PMCF Study on PEEK Suture Anchors for Hip Indications
Conditions: Soft Tissue to Bone Fixation
Sponsor: Smith & Nephew, Inc.

 
Study Protocol
Device 
PMCF Study on PEEK Suture Anchors for Hip 
Indications 
Number: 2018.14.SMD.PEEK.RET.HIP
Version: 2.0, 03 April 2019
Page:  1 of 63 
 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
SOP-059 Clinical Protocols 
 
 
PMCF Study on PEEK Suture Anchors for Hip Indications 
 
 
Protocol Number: 
2018.14.SMD.PEEK.RET.HIP 
Protocol Version:  
Version 2.0 
Date: 
03 April 19 
Study Product Names: 
PEEK Hip Suture Anchors 
Bioraptor Knotless Suture Anchor 
SpeedLock Hip Suture Anchor 
 
Sponsor: 
Smith & Nephew Orthopaedics 
7135 Goodlett Farms Parkway  
Cordova, TN 38016 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
Study Protocol
Device 
PMCF Study on PEEK Suture Anchors for Hip 
Indications 
Number: 2018.14.SMD.PEEK.RET.HIP
Version: 2.0, 03 April 2019
Page:  2 of 63 
 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
SOP-059 Clinical Protocols 
 
 
 
 SIGNATURES 
1.1 PROTOCOL SIGNATURE PAGE 
This page will be returned to Smith & Nephew Inc. and a copy retained at the investigational site. 
 
I have read th
PMCF Study on PEEK Suture Anchors for Hip Indications
version 2.0, dated 03April2019, and agree to abide by all provisions set forth herein. 
I agree to comply with the Investigator  Obligations stipulated in Section 26.1 of the protocol,  
I agree to ensure that the confidential information contained in this document will not be used for 
any purpose other than the conduct of the described clinical investigation without the prior written 
consent of Smith & Nephew, Inc.  
Role 
Name 
Signature* 
Date Signed* 
(DD-MMM-YYYY) 
Principal Investigator  
 
 
 
 

 
Study Protocol
Device 
PMCF Study on PEEK Suture Anchors for Hip 
Indications 
Number: 2018.14.SMD.PEEK.RET.HIP
Version: 2.0, 03 April 2019
Page:  3 of 63 
 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
SOP-059 Clinical Protocols 
 
 REVISION HISTORY, OWNERSHIP, AND APPROVALS: 
2.1 REVISION HISTORY 
 
 
 
 
 
 
 
 
 
 
 
[Intentionally left blank]

Study Protocol
Device
 
PMCF Study on PEEK Suture Anchors for Hip 
Indications 
Number: 2018.14.SMD.PEEK.RET.HIP 
Version: 2.0, 03 April 2019 
Page:  4 of 63 
 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is intended for use only by Smith & Nephew and its 
manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
SOP-059 Clinical Protocols 
 
Version  
 
Page 
Item 
Original 
New 
Reason 
1.0 
N/A 
N/A 
Initial Protocol 
Revision 2.0 
 
N/A 
2.0 
2 
Protocol 
Signature Page 
1.0 
12Sep18 
2.0 
03April19 
Administrative 
2.0 
3 
Revision 
History 
Initial  
Protocol Amendment 2 
Administrative 
2.0 
19 
Signatures 
Sponsor Signatures 
Removed duplicate sponsor signature lines 
Administrative 
2.0 
20, 32 
Part Numbers 
N/A 
Added: Part numbers as of September 2018 
Administrative 
2.0 
20 
Min/Max 
Minimum, n=40 
Maximum, n=80 
 
Minimum number of subjects, n=40 
Maximum number of subjects, n=240 
 
Administrative/Clarification 
2.0 
20 
Enrollment 
Distribution 
N/A 
Enrollment distribution: 
Up to three sites will enroll a maximum of 40 subjects per 
anchor configuration; therefore, no more than 120 subjects 
will be enrolled for any anchor type.   
 
Rationale for enrollment 
distribution among sites 
and between anchors. 
2.0 
21 
Sample Size 
PEEK 
Anchor 
Minimum  Maximum  
Bioraptor 
Knotless 
Suture 
Anchor 
20  
40  
PEEK 
Anchor 
Minimum 
Number of 
Subjects/Site 
Maximum 
Number of 
Subjects/Site 
Maximum 
Number 
of 
Subjects 
Administrative/Clarification 

Study Protocol
Device
 
PMCF Study on PEEK Suture Anchors for Hip 
Indications 
Number: 2018.14.SMD.PEEK.RET.HIP 
Version: 2.0, 03 April 2019 
Page:  5 of 63 
 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is intended for use only by Smith & Nephew and its 
manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
SOP-059 Clinical Protocols 
 
Version  
 
Page 
Item 
Original 
New 
Reason 
SpeedLock 
Hip 
 
20  
40  
 
for the 
Study 
Bioraptor 
Knotless 
Suture 
Anchor 
20 subjects 
per site 
40 subjects 
per site 
120 
subjects 
SpeedLock 
Hip 
 
20 subjects 
per site 
40 subjects 
per site 
120 
subjects 
Total 
40 subjects 
80 subjects 
240 
subjects 
 
2.0 
21 
Inclusion 
Criteria 
1. 
Subjects who have undergone 
shoulder joint repair using the 
study devices.  
2. Subjects aged 18 years and 
older at the time of surgery. 
 
1. 
Subjects who have undergone shoulder joint repair 
using the study devices.  
2. Subjects aged 18 years and older at the time of 
surgery. 
3.  Subjects must have had a visit to their provider 
between 3 and 15 months post-operative. 
Clarification 
2.0 
21 
Exclusion 
Criteria 
1. 
Subjects who are < 12 months 
post-operative. 
2. Subject is entered in another 
investigational drug, biologic, 
or device study or has been 
treated with an investigational 
1. 
Subjects who are < 12 months post-operative. 
2. Subject is entered in another investigational drug, 
biologic, or device study or has been treated with 
an investigational product within 30 days prior to 
surgery. 
Clarification 

Study Protocol
Device
 
PMCF Study on PEEK Suture Anchors for Hip 
Indications 
Number: 2018.14.SMD.PEEK.RET.HIP 
Version: 2.0, 03 April 2019 
Page:  6 of 63 
 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is intended for use only by Smith & Nephew and its 
manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
SOP-059 Clinical Protocols 
 
Version  
 
Page 
Item 
Original 
New 
Reason 
product within 30 days prior 
to surgery. 
 
3. Subject had off-label use of the PEEK suture anchor 
during surgery. 
2.0 
21, 37 
Primary 
Endpoint 
Clinical success rate (%) at 6 months 
post-operative. 
Clinical success rate (%) at 6 months post-operative based 
on standard of care. 
Clarification 
2.0 
21, 37 
Secondary 
Endpoint 
Clinical success rate (%) at 12 months 
post-operative. 
Clinical success rate (%) at 12 months post-operative based 
on standard of care. 
Clarification 
2.0 
23 
SOE/ICF 
NA if waiver of consent approved by 
IRB 
NA if waiver of consent granted by IRB 
Clarification 
2.0 
23 
SOE/Footnote 
NA 
2  End of Study CRF can be completed at 6 months if the 
subject did not have a 12-month visit. 
 
Clarification 
2.0 
27 
List of 
Abbreviations 
BMI 
PHI 
PROs 
Removed.  Not applicable. 
Administrative 
2.0 
Throughout 
Minor 
formatting 
corrections 
__ 
___ 
Administrative 
2.0 
30 
IFUs 
PEEK Suture 
Anchor 
IFU 
PEEK Suture Anchor 
IFU 
Administrative 

Study Protocol
Device
 
PMCF Study on PEEK Suture Anchors for Hip 
Indications 
Number: 2018.14.SMD.PEEK.RET.HIP 
Version: 2.0, 03 April 2019 
Page:  7 of 63 
 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is intended for use only by Smith & Nephew and its 
manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
SOP-059 Clinical Protocols 
 
Version  
 
Page 
Item 
Original 
New 
Reason 
Bioraptor 
Knotless Suture 
Anchor 
10600479 2/17, 
Rev E 
SpeedLock 
P/N 62513 
March 2017, Rev 
B 
 
Bioraptor Knotless Suture 
Anchor 
10600479 2/17, Rev E 
SpeedLock Hip Suture 
Anchor 
P/N 62513 March 2017, 
Rev B 
 
2.0 
30 
IFU 
N/A 
Instructions for Use document numbers have been provided 
as a reference but may not have been the version used at 
the time of surgery. 
 
Clarification 
2.0 
33 
Subject 
Population 
Enrollment will be in sequential order 
based on the date of their surgical 
procedure with the investigational 
device, i.e. earliest to latest. 
Enrollment will be in sequential order based on the date of 
their surgical procedure with the investigational device, i.e. 
time of surgery to present day. 
Clarification 
2.0 
33 
Inclusion 
Criteria 
1. 
Subjects who have undergone 
shoulder joint repair using the 
study devices.  
2. Subjects aged 18 years and 
older at the time of surgery. 
 
1. 
Subjects who have undergone shoulder joint repair 
using the study devices.  
2. Subjects aged 18 years and older at the time of 
surgery. 
3.  Subjects must have had a visit to their provider 
between 3 and 15 months post-operative. 
Clarification 
2.0 
34 
Exclusion 
Criteria 
1. 
Subjects who are < 12 months 
post-operative. 
2. Subject is entered in another 
investigational drug, biologic, 
1. 
Subjects who are < 12 months post-operative. 
2. Subject is entered in another investigational drug, 
biologic, or device study or has been treated with 
Clarification 

Study Protocol
Device
 
PMCF Study on PEEK Suture Anchors for Hip 
Indications 
Number: 2018.14.SMD.PEEK.RET.HIP 
Version: 2.0, 03 April 2019 
Page:  8 of 63 
 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is intended for use only by Smith & Nephew and its 
manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
SOP-059 Clinical Protocols 
 
Version  
 
Page 
Item 
Original 
New 
Reason 
or device study or has been 
treated with an investigational 
product within 30 days prior 
to surgery. 
 
an investigational product within 30 days prior to 
surgery. 
3.  Subject had off-label use of the PEEK suture anchor 
during surgery. 
2.0 
35 
LTFU 
A subject will be considered lost to 
follow-up if he/she did not return for 
follow-
standard of care. 
N/A 
Removed, as it is not 
applicable to this study. 
2.0 
36 
Study Design 
This is a retrospective, open-label, 
multicenter study to collect clinical data 
that will evaluate post-market safety 
and performance of the PEEK suture 
anchors in the hip. A minimum of 40 
subjects and maximum of 80 subjects 
in the United States who underwent 
surgery in the hip using the Smith & 
Nephew PEEK anchor sutures are 
planned to be enrolled into the study 
This is a retrospective, open-label, multicenter study to 
collect clinical data that will evaluate post-market safety and 
performance of the PEEK suture anchors in the hip.  A 
minimum of 40 subjects and a maximum of 240 subjects in 
the United States who underwent surgery in the hip using 
the Smith & Nephew PEEK suture anchors are planned to be 
enrolled into the study after the fulfilment of all inclusion and 
exclusion criteria.  Up to three sites will enroll a minimum of 
20 subjects and a maximum of 40 subjects per anchor 
Clarification 

Study Protocol
Device
 
PMCF Study on PEEK Suture Anchors for Hip 
Indications 
Number: 2018.14.SMD.PEEK.RET.HIP 
Version: 2.0, 03 April 2019 
Page:  9 of 63 
 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is intended for use only by Smith & Nephew and its 
manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
SOP-059 Clinical Protocols 
 
Version  
 
Page 
Item 
Original 
New 
Reason 
after the fulfillment of all inclusion and 
exclusion criteria. It is also planned that 
each investigational site would enroll a 
minimum of 6 subjects. 
 
 
configuration; therefore, not more than 120 subjects will be 
enrolled for any anchor type.  
 
 
2.0 
37 
Secondary 
Endpoint 
The secondary endpoint will be clinical 
success rate (%) at 12 months post-
operative based on standard of care.  
Clinical success has previously been 
defined.   
The secondary endpoint will be clinical success rate (%) at 12 
months post-operative based on standard of care.  Clinical 
success has previously been defined.  It is expected that per 
p
-month clinical data may not 
be available for all subjects.  
 
Clarification 
2.0 
39 
Concomitant 
Medications 
and Therapies 
Any concomitant medications 
associated with an AE, SAE or SADE 
will be recorded.   
 
Any concomitant medications associated with an AE, SAE or 
SADE will be recorded.  Concomitant medications will be 
recorded from the time of surgery through 12 months.  If the 
medications will be collect through 6 months. 
 
Clarification 

Study Protocol
Device
 
PMCF Study on PEEK Suture Anchors for Hip 
Indications 
Number: 2018.14.SMD.PEEK.RET.HIP 
Version: 2.0, 03 April 2019 
Page:  10 of 63 
 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is intended for use only by Smith & Nephew and its 
manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
SOP-059 Clinical Protocols 
 
Version  
 
Page 
Item 
Original 
New 
Reason 
2.0 
39 
General 
Smith 
group will conduct the statistical 
analysis for this study. Unless 
otherwise stated, all significance tests 
will be two-sided, performed at the 5% 
significance level. 
designee will 
conduct the statistical analysis for this study. Unless 
otherwise stated, all significance tests will be two-sided, 
performed at the 5% significance level. 
Clarification 
2.0 
39 
General 
Resulting p-values will be quoted and 
95% two-sided confidence intervals 
will be generated where appropriate. 
Resulting p-values will be provided and 95% two-sided 
confidence intervals will be generated where appropriate. 
Clarification 
2.0 
41 
Safety Analysis 
A listing of concomitant medications 
will be provided by subject for AEs, 
 
A listing of concomitant medications will be provided by 
subject. 
 
Clarification 
2.0 
42 
Other Endpoint 
Analysis 
The derivation of surgeon reported 
outcomes used in summarizing this 
data for the study will be described in 
the SAP and will be summarized as 
The derivation of surgeon reported outcomes used in 
summarizing this data for the study will be described in the 
SAP and will be summarized as appropriate using descriptive 
Clarification  

Study Protocol
Device
 
PMCF Study on PEEK Suture Anchors for Hip 
Indications 
Number: 2018.14.SMD.PEEK.RET.HIP 
Version: 2.0, 03 April 2019 
Page:  11 of 63 
 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is intended for use only by Smith & Nephew and its 
manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
SOP-059 Clinical Protocols 
 
Version  
 
Page 
Item 
Original 
New 
Reason 
appropriate using descriptive summary 
characteristics 
for 
continuous 
or 
categorical endpoints.  Differences from 
screening/baseline  to 6 months and 12 
months will be similarly summarized 
and/or compared.   
summary characteristics for continuous or categorical 
endpoints at 6 months and 12 months. 
 
2.0 
42 
 
Sample Size 
Justification 
With an assumption of a 91% clinical 
success rate to be obtained in each of 
the PEEK anchor sutures and a 
corresponding 95% CI between 80% 
and 100%, enrolling between 20 and 
40 subjects for each PEEK anchor 
s would 
provide between 15.2% to 71% 
probability.  Thus, an overall minimum 
of 40 and maximum of 80 subjects 
who had previously undergone surgery 
With an assumption of a 91% clinical success rate to be 
obtained in each of the PEEK anchor sutures and a 
corresponding 95% CI between 80% and 100%, enrolling 
between 20 and 120 subjects for each PEEK anchor 
precision analysis will provide between 15.2% to 95% 
probability.  Thus, an overall minimum of 40 and maximum of 
240 subjects who had previously undergone surgery of the 
hip using PEEK anchor sutures will be enrolled into the study. 
Additionally, a minimum of 20 subjects will be enrolled at any 
investigational site.   
 
Clarification 

Study Protocol
Device
 
PMCF Study on PEEK Suture Anchors for Hip 
Indications 
Number: 2018.14.SMD.PEEK.RET.HIP 
Version: 2.0, 03 April 2019 
Page:  12 of 63 
 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is intended for use only by Smith & Nephew and its 
manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
SOP-059 Clinical Protocols 
 
Version  
 
Page 
Item 
Original 
New 
Reason 
of the hip using PEEK anchor sutures 
would be enrolled into the study. 
Additionally, a minimum of 6 subjects 
would be enrolled at any 
investigational site.   
 
2.0 
43 
AE Definitions 
All adverse events will be captured. 
All adverse events will be captured from the time of surgery 
through the 12 month follow-up visit. 
Clarification 
2.0 
47 
Reporting 
Procedures 
AE of any kind and DevD will be 
recorded in the applicable CRF and 
source notes. The Investigator will 
evaluate all AE for relationship to the 
device and procedure, if applicable, 
seriousness, and severity. ADE, SAE, 
and DevD will be entered into the CRF 
and reported to the Sponsor within 24 
hours of the investigator being 
AE of any kind and DevD will be recorded in the applicable 
CRF and source notes. The Investigator will evaluate all AE for 
relationship to the device and procedure, if applicable, 
seriousness, and severity. ADE, SAE, and DevD will be 
entered into the CRF and reported to the Sponsor within 24 
hours of the investigator being informed about the event 
(Figure 1).   Applicable to the retrospective study design, 24 
hour reporting begins at the time the Investigator was 
informed of the event under the auspice of the clinical study.  
Clarification implemented 
as it is applicable for a 
retrospective study. 

Study Protocol
Device
 
PMCF Study on PEEK Suture Anchors for Hip 
Indications 
Number: 2018.14.SMD.PEEK.RET.HIP 
Version: 2.0, 03 April 2019 
Page:  13 of 63 
 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is intended for use only by Smith & Nephew and its 
manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
SOP-059 Clinical Protocols 
 
Version  
 
Page 
Item 
Original 
New 
Reason 
informed about the event (Figure 1).   
For ADE and DevD, details of the 
product/procedure related to the event 
will be included and where applicable, 
pictures taken of the device.  The 
deficient product should be retained for 
return to S&N unless it is contaminated 
(e.g. used dressings must not be 
retained). Updates to submitted 
information will be recorded in the CRF 
within 24 hours of the information 
being available to the investigator. 
For ADE and DevD, details of the product/procedure related 
to the event will be included and where applicable and 
available, pictures taken of the device.  If available, the 
deficient product should be retained for return to S&N unless 
it is contaminated (e.g. used dressings must not be 
retained).  
 
2.0 
N/A  
Follow-up of 
Subjects with 
Adverse Events  
For subjects who are experiencing 
ongoing unresolved AE at the time of 
their study completion or early 
discontinuation from the study, it is 
recommended that the Investigator 
Removed 
Clarification implemented 
as it is applicable for a 
retrospective study 

Study Protocol
Device
 
PMCF Study on PEEK Suture Anchors for Hip 
Indications 
Number: 2018.14.SMD.PEEK.RET.HIP 
Version: 2.0, 03 April 2019 
Page:  14 of 63 
 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is intended for use only by Smith & Nephew and its 
manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
SOP-059 Clinical Protocols 
 
Version  
 
Page 
Item 
Original 
New 
Reason 
schedule an appropriate follow-up visit 
in order to determine the outcome of 
the event.  
Any additional data must be 
documented and available to the 
Sponsor who will determine whether 
the data need to be documented within 
the CRF/Clinical Study Report. 
2.0 
N/A  
Ongoing 
Adverse Events 
at Study 
Discontinuation 
Adverse events which are related to a 
study procedure or S&N IP and are 
participation: The event should be 
followed until it is either resolved or 
until the event has become chronic and 
is not expected to further improve 
event. 
Removed 
Clarification implemented 
as it is applicable for a 
retrospective study 

Study Protocol
Device
 
PMCF Study on PEEK Suture Anchors for Hip 
Indications 
Number: 2018.14.SMD.PEEK.RET.HIP 
Version: 2.0, 03 April 2019 
Page:  15 of 63 
 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is intended for use only by Smith & Nephew and its 
manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
SOP-059 Clinical Protocols 
 
Version  
 
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Reason 
Adverse events which are not related 
to a study procedure or S&N IP and are 
participation should be followed for 30 
days after discontinuation or if the AE is 
resolved, whichever is sooner. 
 
At the time of data analysis (e.g. 
interim or final), an evaluation of 
ongoing events should take place and 
be listed as ongoing in the safety table. 
 
49 
Investigator 
Obligations 
(Financial 
Disclosure) 
In addition, the PI will ensure that the 
Financial Disclosure Statements will be 
completed by the PI and the Sub-
Investigator upon entry into the study 
and as any changes that affect their 
financial disclosure status occur during 
Removed  
Clarification- Financial 
disclosures is not 
applicable. 

Study Protocol
Device
 
PMCF Study on PEEK Suture Anchors for Hip 
Indications 
Number: 2018.14.SMD.PEEK.RET.HIP 
Version: 2.0, 03 April 2019 
Page:  16 of 63 
 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is intended for use only by Smith & Nephew and its 
manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
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the course of the study and up to one 
year after study completion. 
 
49 
Sponsor and 
Monitor 
Obligations 
The Sponsor will designate a monitor 
to conduct regular monitoring visits.  
The purpose of these visits are to 
ensure the wellbeing of the subjects 
are protected and that data is accurate, 
complete and verifiable from source 
documents.   
The Sponsor will designate a monitor to conduct regular 
monitoring visits.  The purpose of these visits are to ensure 
that data is accurate, complete and verifiable from source 
documents.   
 
Clarification implemented 
as it is applicable for a 
retrospective study 
 
50 
End of Study 
The end of study is defined as the date 
of the last subject, last visit (LSLV).    No 
additional care for subjects will be 
provided under the protocol will be 
provided once their participation in the 
study has ended.    
Should circumstances arise which 
require the termination of the entire 
The end of study is defined as the date of the last subject, 
last visit (LSLV).  No additional care for subjects will be 
provided under the protocol as this is a retrospective study.    
 
Should circumstances arise which require the termination of 
the entire study prior to its planned completion (e.g. safety 
concerns) or circumstances arise which mean the end of the 
participation of an individual site (e.g. departure of 
Clarification implemented 
as it is applicable for a 
retrospective study. 

Study Protocol
Device
 
PMCF Study on PEEK Suture Anchors for Hip 
Indications 
Number: 2018.14.SMD.PEEK.RET.HIP 
Version: 2.0, 03 April 2019 
Page:  17 of 63 
 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is intended for use only by Smith & Nephew and its 
manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
SOP-059 Clinical Protocols 
 
Version  
 
Page 
Item 
Original 
New 
Reason 
study prior to its planned completion 
(e.g. safety concerns) or circumstances 
arise which mean the end of the 
participation of an individual site (e.g. 
departure of Investigator, non-
compliance), then this will be 
undertaken according to the SOPs of 
the Sponsor. All reasonable efforts 
should be made to retain the subjects 
for the 12-month post-operative follow-
up of this study.  A study termination 
CRF needs to be completed for any 
subject that does not complete the 
study, to document the reason for 
termination. 
Investigator, non-compliance), then this will be undertaken 
according to the SOPs of the Sponsor.   
 

Study Protocol
Device
 
PMCF Study on PEEK Suture Anchors for Hip 
Indications 
Number: 2018.14.SMD.PEEK.RET.HIP 
Version: 2.0, 03 April 2019 
Page:  18 of 63 
 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is intended for use only by Smith & Nephew and its 
manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
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Version  
 
Page 
Item 
Original 
New 
Reason 
 
50 
Revision of the 
Study Device 
If a subject has bilateral implants and 
has a revision, the subject will be 
maintained in the study and both 
implants will continue to be followed 
per the protocol visit schedule 
If a subject has bilateral implants and has a revision, both 
implants will continue to be followed per the protocol visit 
schedule. 
 
Clarification implemented 
as it is applicable for a 
retrospective study. 

 
Study Protocol
Device 
PMCF Study on PEEK Suture Anchors for Hip 
Indications 
Number: 2018.14.SMD.PEEK.RET.HIP
Version: 2.0, 03 April 2019
Page:  19 of 63 
 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
SOP-059 Clinical Protocols 
 
 
 SPONSOR APPROVAL  
 
Job title 
DocuSign Stamp 
Sr. Vice President, Chief 
Medical Officer, Global 
R&D 
Weymann, Andy 
 
Head of Global Clinical 
Strategy 
  Hanson, Beate 
 
 
 
 
 
 
 
Head of Global 
Biostatistics and Data 
Management 
 
Rossington, Alan 
 
 
 
 
 
 
 
Medical Affairs 
Representative 
Orlandini, Luca 
 
 
 
 
 

 
Study Protocol
Device 
PMCF Study on PEEK Suture Anchors for Hip 
Indications 
Number: 2018.14.SMD.PEEK.RET.HIP
Version: 2.0, 03 April 2019
Page:  20 of 63 
 
 
CONFIDENTIAL AND PROPRIETARY 
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intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
SOP-059 Clinical Protocols 
 
 SYNOPSIS 
Title of Study: 
PMCF Study on PEEK Suture Anchors for Hip Indications 
Study Design: 
Multi-center, retrospective case series.  
Study Type: 
Post-market Clinical Follow-up 
Study Products: 
PEEK Suture Anchors for Hip 
*Part numbers as of September 2018 
 
Bioraptor Knotless 
Suture Anchor 
 72202397 
SpeedLock Hip Suture 
Anchor 
 
OM-7500 
 
Intended Use: 
The PEEK anchors are intended to be used for soft tissue to bone fixation in the 
hip following hip capsule repair. 
Study Purpose: 
Assess safety and performance post-market of the PEEK suture anchor devices 
to address clinical data gaps for MDR. 
Primary Outcome: 
Evidence of safety and performance of the PEEK suture anchor devices in the 
hip. 
Statistical Rationale: 
The sample size for this study is determined based on the feasibility of 
recruitment, enrolment and follow-up considerations. The study is therefore not 
powered for any statistical hypothesis testing but will be able to estimate a 
clinical success rate of 91% with a 95% confidence interval (CI) of 80% to 100%. 
 
Sample Size: 
Minimum number of subjects, n=40  
Maximum number of subjects, n=240 
Enrollment distribution: 
Up to three sites will enroll a maximum of 40 subjects per anchor configuration 
therefore no more than 120 subjects will be enrolled for any anchor type. 
 
 

 
Study Protocol
Device 
PMCF Study on PEEK Suture Anchors for Hip 
Indications 
Number: 2018.14.SMD.PEEK.RET.HIP
Version: 2.0, 03 April 2019
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CONFIDENTIAL AND PROPRIETARY 
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intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
SOP-059 Clinical Protocols 
 
PEEK Anchor 
Minimum 
Number of 
Subjects/Site 
Maximum 
Number of 
Subjects/Site 
Maximum 
Number of 
Subjects for 
the Study 
Bioraptor Knotless 
Suture Anchor 
20 subjects per 
site 
40 subjects per 
site 
120 subjects 
SpeedLock Hip 
 
20 subjects per 
site 
40subjects per 
site 
120 subjects 
Total 
40 subjects  
80 subjects 
240 subjects 
 
Number of Study 
Sites: 
Up to 6 sites 
Targeted Global 
Regions: 
USA 
Inclusion Criteria: 
1.  Subjects who have undergone hip joint repair using the study devices.  
2. Subjects aged 18 years and older at the time of surgery. 
3. Subjects must have had a visit to their provider between 6 and 15 
months post-operative. 
Exclusion Criteria: 
1. Subjects who are < 12 months post-operative. 
2. Subject is entered in another investigational drug, biologic, or device 
study or has been treated with an investigational product within 30 days 
prior to surgery. 
3. Subject had off-label use of the PEEK suture anchor during surgery. 
Study Duration: 
Twelve month follow-up 
Primary Endpoint: 
Clinical success rate (%) at 6 months post-operative based on standard of care 
Secondary 
Endpoint: 
Clinical success rate (%) at 12 months post-operative based on standard of care 
Exploratory 
Outcomes: 
Surgeon Reported Outcomes based on data collected on 
chart as standard of care at study sites. These may include but not restricted to 
the following: 

 
Study Protocol
Device 
PMCF Study on PEEK Suture Anchors for Hip 
Indications 
Number: 2018.14.SMD.PEEK.RET.HIP
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CONFIDENTIAL AND PROPRIETARY 
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intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
SOP-059 Clinical Protocols 
 
 
Range of Motion (ROM)  
 
Flexion 
 
Extension 
 
Abduction 
 
Adduction 
 
External/Internal Rotation 
 
 
Pain assessed by VAS 
Safety Endpoints: 
 
All AEs, SAEs and complications including intra-operative adverse 
events and complications. 
 
Device related intervention 
 
Device deficiency 
 
 
 

 
Study Protocol
Device 
PMCF Study on PEEK Suture Anchors for Hip 
Indications 
Number: 2018.14.SMD.PEEK.RET.HIP
Version: 2.0, 03 April 2019
Page:  23 of 63 
 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
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 SCHEDULE OF EVENTS 
Table 1:  Schedule of Events 
Schedule of Events 
Chart Review 
182 days  post-op 
6M (±91 Days) 
365 days post-op 
12M (± 91 Days ) 
Informed Consent  
X 
NA if waiver of consent granted  by 
IRB 
 
Inclusion/Exclusion 
X 
 
Demographics/Medical 
History 
X 
 
VAS, ROM 
X 
X 
Operative Data Collection 
X 
 
Implant Status and / or 
Disposition 
X 
X 
Concomitant Medications 
or Therapies1 
X 
X 
AE, SAE and DevD 
Assessment 
X 
X 
End of Study 
 
X2 
 
 
                                                     
1 Any concomitant medications associated with an AE, SA(D)E will be recorded. 
2  End of Study CRF can be completed at 6 months if the subject did not have a 12-month visit. 

 
Study Protocol
Device 
PMCF Study on PEEK Suture Anchors for Hip 
Indications 
Number: 2018.14.SMD.PEEK.RET.HIP
Version: 2.0, 03 April 2019
Page:  24 of 63 
 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
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  TABLE OF CONTENTS 
 
Signatures ............................................................................................................................. 2 
1.1 
Protocol Signature Page ................................................................................................ 2 
 
Revision History, Ownership, and Approvals: ....................................................................... 3 
2.1 
Revision History ............................................................................................................. 3 
 
Sponsor Approval ................................................................................................................ 19 
 
Synopsis ............................................................................................................................. 20 
 
Schedule of events ............................................................................................................. 23 
 
Table of Contents ................................................................................................................ 24 
 
List of Abbreviations ........................................................................................................... 27 
 
Introduction ......................................................................................................................... 29 
8.1 
Study Purpose ............................................................................................................. 30 
8.2 
Safety Considerations ................................................................................................. 30 
 
Objective ............................................................................................................................. 30 
9.1 
Primary Objective ........................................................................................................ 30 
 
Study Product(s) ................................................................................................................... 31 
10.1 
 ........................................................................... 31 
10.2 
SpeedLock Hip Suture Anchor .................................................................................... 32 
10.3 
Indications ................................................................................................................... 32 
10.4 
Product Use ................................................................................................................. 33 
 
Subject Enrollment and Withdrawal .................................................................................... 33 
11.1 
Subject Population ....................................................................................................... 33 
11.2 
Inclusion Criteria .......................................................................................................... 33 
11.3 
Exclusion Criteria ......................................................................................................... 34 
11.4 
Screening .................................................................................................................... 34 
11.5 
Informed Consent ........................................................................................................ 34 

 
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PMCF Study on PEEK Suture Anchors for Hip 
Indications 
Number: 2018.14.SMD.PEEK.RET.HIP
Version: 2.0, 03 April 2019
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CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
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11.6 
Enrollment .................................................................................................................... 35 
11.7 
Lost to Follow-Up ......................................................................................................... 35 
11.8 
Withdrawal ................................................................................................................... 35 
 
Study Design ....................................................................................................................... 36 
12.1 
Study Design ............................................................................................................... 36 
12.2 
Allocation and Blinding ................................................................................................ 36 
12.3 
Study Endpoints........................................................................................................... 37 
 
Study Procedures ................................................................................................................ 38 
13.1 
6 months Post-Op Chart  Review ................................................................................ 38 
13.2 
12 months post-op Chart Review ................................................................................ 39 
13.3 
Concomitant Medications and Therapies .................................................................... 39 
 
Statistical Design ................................................................................................................ 39 
14.1 
General ........................................................................................................................ 39 
14.2 
Analysis Populations ................................................................................................... 40 
14.3 
Efficacy Analysis .......................................................................................................... 40 
14.4 
Safety Analyses ............................................................................................................ 41 
14.5 
OTHER ENDPOINT Analyses ........................................................................................ 42 
 
Sample Size Justification .................................................................................................... 42 
 
Adverse Events and Device Deficiencies ............................................................................ 43 
16.1 
Definitions ................................................................................................................... 43 
16.2 
Reporting Procedures .................................................................................................. 47 
 
Investigator Obligations ...................................................................................................... 49 
 
Sponsor and Monitor Responsibilities ................................................................................ 49 
 
Protocol Amendments ........................................................................................................ 49 
 
Confidentiality of the Study ................................................................................................. 49 
 
Statements of Compliance .................................................................................................. 49 

 
Study Protocol
Device 
PMCF Study on PEEK Suture Anchors for Hip 
Indications 
Number: 2018.14.SMD.PEEK.RET.HIP
Version: 2.0, 03 April 2019
Page:  26 of 63 
 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
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End of Study ........................................................................................................................ 50 
 
Revision of the Study Device .............................................................................................. 50 
 
Publication Policy ................................................................................................................. 51 
24.1 
Publication of Study Data ............................................................................................. 51 
24.2 
Data Sharing ................................................................................................................. 51 
 
References .......................................................................................................................... 52 
 
Appendices ......................................................................................................................... 53 
26.1 
Principal Investigator Obligations (ISO14155) .............................................................. 53 
 
TABLES  
Table 1:  Schedule of Events .......................................................................................................... 23 
Table 2:  Instructions for Use Reference Numbers ........................................................................ 30 
Table 3:  Part Numbers ................................................................................................................. 32 
Table 4:  Enrollment ....................................................................................................................... 36 
Table 5:  Categories of Adverse Events ........................................................................................ 44 
 
FIGURES 
 
Figure 1:  Evaluation and Reporting of AE and DevD ..................................................................... 48 
 
 

 
Study Protocol
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PMCF Study on PEEK Suture Anchors for Hip 
Indications 
Number: 2018.14.SMD.PEEK.RET.HIP
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CONFIDENTIAL AND PROPRIETARY 
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intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
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 LIST OF ABBREVIATIONS  
Abbreviation 
 Term 
ABHI 
Association of British Healthcare Industries 
ABS 
Acrylonitrile Butadiene Styrene 
ADE 
Adverse Device Effect(s) 
AE 
Adverse Event(s) 
ASADE 
Anticipated Serious Adverse Device Effect 
CFR 
Code of Federal Regulations 
CI 
Confidence Interval 
CRF 
Case Report Form(s) 
CSR 
Clinical Study Report 
CTA 
Clinical Trial Agreement 
CV 
Curriculum Vitae 
DevD 
Device Deficiency(ies) 
GCP 
Good Clinical Practice 
HHS 
Health and Human Services 
ICH 
International Conference on Harmonisation  
ICMJE 
International Committee of Medical Journal Editors 
IEC 
International Ethics Committee 
IFU 
Instructions for Use 
IP 
Investigational Product 
IRB 
Institutional Review Board 
ISF 
Investigator Site File 
ISO 
International Organization for Standardization 
LSLV 
Last subject, last visit 

 
Study Protocol
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PMCF Study on PEEK Suture Anchors for Hip 
Indications 
Number: 2018.14.SMD.PEEK.RET.HIP
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CONFIDENTIAL AND PROPRIETARY 
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intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
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Abbreviation 
 Term 
MDR 
Medical Device Regulation 
N (or n) 
Total Sample Size (or subgroup sample size) 
NA or N/A 
Not Applicable 
PEEK / PK 
Polyetheretherketone 
PI 
Principal Investigator 
PMCF 
Post-market Clinical Follow-up 
PP 
Per-protocol Population 
ROM 
Range of Motion 
S&N 
Smith & Nephew Inc. 
SADE 
Serious Adverse Device Effect(s) 
SAE 
Serious Adverse Event(s) 
SAF 
Safety Population 
SAP 
Statistical Analysis Plan 
USADE 
Unanticipated Serious Adverse Device Effect(s) 
VAS 
Visual Analogue Scale 

 
Study Protocol
Device 
PMCF Study on PEEK Suture Anchors for Hip 
Indications 
Number: 2018.14.SMD.PEEK.RET.HIP
Version: 2.0, 03 April 2019
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CONFIDENTIAL AND PROPRIETARY 
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intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
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INTRODUCTION 
Suture anchors are small fixation devices used in surgical procedures for attaching or reattaching 
tendons and ligaments 
bone density and the procedure performed. 
Suture anchors are made of three components: the anchor which is inserted into the bone; the 
eyelet  which is a hole or a loop in the anchor that the suture passes through to link the anchor 
to the suture; and the suture  which is attached to the anchor through the eyelet of the anchor.  
An anchor- receiving hole is first drilled in the bone at the desired point of tissue reattachment.  
A suture anchor is deployed in the hole using an appropriate installation tool.  This effectively 
locks the suture to the bone, with the free end(s) of the suture extending out the bone.  Soft 
tissue is then moved into position over the hole containing the deployed suture anchor.  As this 
is done, the free end(s) of the suture is (are) passed through or around the soft tissue so that the 
free end(s) of the suture reside(s) on the far (i.e., non-bone) side of the soft tissue.  The suture is 
now used to tie the soft tissue securely to the bone. 
Smith & Nephew offers a variety of suture anchors including several polyetheretherketone (PEEK) 
suture anchors soft tissue to bone repair.  The PEEK devices included in study are all single use, 
sterile devices comprised of machined component anchor bodies that are manufactured from 
PEEK-OPTIMA Polymer (LT1).  This material meets ISO 10993 biocompatibility requirements for 
implant devices, bone/tissue contact and permanent contact.  The anchor tips are molded 
components which are also manufactured from PEEK-OPTIMA Polymer (LT3).  PEEK-OPTIMA 
polymers provide an ideal combination of strength, biocompatibility, reviseability and inherent 
radiolucent characteristics.  Smith & Nephew also provides a variety of reusable and disposable 

 
Study Protocol
Device 
PMCF Study on PEEK Suture Anchors for Hip 
Indications 
Number: 2018.14.SMD.PEEK.RET.HIP
Version: 2.0, 03 April 2019
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CONFIDENTIAL AND PROPRIETARY 
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intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
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instrumentation used in conjunction with the suture anchors including awls, dilators, drills, 
guides, obturators and wires. 
8.1 STUDY PURPOSE 
The purpose of this study is to conduct post-market clinical follow-up regarding the safety and 
performance of the PEEK anchors as required per MDR.  
8.2 SAFETY CONSIDERATIONS 
 Refer to the IFUs. 
Table 2:  Instructions for Use Reference Numbers 
Instructions for use document numbers have been provided as a reference but may not have 
been the version used at the time of surgery. 
 
PEEK Suture Anchor 
IFU 
Bioraptor Knotless Suture Anchor 
10600479 2/17, Rev E 
SpeedLock Hip Suture Anchor 
P/N 62513 March 2017, Rev B 
 
 
OBJECTIVE 
9.1 PRIMARY OBJECTIVE  
The primary objective of this study is to assess safety and performance post-market of the PEEK 
anchor devices in the hip. 
 
 
 
 
 
 

 
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Number: 2018.14.SMD.PEEK.RET.HIP
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intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
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 STUDY PRODUCT(S) 
10.1  
 KNOTLESS SUTURE ANCHOR 
 
 
-in anchor that is manufactured 
from PEEK-OPTIMA® from Invibio®. The anchor is pre-assembled on an inserter comprised of a 
stainless steel shaft and an ABS and polycarbonate handle. The anchor is sized appropriately to 
facilitate both hip and shoulder procedures. The design consists of an outer anchor body and an 
inner shaft plug. The ribbed anchor, loaded with suture tails, is tapped into a pre-drilled prepared 
hole. The surgeon is now able to reapproximate the tissue to the appropriate tension and then use 
the torque-limiting knob on the insertion device that moves the inner plug down to lock the plug 
and achieve a secure fixation. 
 
 
 
 

 
Study Protocol
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Indications 
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CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
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10.2  SPEEDLOCK HIP SUTURE ANCHOR 
 
 
 
The SpeedLock Knotless Fixation Device is an implant that facilitates the attachment of tissue to 
bone. The SpeedLock system consists of a fixation device pre-loaded with a suture snare in an 
inserter handle. The SpeedLock implant is a knotless fixation device, in other words surgical 
knots are not necessary for fixation of suture to tissue. 
10.3  INDICATIONS 
 
The Smith & Nephew PEEK anchors are intended to be used for soft tissue to bone fixation in the 
hip following hip capsule repair.  
Table 3:  Part Numbers 
Peek Suture Anchors for the Hip 
 
*Part numbers as of September 2018 
 
Bioraptor Knotless Suture Anchor 
 72202397 
SpeedLock Hip Suture Anchor 
OM-7500 
 

 
Study Protocol
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PMCF Study on PEEK Suture Anchors for Hip 
Indications 
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intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
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10.4  PRODUCT USE 
All study related procedures using the PEEK suture anchors in the hip have been performed 
according to the recommended surgical technique described in the labelling and the instructions 
for use.  
 SUBJECT ENROLLMENT AND WITHDRAWAL 
Investigators will screen all subjects that have undergone usage of the PEEK suture anchors in 
the hip using only the existing information in the medical records.  
 
Investigators will conduct a chart review after IRB approval has been granted.  All subjects whose 
chart undergoes the screening process will be documented on a Screening and Enrollment Log, 
with the reason for exclusion noted, if applicable. The Investigator or designee must notify the 
Sponsor upon subject enrollment. 
11.1  SUBJECT POPULATION 
To minimize the potential for selection bias, Investigators will screen and subsequently enroll 
subjects (after fulfilling all inclusion and exclusion criteria) on whom PEEK suture anchors in the 
hip were implanted. Enrollment will be in sequential order based on the date of their surgical 
procedure with the investigational device, i.e. time of surgery to present day. 
11.2  INCLUSION CRITERIA 
Subjects will be considered qualified for enrollment if they meet the following criteria: 
1. Subjects who have undergone hip joint repair using the study devices.  
2. Subjects aged 18 years and older at the time of surgery. 

 
Study Protocol
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contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
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3. Subjects must have had a visit to their provider between 3 and 15 months post-operative. 
11.3  EXCLUSION CRITERIA 
Any one (1) of the following criteria will disqualify a potential subject from participation in 
the study: 
 
1. Subjects who are < 12 months post-operative. 
2. Subject is entered in another investigational drug, biologic, or device study or has been 
treated with an investigational product within 30 days prior to surgery.  
3. Subject had off-label use of the PEEK suture anchor during surgery. 
11.4  SCREENING  
Participating study sites are required to document all screened subjects considered for inclusion 
in this study. If a subject is excluded from the study, the reasons for exclusion will be 
documented in the subject's source documents and noted on the Screening and Enrollment Log.  
11.5  INFORMED CONSENT 
For adults and children, a waiver or alteration of the requirements for obtaining informed consent 
can occur under any of the following three provisions set forth by HHS: 
Research in general: an IRB may waive or alter the requirement of informed consent under 45 
CFR 46.116(d), provided that the IRB finds and documents that all of the following four conditions 
are met: [3] 
1. the research involves no more than minimal risk to the participants; 
2. the waiver or alteration will not adversely affect the rights and welfare of the participants; 

 
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CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
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3. the research could not practicably be carried out without the waiver or alteration; and 
4. whenever appropriate, the participants will be provided with additional pertinent information   
after  participation. 
11.6  ENROLLMENT 
Enrollment in this study shall occur when subjects have meet inclusion criteria and none of the 
exclusion criteria.  When a subject is enrolled for the left hip as well as the right hip, only one 
subject ID will be allocated. 
11.7  LOST TO FOLLOW-UP 
Not applicable. 
11.8  WITHDRAWAL 
11.8.1 Withdrawal from the Study 
The Investigator may withdraw subjects from the study for many reasons, including but not limited 
to the following: 
 At the discretion of the Investigator. 
 If the Investigator or the Sponsor stops the study for any reason and decides to withdraw 
subject(s) from the study. 
 
For each case, information will be documented in the source document and the Case Report 
Form (CRF), detailing circumstances leading to the withdrawal.  
 
Subjects who are withdrawn will not be re-entered into the study at a later date.  Data collected 
up to the point of withdrawal may be used but no additional data for that subject may be 
collected.  

 
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contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
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 STUDY DESIGN 
12.1  STUDY DESIGN 
This is a retrospective, open-label, multi-center study to collect clinical data that will evaluate 
post-market safety and performance of the PEEK suture anchors in the hip.  A minimum of 40 
subjects and a maximum of 240 subjects in the United States who underwent surgery in the hip 
using the Smith & Nephew PEEK suture anchors are planned to be enrolled into the study after 
the fulfilment of all inclusion and exclusion criteria.  Up to three sites will enroll a minimum of 20 
subjects and a maximum of 40 subjects per anchor configuration; therefore, not more than 120 
subjects will be enrolled for any anchor type.  
 
Data obtained from enrolled eligible subjects will subsequently be recorded on case report forms.  
 
Table 4:  Enrollment 
PEEK Anchor 
Minimum Number of 
Subjects/Site 
Maximum Number 
of Subjects/Site 
Maximum Number of 
Subjects for the Study 
Bioraptor Knotless 
Suture Anchor 
20 subjects per site 
40 per site 
120 subjects 
SpeedLock Hip 
 
20 subjects per site 
40 per site 
120 subjects 
Total 
40 subjects 
80 subjects 
240 subjects 
 
12.2  ALLOCATION AND BLINDING 
This study is not randomized or blinded. 

 
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12.3  STUDY ENDPOINTS 
12.3.1 Primary Endpoint 
The primary endpoint will be clinical success rate (%) at 6 months post-operative based on 
standard of care. Clinical success is defined as hip repairs without signs of device failure and/or 
re-intervention as assessed by the surgeon. 
12.3.2 Secondary Endpoints  
The secondary endpoint will be clinical success rate (%) at 12 months post-operative based on 
standard of care.  Clinical success has previously been defined.   It is expected that per 
s standard of care, 12 month clinical data will be consistently be available. 
12.3.3 
Safety Endpoints 
Safety endpoints will include but not restricted to the following events: 
 All adverse events, SAEs and complications occurring from the time of enrollment until 
study termination or study completion including intra-operative adverse events and 
complications. 
 Device related intervention. 
 Device deficiency. 
12.3.4 
Other Endpoints 
Surgeon Reported Outcomes would constitute other endpoints and may include but not 
restricted to the following: 
 Range of Motion (ROM)  
 Flexion 
 Extension 

 
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 Abduction 
 Adduction 
 External/Internal Rotation 
 
 Pain assessed by VAS 
 
 STUDY PROCEDURES 
13.1  6 MONTHS POST-OP CHART  REVIEW 
NOTE: Any subject, who meets the inclusion/exclusion criteria, will be assigned a subject 
number. 
 
1. Subject should undergo the informed consent process and sign the informed consent 
only if a waiver of consent has not been approved by the IRB. 
2. Screen the subject
 for protocol inclusion/exclusion criteria.   
3. Obtain demographic information and a medical history. 
4. VAS, ROM. 
5. Operative Data Collection  review operative case notes. 
6. Implant Status / Disposition. 
7. Document concomitant medications and/or therapies associated with an AE, SA(D)E 
8. Review t
nd Device Deficiencies, including inter-
operative.  AEs, SAEs and DevDs should be documented from the time of surgery 
through the study duration. 
 

 
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contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
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13.2  12 MONTHS POST-OP CHART REVIEW 
1.  VAS, ROM 
2. Implant Status/Disposition 
3. Document concomitant medications and/or therapies associated with an AE, SA(D)E 
4. Review th
s, SAEs and Device Deficiencies including inter-operative.  
AEs, SAEs and DevDs should be documented from the time of surgery through the study 
duration. 
5. Complete the End of Study CRF. 
13.3  CONCOMITANT MEDICATIONS AND THERAPIES 
Any concomitant medications associated with an AE, SAE or SADE will be recorded.  Concomitant 
medications will be recorded from the time of surgery through 
visit occurred at 6 months, concomitant medications will be collect through 6 months. 
 STATISTICAL DESIGN 
A Statistical Analysis Plan (SAP) will be written and finalized prior to database lock. The analyses 
specified in the protocol will be a microcosm of the detailed analyses to be contained in the SAP. 
If there are changes to or additional analyses required to the analysis described below, it will be 
described in the SAP and the Clinical Study Report (CSR).  
14.1  GENERAL 
 or designee will conduct the statistical analysis for 
this study. Unless otherwise stated, all significance tests will be two-sided, performed at the 5% 

 
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significance level. Resulting p-values will be provided and 95% two-sided confidence intervals 
will be generated where appropriate.  
 
Where data summaries are specified, categorical and ordinal variables will be summarized with 
frequencies and percentages. Continuous variables will be summarized with the following 
summary statistics: number of observations, mean, median, standard deviation, minimum and 
maximum values. All analyses will be performed in SAS version 9.3 (or later). 
14.2  ANALYSIS POPULATIONS 
 The following analysis populations will be used for this study: 
 Safety Population (SAF): This includes all subjects who enroll in the study who had 
previously undergone hip repair using PEEK suture anchors, i.e. subjects who would 
provide retrospective data.  
 Per-Protocol Population (PP): This includes all subjects in the Safety Population, who 
have no significant protocol deviations and who meet all the inclusion/exclusion criteria. 
14.3  EFFICACY ANALYSIS 
14.3.1 Analysis of Primary Endpoint 
The rate (%) of clinical success of all the PEEK suture anchor devices combined at 6 months post-
operative will be summarized as a frequency and percentage. A 95% two-sided exact CI for a 
single proportion will be presented using Clopper-
 [1]. The same type analysis 
would be carried out for each of the 2 different PEEK suture anchors used in the study.  These 

 
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contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
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analyses will be carried out using the per protocol population as the primary analysis population 
with the safety population used for sensitivity analysis.  
14.3.2 
Analysis of Secondary Endpoints 
The analysis of the following secondary endpoint will be carried out using the safety population.  
o The rate (%) of clinical success of all the PEEK suture anchors combined at 12 months 
post-operative  will be summarized as described for the analysis of the primary endpoint. 
This analysis will also be repeated for each of the 2 different types of PEEK suture 
anchors used in the study.   
14.4  SAFETY ANALYSES 
o All safety endpoints will be summarized using the safety population. The incidence of 
events encountered on study will be summarized using frequencies and percentages.  
An overall AE table will be summarized using the overall incidence according to subjects 
with at least one AE; subjects with at least one AE by worst severity (mild, moderate, or 
severe); subjects with at least one AE by worst outcome; subjects with one AE that led to 
study discontinuation; subjects with at least one AE by relatedness to investigational 
device; SAEs; ADEs; ASADEs; USADEs and SADEs as applicable.  A cumulative summary 
by the number of events encountered within each classification will also be summarized. 
The incidence of subjects reporting device deficiencies will additionally be summarized. 
o Each of the AE classifications will further be summarized by event using the frequencies 
(n) and percentages (%) of subjects with each event as well as the ccumulative 
events/episodes per event.  
o A listing of concomitant medications will be provided by subject. 

 
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contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
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Additional summaries of safety endpoints, if applicable, will be described in the SAP. 
14.5  OTHER ENDPOINT ANALYSES 
o The analyses of other endpoints will be carried out using the safety population. Overall, 
device-related failure and device-related re-intervention encountered on-study will be 
summarized independently as frequencies and percentages. A 95% two-sided exact CI 
for a single proportion will be presented for each proportion using Clopper-
s 
method (1934). 
o The derivation of surgeon reported outcomes used in summarizing this data for the study 
will be described in the SAP and will be summarized as appropriate using descriptive 
summary characteristics for continuous or categorical endpoints at 6 months and 12 
months 
13.6  Interim Analyses 
Not applicable 
 SAMPLE SIZE JUSTIFICATION 
This study is precision-based, as a result, the sample size is not based on statistical power 
calculations.   
The sample size for this study is determined based on the feasibility of recruitment, enrollment 
and follow-up considerations. The study is therefore not powered for any statistical hypothesis 
testing but will be able to estimate a clinical success rate of 91% with a 95% confidence interval 
(CI) of 80% to 100%. 

 
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contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
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 With an assumption of a 91% clinical success rate to be obtained in each of the PEEK anchor 
sutures and a corresponding 95% CI between 80% and 100%, enrolling between 20 and 120 
subjects for each PEEK anchor suture  precision analysis will provide between 15.2% to 95% 
probability.  Thus, an overall minimum of 40 and maximum of 240 subjects who had previously 
undergone surgery of the hip using PEEK anchor sutures will be enrolled into the study. 
Additionally, a minimum of 20 subjects will be enrolled at any investigational site.   
 
 ADVERSE EVENTS AND DEVICE DEFICIENCIES 
16.1  DEFINITIONS 
The categories of adverse events are shown in Table 4. The definitions for each of these 
categories are given in the subsequent sections (see reference within the table).   All adverse 
events will be captured from the time of surgery through the 12-month follow-up visit.  
 
 
 
[Intentionally left blank] 
 
 
 
 
 
 

 
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contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
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Table 5:  Categories of Adverse Events 
 
NOT DEVICE-
RELATED 
DEVICE- OR PROCEDURE-RELATED 
NON-
SERIOUS 
ADVERSE EVENT  
(AE)  
ADVERSE DEVICE EFFECT  
(ADE)  
SERIOUS 
SERIOUS ADVERSE 
EVENT  
(SAE)  
 
SERIOUS ADVERSE DEVICE EFFECT 
(SADE) 
 
ANTICIPATED
UNANTICIPATED
ANTICIPATED SERIOUS 
ADVERSE DEVICE EFFECT  
(ASADE)  
UNANTICIPATED SERIOUS 
ADVERSE DEVICE EFFECT  
(USADE)  
16.1.1 Adverse Event 
An Adverse Event (AE) is any untoward medical occurrence temporally associated with the use of 
an IP/Ancillary Product, whether or not considered causally related to that IP/Ancillary Product.  
AE is used both to refer to AE which are non-serious non-IP or procedure-related and as an 
umbrella term referring to adverse events of all classifications.  
 
An AE can be any unfavorable and unintended sign (for example, an abnormal laboratory 
finding), symptom, or disease. For reporting purposes, emphasis is placed first and foremost on 
whether or not the event constitutes an untoward medical occurrence.  
16.1.2 Adverse Device Effect 
An Adverse Device Effect (ADE) is an adverse event that, in the opinion of the investigator, is 
related to the IP or the procedure.  

 
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contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
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Not Related -  An AE is considered to be not related to the use of an IP or the procedure when 
the effect is DEFINITELY UNRELATED or UNLIKELY to have any relationship to the 
use of the IP or the procedure. 
Related   An AE is considered to be related to the use of an IP or the procedure when there is a 
POSSIBLE, PROBABLE, or DEFINITE relationship between the AE and the use of the IP 
or the procedure. 
16.1.3 Serious Adverse Events and Serious Adverse Device Effects  
An AE or ADE is considered a Serious Adverse Event (SAE) or Serious Adverse Device Effects 
(SADE) if, in the view of either the Investigator or the Sponsor, it: 
 Results in death. 
 Is life-threatening (NOTE
-
to an event/reaction in which the subject was at risk of death at the time of the 
event/reaction; it does not refer to an event/ reaction which hypothetically might have 
caused death if it were more severe). 
 Requires in subject hospitalization or results in prolongation of existing hospitalization. 
 Results in persistent or significant incapacity or substantial disruption of the ability to 
conduct normal life functions. 
 Is a congenital anomaly/birth defect. 
 Is a medically important event or reaction. 
Medical and scientific judgment should be exercised in deciding whether other situations should 
be considered serious such as important medical events that might not be immediately life 

 
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contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
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threatening or result in death or hospitalization but might jeopardize the subject or might require 
intervention to prevent one of the other outcomes listed in the definition above. Examples of such 
events are intensive treatment in an emergency room or at home for allergic bronchospasm, 
blood dyscrasias, or convulsions that do not result in hospitalization, or development of drug 
dependency or drug abuse. 
16.1.4 Anticipated/Unanticipated Serious Adverse Device Effect 
An Unanticipated Serious Adverse Device Effect (USADE) is a serious ADE that meets any of the 
above definitions but is also considered, by the Investigator, to be caused by or related to the IP, 
not previously identified in nature, severity or degree in the IFU.    
 
An Anticipated Serious Adverse Device Effect (ASADE) is a serious ADE that does not meet the 
criteria for a USADE.  
16.1.5 Severity  
The severity of every AE will be assessed by the PI or medically qualified site staff to whom the 
responsibility has been delegated and documented on the delegation of authority log. AE should 
be classified as mild, moderate, or severe, regardless of whether or not the AE are considered to 
be serious or non-serious. The classification should be based on the following definitions: 
Mild  
- 
An event is mild if the subject is aware of, but can easily tolerate the sign or 
symptom. 
Moderate - 
An event is moderate if the sign or symptom results in discomfort significant 
enough to cause interference with 
 

 
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Severe -    
An event is severe if the sign or symptom is incapacitating and results in the 
inability to work or engage in their usual activities. 
16.1.6 Device Deficiency 
A Device Deficiency (DevD) is an inadequacy of a medical device with respect to its identity, 
quality, durability, reliability, safety or performance. DevD includes malfunctions, use errors and 
inadequate labelling.  
16.2  REPORTING PROCEDURES 
AE of any kind and DevD will be recorded in the applicable CRF and source notes. The 
Investigator will evaluate all AE for relationship to the device and procedure, if applicable, 
seriousness, and severity. ADE, SAE, and DevD will be entered into the CRF and reported to the 
Sponsor within 24 hours of the investigator being informed about the event (Figure 1). Applicable 
to the retrospective study design, 24 hour reporting begins at the time the Investigator was 
informed of the event under the auspice of the clinical study.  For ADE and DevD, details of the 
product/procedure related to the event will be included and where applicable and available, 
pictures taken of the device. If available the deficient product should be retained for return to 
S&N unless it is contaminated (e.g. used dressings must not be retained).  
 
All SAE and ADE will be reviewed by a medically qualified person appointed by the Sponsor to 
determine which, if any, meet criteria for expedited reporting to the regulatory authorities.  The 
investigator will inform the IRB/IEC of adverse events according to the IRB/IEC requirements. 
Depending on the nature of the adverse event, S&N 
records, imaging, operative notes, as well as results of any relevant laboratory tests performed or 

 
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other documentation related to the AE. If the subject was hospitalized, a copy of the discharge 
summary may be requested by S&N and should be forwarded as soon as it becomes available. 
In certain cases, S&N also may request a letter from the Investigator that summarizes the events 
related to the case. 
Figure 1:  Evaluation and Reporting of AE and DevD 
 
 
 
 

 
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Reference the ISF Sponsor Contact Information Sheet to report SAE, unanticipated ADE and 
SADE, anticipated SADE, and DevD. 
 INVESTIGATOR OBLIGATIONS 
The Principal Investigator will comply with the commitments outlined in the Statement of 
Investigator, provided by the Sponsor, and with Good Clinical Practice (GCP), and all applicable 
regulatory requirements as outlined in Section 26.1 of this protocol. 
 SPONSOR AND MONITOR RESPONSIBILITIES 
The Sponsor will designate a monitor to conduct regular monitoring visits.  The purpose of these 
visits are to ensure that data is accurate, complete and verifiable from source documents.   
 PROTOCOL AMENDMENTS 
Amendments should be made only in exceptional cases once the study has started. Protocol 
amendments must be approved by the protocol signatories prior to submission to the IRB.  
Protocol amendments need to be approved by the IRB and Regulatory Authority (ies), as 
applicable prior to implementation at the site. 
 CONFIDENTIALITY OF THE STUDY 
The confidentiality of this study and associated documents is governed by the terms of the 
Clinical Trial Agreement (CTA). 
 STATEMENTS OF COMPLIANCE 
This clinical study will be performed in compliance with the ethical principles of the Declaration of 
Helsinki; ISO 14155: Clinical investigation of medical devices  Good Clinical Practice and ICH-E6. 

 
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This clinical study will not commence until the required approval/favorable opinion from the IRB 
or regulatory authority has been obtained. Any additional requirements imposed by the IRB or 
regulatory authority will be followed.  
 
Public/Products Liability Insurance has been purchased by Smith & Nephew plc. Worldwide and 
incorporates coverage for personal injury in respect of clinical studies. The Sponsor agrees to 
operate in good faith and in accordance with ABHI (Association of British Healthcare Industries) 
guidelines regarding compensation for injury arising in the course of clinical studies. 
 END OF STUDY 
The end of study is defined as the date of the last subject, last visit (LSLV).    No additional care 
for subjects will be provided under the protocol, as this is a retrospective study.  
 
Should circumstances arise which require the termination of the entire study prior to its planned 
completion (e.g. safety concerns) or circumstances arise which mean the end of the participation 
of an individual site (e.g. departure of Investigator, non-compliance), and then this will be 
undertaken according to the SOPs of the Sponsor.  
 REVISION OF THE STUDY DEVICE 
If a subject has bilateral implants and has a revision, both implants will continue to be followed 
per the protocol visit schedule. 
 

 
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CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
SOP-059 Clinical Protocols 
 
 PUBLICATION POLICY 
24.1  PUBLICATION OF STUDY DATA 
The preparation and submission for publication of manuscripts containing the study results shall 
be in accordance with a process determined by the Clinical Trial Agreements between the study 
Sponsor and participating institutions. The publication or presentation of any study results shall 
comply with all applicable privacy laws, including, but not limited to the Health Insurance 
Portability and Accountability Act of 1996. 
24.2  DATA SHARING 
Smith & Nephew is committed to upholding the highest ethical and legal standards involved in 
conducting clinical trials. Smith & Nephew therefore supports the data sharing requirements of 
The International Committee of Medical Journal Editors (ICMJE) published on the 6th June 2017 
[2]. In accordance, Smith & Nephew will consider requests to share individual (de-identified) 
participant data that underlie the results of any interventional clinical trial, as presented from the 
1st July 2018 within an ICMJE associated journal. Requests made by researchers who provide a 
methodologically sound proposal will be considered. Requests may include data that underlie 
results presented in text, tables, figures and appendices, together with data dictionaries. 
Availability of these data will begin 9 months and end 36 months after article publication. Data 
supplied may only be used by the researcher(s) named in the approved research proposal for 
the purposes of achieving the aims of the analyses specified therein. All proposals should be 
directed to datasharing.gcs@smith-nephew.com. To gain access, data requestors will need to 
sign a data access agreement. 

 
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CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
SOP-059 Clinical Protocols 
 
 REFERENCES 
1. Clopper, CJ & Pearson ES. (1934) The use of confidence or fiducial limits illustrated in the 
case of the binomial. Biometrika, 26, 404 413. 
2. Taichman, DB, et al. Data Sharing Statements for Clinical Trials: A Requirement of the 
International Committee of Medical Journal Editors. Ann Intern Med. 2017. 6th June. 
doi:10.7326/M17-1028 
 
 
 

 
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CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
SOP-059 Clinical Protocols 
 
 APPENDICES 
26.1  PRINCIPAL INVESTIGATOR OBLIGATIONS (ISO14155) 
1. General:  
a. The role of the PI is to implement and manage the day-to-day conduct of the clinical 
investigation as well as ensure data integrity and the rights, safety, and well-being of 
the subjects involved in the clinical investigation.  
2. Qualification of the PI. The PI shall: 
a. be qualified by education, training, and experience to assume responsibility for the 
proper conduct of the clinical investigation in accordance with this International 
Standard; evidence of such qualifications of the PI and key members of the investigation 
site team shall be provided to the Sponsor through up-to-date Curriculum Vitae (CV) or 
other relevant documentation, 
b. be experienced in the field of application and trained in the use of the investigational 
device under consideration, 
c. 
disclose potential conflicts of interest, including financial, that interfere with the conduct 
of the clinical investigation or interpretation of results, and 
d. be knowledgeable with the method of obtaining informed consent. 
3. Qualification of investigation site. The PI shall be able to demonstrate that the proposed 
investigation site: 
a. has the required number of eligible subjects needed within the agreed recruitment 
period, and 

 
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CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
SOP-059 Clinical Protocols 
 
b. has one or more qualified investigators, a qualified investigation site team and adequate 
facilities for the foreseen duration of the clinical investigation. 
4. Communication with the IEC. The PI shall:  
a. provide the Sponsor with copies of any clinical-investigation-related communications 
between the PI and the IEC, 
b. comply with the requirements described in 4.5 of ISO 14155: 
i. 
Submit to the IEC the following information, any amendments and any additional 
documentation required by the IEC: the Protocol; IB or equivalent; informed 
consent form and any other written information provided to subjects; procedures 
for recruiting subjects and advertising materials, if any; a copy of the CV of the 
PI(s) for with the IEC has oversight. 
ii. 
Provide documentation of the IECs approval/favorable opinion, identifying the 
documents and amendments on which the opinion was based, to the Sponsor, 
prior to commencing the clinical investigation.  
iii. 
Submit the following to the IEC if required by national regulations, the protocol or 
IEC, whichever is more stringent: 
1. 
SAEs 
2. Requests for deviations, and reports of deviations, if the deviation affects 
, and well-being, or the scientific integrity of the clinical 
investigation. Document and report to the Sponsor and IEC a report of 
deviations made to protect the rights, safety, and well-being of human 
subjects under emergency circumstances.  
3. Progress reports, including safety summary and deviations 

 
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CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
SOP-059 Clinical Protocols 
 
4. Amendments to any documents already approved by the IEC.  
5. If applicable, notifications of suspension or premature termination 
6. If applicable, justification and request for resuming the clinical investigation 
after suspension.  
7. Clinical investigation report or summary. 
iv. 
As a minimum, during the clinical investigation, the following information shall be 
obtained in writing from the IEC prior to implementation: 
1. 
Approval/favorable opinion of amendments 
2. 
safety, and well-being or scientific integrity of the clinical investigation 
3. Approval for resumption of a suspended clinical investigation if applicable.  
c. 
obtain the written and dated approval/favorable opinion of the IEC for the clinical 
investigation before recruiting subjects and implementing all subsequent amendments, 
if required, 
d. promptly report any deviations from the protocol that affect the rights, safety or well-
being of the subject or the scientific integrity of the clinical investigation, including those 
which occur under emergency circumstances, if required by the IEC, protocol or national 
regulations. In particular circumstances, the communication with the IEC can be 
performed by the Sponsor, partly or in full, in which case the Sponsor shall keep the 
Principal Investigator informed. 
5. Informed consent process. The PI shall: 
a. General: 

 
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CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
SOP-059 Clinical Protocols 
 
i. 
Informed consent shall be obtained in writing from the subject and the process 
shall be documented before any procedure specific to the clinical investigation is 
applied to the subject; except when special circumstances for emergency 
treatments apply (see below) 
ii. 
The informed consent form consists of an information form and informed consent 
signature form. These two forms can either be combined in one document or 
separated into two documents 
b. Process of obtaining informed consent. The general process for obtaining informed 
consent shall be documented in the protocol and shall comply with the following. These 
legally authorized representative:  
i. 
Ensure that the PI or his/her authorized designee conducts the informed consent 
process 
ii. 
decision to participate throughout the clinical investigation 
iii. 
Avoid any coercion or undue improper influence on, or inducement of, the subject 
to participate 
iv. 
 
v. 
Use native non-technical language that is understandable to the subject 
vi. 
Provide ample time for the subject to read and understand the informed consent 
form and to consider participation in the clinical investigation 
vii. 
Include personally dated signatures and the PI or an authorized designee 
responsible for conducting the informed consent process 

 
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CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
SOP-059 Clinical Protocols 
 
viii. 
Show how informed consent will be obtained in special circumstances (see below) 
where the subject is unable to provide him or herself, and  
ix. 
Ensure important new information is provided to new and existing subjects 
throughout the clinical investigation.  
c. 
Special circumstances for informed consent (the following provisions are subject to 
national regulations): 
i. 
Subject needing legally authorized representatives: the legally authorized 
representative may give informed consent only if a subject is unable to make the 
decision to participate in a clinical investigation (e.g. infant, child, or juvenile, 
seriously ill or unconscious subject, mentally ill person, mentally handicapped 
person). In such cases, the subject shall also be informed about the clinical 
investigation within his/her ability to understand.  
ii. 
Subject unable to read or write: informed consent shall be obtained through a 
supervised oral process if a subject or legally authorized representative is unable 
to read or write. An independent witness shall be present throughout the process. 
The written informed consent form and any other information shall be read aloud 
and explained to the prospective subject or his/her legally authorized 
representative and, whenever possible, either shall sign and personally date the 
informed consent form. The witness also signs and personally dates the informed 
consent for attesting that the information was accurately explained and that the 
informed consent was freely given.  
iii. 
Emergency treatments:  

 
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CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
SOP-059 Clinical Protocols 
 
1. 
For clinical investigations involving emergency treatments, when prior 
representative, if present, shall be requested.  
2. When it is not possible to obtain prior informed consent from the subject, and 
may still be enrolled if a specific process has been described in the protocol.  
3. Arrangements shall be made to inform the subject or legally authorized 
representative
clinical investigation and about all aspects of the clinical investigation.  
4. The subject shall be asked to provide informed consent for continued 
participation as soon as his/her medical condition allows.  
d. The Principal Investigator may not enroll a subject without obtaining informed consent of 
the subject or his/her legally authorized representative only when the following 
conditions are fulfilled: the prospective subject fulfils the emergency conditions and is 
obviously in a life-threatening situation; no sufficient clinical benefits are anticipated 
from the currently available treatment; there is a fair possibility that the life-threatening 
risk to the prospective subject can be avoided if the investigational device is used; 
anticipated risks are outweighed by the potential benefits of applying the investigational 
device ; the legally authorized representative cannot be promptly reached and informed.  
e. Information provided to the subject. All information pertinent to the clinical investigation, 
including at least the following, shall be provided in writing and in native, non-technical 

 
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CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
SOP-059 Clinical Protocols 
 
authorized 
representative): 
i. 
Description and purpose 
ii. 
Potential benefits 
iii. 
Risks and inconveniences or the subject and, when applicable, for any embryo, 
foetus or nursing infant 
iv. 
Alternative procedures 
v. 
Confidentiality 
vi. 
Compensation 
vii. 
Anticipated expenses, if any, to be borne by the subject for participating in the 
clinical investigation 
viii. 
Information on the role of Sponsor
 
ix. 
Contact persons 
x. 
Statement declaring that new findings or the reasons for any amendment to the 
protocol that affe
the subject.  
xi. 
 
xii. 
Termination procedures 
f. 
Informed consent signature shall contain the following:  
i. 
The voluntary agreement to participate in the clinical investigation and follow the 
 
ii. 
A statement declaring that refusal of participation incurs no penalty for the subject 

 
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CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
SOP-059 Clinical Protocols 
 
iii. 
A statement declaring that discontinuation at any time incurs no penalty for the 
subject 
iv. 
A statement with regard to the possible consequences of withdrawal 
v. 
An acknowledgement of the information provided and confirmation that all the 
s questions were answered 
vi. 
A statement confirming that the subject or his/her legally authorized 
purpose of the clinical investigation 
vii. 
A statement confirming that the subject or his/her legally authorized 
representative agrees that Sponsor
IEC 
 
g. New information: if new information becomes available that can significantly affect a 
subject(s) affected in written form. If relevant, all affected subjects shall be asked to 
confirm their continuing consent in writing.  
h. ensure compliance with the applicable regulatory requirements and ethical principles for 
the process of obtaining informed consent, and 
i. 
ensure and document appropriate training if an authorized designee is appointed to 
conduct the informed consent process. 
6. Compliance with the protocol. The Principal Investigator shall: 
a. indicate his/her acceptance of the protocol in writing, 
b. conduct the clinical investigation in compliance with the protocol, 

 
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CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
SOP-059 Clinical Protocols 
 
c. 
create and maintain source documents throughout the clinical investigation and make 
them available as requested during monitoring visits or audits, 
d. ensure that the investigational device is used solely by authorized users as specified in 
6.2, and in accordance with the protocol and instructions for use, 
e. propose to the Sponsor any appropriate modification(s) of the protocol or investigational 
device or of the use of the investigational device, 
f. 
refrain from implementing any modifications to the protocol without agreement from the 
Sponsor, IEC and regulatory authorities, if required, 
g. document and explain any deviation from the approved protocol that occurred during 
the course of the clinical investigation, 
h. ensure that an adequate investigation site team and facilities exist and are maintained 
and documented during the clinical investigation, 
i. 
ensure that maintenance and calibration of the equipment relevant for the assessment 
of the clinical investigation is appropriately performed and documented, where 
applicable, 
j. 
ensure the accuracy, completeness, legibility and timeliness of the data reported to the 
Sponsor in the CRF and in all required reports, 
k. maintain the device accountability records, 
l. 
allow and support the Sponsor to perform monitoring and auditing activities, 
m. be accessible to the monitor and respond to questions during monitoring visits, 
n. allow and support regulatory authorities and the IEC when performing auditing activities, 
o. ensure that all clinical-investigation-related records are retained as required taking 
measures to prevent accidental or premature destruction, and 

 
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CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
SOP-059 Clinical Protocols 
 
p. review and sign the clinical investigation report, as applicable. 
7. Medical care of subjects. The Principal Investigator shall 
a. provide adequate medical care to a subject during and after a subject's participation in 
a clinical investigation in the case of adverse events,  
b. inform the subject of the nature and possible cause of any adverse events experienced, 
c. 
provide the subject with the necessary instructions on proper use, handling, storage, 
and return of the investigational device, when it is used or operated by the subject, 
d. inform the subject of any new significant findings occurring during the clinical 
investigation, including the need for additional medical care that may be required, 
e. provide the subject with well-defined procedures for possible emergency situations 
related to the clinical investigation, and make the necessary arrangements for 
emergency treatment, including decoding procedures for blinded/masked clinical 
investigations, as needed, 
f. 
ensure that clinical records are clearly marked to indicate that the subject is enrolled in 
a particular clinical investigation, 
g. if appropriate, subjects enrolled in the clinical investigation shall be provided with some 
means of showing their participation in the clinical investigation, together with 
identification and compliance information for concomitant treatment measures (contact 
address and telephone numbers shall be provided), 
h. inform, with the subject's approval or when required by national regulations, the 
subject's personal physician about the subject's participation in the clinical 
investigation, and  

 
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CONFIDENTIAL AND PROPRIETARY 
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intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
SOP-059 Clinical Protocols 
 
i. 
make all reasonable efforts to ascertain the reason(s) for a subject's premature 
withdrawal from the clinical investigation while fully respecting the subject's rights. 
8. Safety reporting. The Principal Investigator shall: 
a. record every adverse event and observed device deficiency, together with an 
assessment, 
b. report to the Sponsor, without unjustified delay, all serious adverse events and device 
deficiencies that could have led to a serious adverse device effect; this information shall 
be promptly followed by detailed written reports, as specified in the protocol, 
c. 
c) report to the IEC serious adverse events and device deficiencies that could have led 
to a serious adverse device effect, if required by the national regulations or protocol or 
by the IEC, 
d. report to regulatory authorities serious adverse events and device deficiencies that 
could have led to a serious adverse device effect, as required by the national 
regulations, and 
e. supply the Sponsor, upon Sponsor's request, with any additional information related to 
the safety reporting of a particular event.