Rotator Cuff Repair of the ShoulderNCT06971497
Zimmer ActivBraid Rotator Cuff Repair (RCR) Study
An observational study of Rotator Cuff Repair of the Shoulder, run by The Cleveland Clinic at 2 sites in United States.
Trial summary
We will enroll up to 65 patients undergoing primary arthroscopic rotator cuff repair (RCR) using ActivBraid™Collagen Co-Braid suture (Zimmer Biomet) and evaluate RCR healing as well as shoulder range of motion, strength, and patient-reported outcomes at 6m, 1y and 2y. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rotator Cuff Repair of the Shoulder
- What is being tested?
- ActivBraid™Collagen Co-Braid suture (Zimmer Biomet)
- Type of treatment
- Medical device
- How many people
- 65 participants
- Where
- 2 sitesUnited States
- Study dates
- 11 Aug 2025to Aug 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing primary arthroscopic rotator cuff repair
Who may be able to join
- 18-75 years
- acute or chronic, reparable, 1-5 cm full thickness tear of the supraspinatus and/or infraspinatus tendons
Who cannot join
- prior ipsilateral shoulder surgery
- outstanding worker's compensation claim
- symptomatic cervical spine disease
- a frozen shoulder
- advanced glenohumeral arthritis
- isolated subscapularis tear
Show all 9Show fewer
- significant radiation exposure for other medical reasons.
- known is advance to be claustrophobic
- known history of hypersensitivity to bovine-derived materials.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
Kathleen Derwin, PhD, 216-408-7930, derwink@ccf.org
Cathy Shemo, BS, 216-218-1722, shemoc@@ccf.org
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
Kathleen Derwin, PhD, 216-408-7930, derwink@ccf.org
Cathy Shemo, BS, 216-218-1722, shemoc@@ccf.org
About this study
Official title: Cleveland Clinic ActivBraid Rotator Cuff Repair (RCR) Study
We will enroll up to 65 patients undergoing primary arthroscopic rotator cuff repair (RCR) using ActivBraid™Collagen Co-Braid suture (Zimmer Biomet) and evaluate RCR healing as well as shoulder range of motion, strength, and patient-reported outcomes at 6m, 1y and 2y.
- Conditions
- Rotator Cuff Repair of the Shoulder
- Being tested
- ActivBraid™Collagen Co-Braid suture (Zimmer Biomet)
- Keywords
- rotator cuff repair, shoulder, rotator cuff tear, collagen suture
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ActivBraid™Collagen Co-Braid suture (Zimmer Biomet)Device
ActivBraid™ is a suture made from approximately half ultra-high molecular weight polyethylene and and half collagen derived from cow skin. Collagen is the most abundant protein in our bodies and serves as the building block for tendons and bones. The collagen in ActivBraid™ is intended to enhance cell attachment and tissue integration which may improve the healing of a rotator cuff repair. ActivBraid™ suture has been shown to have equivalent strength as other high strength sutures used in orthopaedic procedures and has been approved by the Food and Drug Administration (FDA) for repairing tendons. ActivBraid™ is a commercially available product that has been and is used in humans. This is the first post-market clinical study with ActivBraid™.
| Study group | Role | What they receive |
|---|---|---|
| patients undergoing primary arthroscopic rotator cuff repair | Patients undergoing primary arthroscopic rotator cuff repair will have their repair completed with ActivBraid™Collagen Co-Braid suture (Zimmer Biomet). Receives: Device: ActivBraid™Collagen Co-Braid suture (Zimmer Biomet) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rotator cuff repair healing
Patients will undergo magnetic resonance imaging (MRI) of the shoulder from which healing of their rotator cuff repair will be classified using Sugaya score from 1-5, where higher score indicated worse healing.
Measured: 1 year post-operation
Rotator cuff repair healing
Patients will also undergo computed tomography (CT) scans of the shoulder from which tendon retraction of the rotator cuff repair will also be measured in millimeters where higher tendon retraction indicates worse healing.
Measured: 1 year post-operation
Secondary outcomes (3)
Patient-reported outcome measures
Patients will be asked to answer the American Shoulder and Elbow Surgeons (ASES) Score from 0-100 points where higher score indicates better outcome.
Measured: 1 year post-operation
Shoulder strength
Isometric shoulder strength in pounds will be assessed using a table mounted dynamometer.
Measured: 1 year post-operation
Shoulder range of motion
Shoulder range-of-motion will be assessed by asking patients to lift their affected arm overhead in the scapular plane and measuring the range with a manual goniometer (degrees).
Measured: 1 year post-operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2025
- Study start11 Aug 2025
- Primary completionAug 2029 (estimated)
- Study completionAug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff Repair of the ShoulderStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Zimmer Biomet
- Responsible party
- Principal investigator, Kathleen Derwin, PhD, The Cleveland Clinic
- Investigators
- Kathleen Derwin, PhD, Principal investigator, The Cleveland ClinicEric Ricchetti, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06971497
- Sponsor's protocol ID
- 25-252
- Status last verified
- Aug 2026
- First submitted
- 29 Apr 2025
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cleveland Clinic ActivBraid Rotator Cuff Repair (RCR) Study
- ClinicalTrials.gov ID
- NCT06971497
- Acronym / sponsor ID
- 25-252
- Conditions
- Rotator Cuff Repair of the Shoulder
- Keywords
- rotator cuff repair, shoulder, rotator cuff tear, collagen suture
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- Zimmer Biomet
- Study start
- 11 Aug 2025 (actual)
- Primary completion
- Aug 2029 (estimated)
- Study completion
- Aug 2029 (estimated)
- First posted
- 14 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We will enroll up to 65 patients undergoing primary arthroscopic rotator cuff repair (RCR) using ActivBraid™Collagen Co-Braid suture (Zimmer Biomet) and evaluate RCR healing as well as shoulder range of motion, strength, and patient-reported outcomes at 6m, 1y and 2y.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients undergoing primary arthroscopic rotator cuff repair | – | Device: ActivBraid™Collagen Co-Braid suture (Zimmer Biomet)Patients undergoing primary arthroscopic rotator cuff repair will have their repair completed with ActivBraid™Collagen Co-Braid suture (Zimmer Biomet). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing primary arthroscopic rotator cuff repair
Key inclusion criteria (2 listed)
- 18-75 years
- acute or chronic, reparable, 1-5 cm full thickness tear of the supraspinatus and/or infraspinatus tendons
Key exclusion criteria (9 listed)
- prior ipsilateral shoulder surgery
- outstanding worker's compensation claim
- symptomatic cervical spine disease
- a frozen shoulder
- advanced glenohumeral arthritis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ActivBraid™Collagen Co-Braid suture (Zimmer Biomet)ActivBraid™ is a suture made from approximately half ultra-high molecular weight polyethylene and and half collagen derived from cow skin. Collagen is the most abundant protein in our bodies and serves as the building block for tendons and bones. The collagen in ActivBraid™ is intended to enhance cell attachment and tissue integration which may improve the healing of a rotator cuff repair. ActivBraid™ suture has been shown to have equivalent strength as other high strength sutures used in orthopaedic procedures and has been approved by the Food and Drug Administration (FDA) for repairing tendons. ActivBraid™ is a commercially available product that has been and is used in humans. This is the first post-market clinical study with ActivBraid™. | Device | patients undergoing primary arthroscopic rotator cuff repair |
Primary outcome
Rotator cuff repair healing
Time frame: 1 year post-operation
Patients will undergo magnetic resonance imaging (MRI) of the shoulder from which healing of their rotator cuff repair will be classified using Sugaya score from 1-5, where higher score indicated worse healing.
Rotator cuff repair healing
Time frame: 1 year post-operation
Patients will also undergo computed tomography (CT) scans of the shoulder from which tendon retraction of the rotator cuff repair will also be measured in millimeters where higher tendon retraction indicates worse healing.
3 secondary outcomes
Patient-reported outcome measures
Time frame: 1 year post-operation
Shoulder strength
Time frame: 1 year post-operation
Shoulder range of motion
Time frame: 1 year post-operation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- product information for ActivBraid™Collagen Co-Braid suture (Zimmer Biomet)Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kathleen Derwin, PhD principal investigator
The Cleveland Clinic
Eric Ricchetti, MD principal investigator
The Cleveland Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rotator Cuff Repair of the Shoulder, run by The Cleveland Clinic at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kathleen Derwin, PhD (216-408-7930, derwink@ccf.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rotator cuff repair healing (time frame: 1 year post-operation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.