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Zimmer ActivBraid for Rotator Cuff Repair

This observational study is looking at how well a new type of suture, ActivBraid™Collagen Co-Braid, helps with rotator cuff repair (RCR) in the shoulder. This suture is made from a mix of strong plastic and collagen, a natural protein found in our bodies. Researchers will follow up to 65 patients who have surgery for a tear in their supraspinatus and/or infraspinatus tendons. They will check how well the repair heals and also measure shoulder movement, strength, and how patients feel about their shoulder at 6 months, 1 year, and 2 years after surgery. To join, you must be between 18 and 75 years old and have a specific type of rotator cuff tear. The study is currently unclear about its recruitment status.

Study design
This is an observational study involving up to 65 participants. The study does not specify a phase.
What's involved
Participants will have their rotator cuff repaired using ActivBraid™Collagen Co-Braid suture. Their shoulder healing, range of motion, strength, and patient-reported outcomes will be evaluated at 6 months, 1 year, and 2 years after surgery.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 2 years after their surgery to assess healing and other outcomes.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06971497

Zimmer ActivBraid Rotator Cuff Repair (RCR) Study

Recruiting
Not specifiedAges 18–75Observational
The Cleveland Clinic
~65 participants
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:ActivBraid™Collagen Co-Braid suture (Zimmer Biomet)

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Rotator cuff repair healing
Measured over 1 year post-operation
+1 more outcome measured

Conditions

Rotator Cuff Repair of the Shoulder

Explore related trials

Rupture of rotator cuff of shoulder

NCT06971497

Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Cleveland Clinic

    Cleveland, Ohiostudy coordinator listed

    Recruiting

  • Cleveland Clinic

    Cleveland, Ohiostudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Kathleen Derwin, PhD · PRINCIPAL_INVESTIGATOR · The Cleveland Clinic
  • Eric Ricchetti, MD · PRINCIPAL_INVESTIGATOR · The Cleveland Clinic

Who to contact

Kathleen Derwin, PhD
[email protected]
216-408-7930
Email the study team

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Eligibility criteria

Inclusion

18-75 years
acute or chronic, reparable, 1-5 cm full thickness tear of the supraspinatus and/or infraspinatus tendons

Exclusion

prior ipsilateral shoulder surgery
outstanding worker's compensation claim
symptomatic cervical spine disease
a frozen shoulder
advanced glenohumeral arthritis
isolated subscapularis tear
significant radiation exposure for other medical reasons.
known is advance to be claustrophobic
known history of hypersensitivity to bovine-derived materials.

What this trial measures

  • Rotator cuff repair healing1 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 healing1 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.