may be modified to suit the requirements of the individual study 
site.  The Sponsor must pre-approve all changes to the ICF prior to initial submission to 
the IRB/EC.  The Informed Consent Form must be approved by the IRB/EC prior to device 
shipment and a copy must be retained at the investigational site along with the other 
investigational forms.  A signed copy of the consent form must be given to each subject 
enrolled in the study and a signed copy of the consent form must be retained for each 
subject at the investigational site. 
Modifications to the study-specific Informed Consent Form and/or any written information 
distributed to subjects must be approved by the Sponsor, and the IRB/EC as necessary. 
14.5 CONFIDENTIALITY 
All information and data sent to the Sponsor concerning subjects or their participation in 
this study will be considered confidential.  All data used in the analysis and reporting of 
this evaluation will be used in a manner without identifiable reference to the subject.  The 
Investigator consents to visits by the staff of the Sponsor and its authorized representatives 
and the U.S. FDA or any other local governmental body to review the study subjects’ 
medical records, including any test or laboratory data that might have been recorded on 
diagnostic test media (e.g., MRI scan). 
14.6 AMENDING THE PROTOCOL 
The Sponsor must write amendments in order to alter the protocol.  Administrative changes 
that do not affect the subject benefit/risk ratio (e.g., editorial changes for clarity) may be 
Protocol Number: 3672-01 
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implemented without any further approvals.  Any change that would require alteration of 
the Informed Consent form must receive approval from all persons who approved the 
original protocol and from the IRB/EC prior to implementation.  Following approval, the 
protocol amendment(s) will be distributed to all protocol recipients with instructions to 
append them to the protocol. 
14.7 CRITERIA FOR TERMINATING STUDY 
The Sponsor reserves the right to terminate the study early but intends only to exercise this 
right for valid scientific or administrative reasons or reasons related to the protection of 
study subjects.  Investigators and associated IRB/EC will be notified in writing in the event 
of termination.  Reasons for study termination include but are not limited to: 
 The discovery of an unexpected, significant, or unacceptable risk to the study subjects. 
 A decision on the part of the Sponsor to suspend or discontinue commercial 
distribution of the Rotation Medical Bioinductive Implant.  
14.8 CRITERIA FOR TERMINATING AN INVESTIGATIONAL CENTER 
The Sponsor reserves the right to stop enrollment of subjects at an investigational center at 
any time for any of the following reasons including but not limited to: 
 Repeated failure to complete case report forms (CRFs) 
 Failure to obtain Informed Consent 
 Failure to report any study subject deaths, SAEs, or UADEs within the timeframes 
specified in Table 11-1 
 Repeated protocol deviations 
 Lack of study enrollment or study activity 
14.9 SPONSOR RESPONSIBILITIES 
The Sponsor’s responsibilities for this study are to: 
 Provide sufficient training to support study activities per agreements executed with the 
study sites 
 Select all clinical Investigators, study sites, and consultants (e.g., the study monitors) 
who participate in the study 
 Provide financial support to each study site per agreements executed with the study 
sites 
 Follow all regulatory standards per federal regulations for clinical study sites, core 
laboratories, and other participants, and ensure regular site monitoring to assure 
compliance with them 
 Retain ownership of all clinical data generated in this study 
 Work collaboratively with Investigators to present and publish study results 
14.10 INVESTIGATOR RESPONSIBILITIES 
The Investigator for each site is responsible for ensuring the study is conducted according 
to: 
 All signed agreements 
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 The study protocol 
 IRB/EC guidelines 
 Applicable FDA regulations 
The Investigator for each site may not begin enrollment until the Sponsor receives and 
approves (when necessary) required documents, including the complete signed 
Investigator Agreement, Protocol Signature Page, IRB/EC and ICF approvals.  
It is acceptable for the Investigator to delegate one or more of the above functions to an 
associate or Co-Investigator or trained Study Coordinator; however, the Investigator 
remains responsible for the proper conduct of the clinical investigation, including 
obtaining the ICF, collecting all required data, submitting accurate and complete CRFs, 
etc. 
At each site, appropriate procedures must be followed to maintain subject confidentiality 
according to HIPAA (Health Insurance Portability Accountability Assurance) regulations.  
Each site may have its own internal procedures or requirements for use and release of 
subject medical information in research studies.  Each Investigator is responsible for 
obtaining appropriate approvals, consents or releases of medical information as dictated 
by their relevant subject privacy regulations. 
The study is not transferable to other sites attended by the Investigator unless prior 
approval is obtained from the appropriate IRB and the Sponsor.   
15 MONITORING AND AUDITING 
Monitoring visits to the investigational centers will be made frequently during the study to 
ensure that all aspects of the current approved protocol/amendment(s) are followed.  Source 
documents will be reviewed for verification of agreement with data entered on the CRFs 
and all regulatory documents will be checked for accuracy including but not limited to 
IRB/EC approvals, study-related correspondence, and subject informed consent.  The 
Investigator/institution guarantees direct access to source documents by designated 
Sponsor personnel and appropriate regulatory authorities.  The site staff must agree to be 
available to meet with the Sponsor during each visit. 
The study may also be subject to a quality assurance audit by the Sponsor or its designees 
as well as inspection by appropriate regulatory authorities. 
 
16 REPORTS AND RECORDS 
16.1 REPORTS 
Adverse events and Rotation Medical Bioinductive Implant malfunctions will be 
evaluated for reportable requirements through the FDA medical device reporting (MDR) 
system. 
16.2 RECORDS 
All records pertaining to the clinical study will be kept for a minimum of 3 years following 
the date on which the study is terminated or completed. 
 
Protocol Number: 3672-01 
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17 USE OF INFORMATION AND PUBLICATION  
Any previously unpublished information provided to the Investigators by the Sponsor, such 
as patent applications, manufacturing processes and basic scientific data, is considered 
confidential and will remain the sole property of the Sponsor.  The Investigator agrees to 
use this information only in accomplishing this study and will not use it for other purposes 
without the Sponsor’s written consent. 
An Investigator may publish the study experience from his/her site subject to approval by 
the Sponsor.  The Sponsor will work collaboratively with Investigators to support data 
analyses for publication of study results.  The Sponsor reserves the right to review all 
publications in order to verify accuracy of the data.  The Investigator may proceed with the 
publication when notified by the Sponsor. 
For any multi-center publications (if applicable), the number, names, and order of the 
authors will be determined by the Sponsor with input from the Investigators. 
 
Protocol Number: 3672-01 
Created: February 12, 2016