Quattro® X Suture Anchor With BroadBand™ Tape Post Market Clinical Follow-up Study (Incl. Instruments)
Conditions: Rotator Cuff Tears, Rotator Cuff Injuries
Sponsor: Zimmer Biomet

 
 
Quattro X with Broadband Study 
Protocol number: CME2021-24SM 
1 
 
 
 
 
 
 
 
Quattro® X Suture Anchor with BroadBand™ 
Tape Post Market Clinical Follow-up Study 
(incl. Instruments) - 
Retrospective and prospective, consecutive, multicenter, 
non-randomized, non-controlled study 
 
Protocol number: CME2021-24SM 
Protocol date: 27 April 2022 
NCT number: NCT05690776 
 
 
 

 
 
Quattro X with Broadband Study 
Protocol number: CME2021-24SM 
2 
1 
STUDY SYNOPSIS 
 
<copy this information from last approved protocol> 
 
Complete Protocol Title 
Quattro® X Suture Anchor with BroadBand™ Tape 
Post Market Clinical Follow-up Study (incl. Instruments) 
Protocol Number 
CME2021-24SM 
Short Protocol Title 
Quattro® X with BroadBand 
Sponsor 
Zimmer Biomet, Warsaw, Indiana, United States 
Manufacturer 
Cayenne Medical Inc. 
Study Device(s) 
Quattro X Suture Anchors with BroadBand Tape 
- 5.5mm Quattro X Suture Anchor Double-Loaded with 
BroadBand Tape (Non-Sliding) 
- 6.5mm Quattro X Suture Anchor Double-Loaded with 
BroadBand Tape (Non-Sliding) 
- 5.5mm Quattro X Suture Anchor Double-Loaded with 
BroadBand Tape (Sliding) 
- 6.5mm Quattro X Suture Anchor Double-Loaded with 
BroadBand Tape (Sliding) 
 
Quattro X Suture Anchor Reusable Instruments (Non-
Sterile) 
- Awl, 5.5/6.5mm Quattro X Suture Anchor 
- Tap, 5.5mm Quattro X Suture Anchor 
- Tap, 6.5mm Quattro X Suture Anchor 
Study Objectives/Endpoints 
The objective of the study is to collect data confirming 
safety, performance and clinical benefits of the Quattro® X 
Suture Anchor with BroadBand™ Tape and Instruments 
when used in rotator cuff repair. 
 
The primary endpoint of this study is the assessment of 
performance by analyzing soft tissue to bone healing in the 
shoulder (rotator cuff). Healing will be assessed by the 
investigator using PROMs and clinical outcomes of the 
patient. 
The clinical benefit will be assessed by functional 
outcomes measured using standard and well-established 
scoring systems (e.g. Constant & Murley and EQ-5D-5L) at 
1 year post-operative. 
The safety will be assessed by monitoring the incidence 
and frequency of device- and/or procedure-related 
adverse events. 

 
 
Quattro X with Broadband Study 
Protocol number: CME2021-24SM 
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Indications/Target Population 
Subjects treated with the Quattro® X Suture Anchor with 
BroadBand™ Tape for rotator cuff repair, according to the 
IFU and who meet all of the inclusion and none of 
exclusion criteria. 
Inclusion/Exclusion Criteria 
The indications/contra-indications are in line with the 
Instruction for Use (IFU). 
 
Inclusion Criteria: 
Quattro® X Suture Anchors are intended for use for the 
reattachment of soft tissue to bone for Rotator Cuff 
Repairs. 
1. Subject treated with the Quattro® X Suture Anchor with 
BroadBand™ Tape for rotator cuff repair; 
2. Older than 18 years and skeletally mature; 
3. Willing and able to comply with the study procedures; 
4. Subject is capable of understanding the doctor’s 
explanations, following his instructions and is able to 
participate in the follow-up program; 
5. Subject is able to read and understand the ICF and has 
voluntarily provided written informed consent. 
 
Exclusion Criteria: 
1. Presence of infection; 
2. Insufficient or immature bone; 
3. Insufficient blood supply or previous infections which 
may hinder the healing process; 
4. Foreign body sensitivity; 
5. Subject is vulnerable (prisoner, mentally incompetent or 
unable to understand what participation to the study 
entails, a known alcohol or drug abuser, anticipated to be 
non-compliant); 
6. The subject is unwilling or unable to give consent or to 
comply with the follow-up program; 
7. Subject meets any contraindications of the appropriate 
Instruction for Use. 
Study Design 
Retrospective and prospective, consecutive, multicenter, 
non-randomized, non-controlled study 
Clinical Phase 
Post-market 
Sample Size  
Maximum of 109 study subjects implanted with the study 
device.   
Length of Study 
1 year 

 
 
Quattro X with Broadband Study 
Protocol number: CME2021-24SM 
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Materials and Methods 
Retrospective inclusion of 109 subjects who are eligible for 
rotator cuff repair with the Quattro® X Suture Anchors 
with BroadBand™ Tape. Prospective follow-up visit at 1 
year postoperative. 
Data Collection 
Paper/Electronic 
Statistical Reporting 
Data collected will be summarized and reported to each 
participating investigator.  Statistical analysis will be 
conducted by Zimmer Biomet or its designee. Survivorship 
will be evaluated using Kaplan-Meier. 
Scores/Performance Assessments 
 
Standards 
The PMCF is compliant with the below: 
• 
ISO 14155: 2020 - Clinical investigation of medical de-
vices for human subjects - Good clinical practice. 
• 
The Declaration of Helsinki (DoH) - Ethical principles 
for medical research involving human subjects. 
• 
European Regulation (EU) 2017/745 
Study Funding 
Funding for this clinical study is made available by Zimmer 
Biomet to support clinical data collection, other expenses 
associated with the conduct and execution of this study 
protocol as outlined in the fully executed Clinical Trial 
Agreement. 
 
 
 

 
 
Quattro X with Broadband Study 
Protocol number: CME2021-24SM 
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2 
STATISTICAL ANALYSIS PLAN 
2.1 Sample Size 
The overall success rate will be calculated based on the percentage of subjects who have successful 
healing. The following hypothesis will be tested by the exact binomial test 
H0: E1 – E0 ≤ - δE 
Ha: E1 – E0 > - δE 
Where: 
E0 = 85%, the expected success rate of similar devices 
E1 = the success rate in the Quattro® X Suture Anchor with BroadBand™ Tape treatment group 
δE = 0.10, non-inferiority margin for healing 
In addition, one-sided 95% exact confidence Interval (CI), lower limit of the success rate, will be 
calculated. 
Based on the hypothesis test above, 103 subjects will provide approximately 80% power for the one-
sided exact binomial test at 0.05 significant level. The sample size was calculated using SAS for 
Windows version 9.4. To account for an expected 5% loss-to-follow up, 109 patients will be enrolled. 
 
2.2 General Statistical Methods 
Continuous data, such as age, will be summarized by using means, medians, standard deviation, 
minimum, maximum, and 95% CI over the time periods of interest. Categorical data, such as gender 
or surgical approach, will be summarized by counts and percentages. Implant survival will be 
summarized using a Kaplan-Meier method and presented with rates (as percentages) and confidence 
intervals (CI). Statistical analyses will be performed using SAS 9.4. The binomial distribution tests will 
have 80% probability of computing a one-sided 95% lower confidence bound on survivorship of each 
device with a non-inferiority margin of 0.09. Patient confidentiality will be protected at all times, and 
patient identifiers will not be included in data summaries. 
Handling of Missing and Incomplete Data: Data will be considered “censored” for the primary 
endpoint if the survivorship outcome cannot be determined or is unavailable for a subject. Every 
effort will be made to collect the data necessary to evaluate the primary endpoint. Patients who 
have been lost to follow-up will not be included in the primary study analysis at the end of 1 year. 
However, the data already collected will be used in interim analysis and survivorship calculations. 
Sensitivity analyses will be performed to assess the impact of missing data on the primary study 
analysis. These analyses may include a best-case and worst-case imputation as well as a tipping point 
analysis. 
 
2.3 Data Analysis 
The Per Protocol population will be defined as those subjects that undergo a successful implantation 
of the Quattro® X Suture Anchor with BroadBand™ Tape. Analyses on the primary and secondary 
endpoints will use this population as well as any exploratory analyses. 

 
 
Quattro X with Broadband Study 
Protocol number: CME2021-24SM 
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The primary endpoint will be determined at the only clinical assessment, about one year from the 
index surgery. The absence of a revision surgery or re-tear not previously noted on the case report 
form will denote a success (within 425 days from index surgery). All other cases will be a failure and 
have a documented revision surgery or re-tear. 
Secondary analyses will include a summary of any clinical scores captured at baseline and the one 
year assessment; change from baseline analyses may be developed. In addition, a summary of 
medications and patient satisfaction may also be assessed. 
Any potential exploratory analysis that assess outcomes be categories (gender, age, etc.) will use 
appropriate statistical test for the type of variable (i.e. t-tests, ANOVA, Fisher’s Exact, etc). All testing 
will use a Type I error of 0.05 and no p-values will be adjusted for multiplicity. 
Adverse events will also be captured at the one year assessment. Only AEs that occur on or after the 
index surgery and before any potential revisions or re-tears will be summarized. Adverse events will 
be presented as the number of cases for each AE and the number of times the give AE occurred. 
Finally, a complete listing of all AEs will be presented.