Actively Recruiting

Age: 18Years - 75Years
All Genders
NCT06971497

Zimmer ActivBraid Rotator Cuff Repair (RCR) Study

Led by The Cleveland Clinic · Updated on 2025-08-17

65

Participants Needed

2

Research Sites

207 weeks

Total Duration

On this page

Sponsors

T

The Cleveland Clinic

Lead Sponsor

Z

Zimmer Biomet

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Zimmer ActivBraid Rotator Cuff Repair (RCR) Study

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 to 75 years
  • Acute or chronic, reparable, full thickness tear of the supraspinatus and/or infraspinatus tendons measuring 1 to 5 cm
Not Eligible

You will not qualify if you...

  • Prior surgery on the same shoulder (ipsilateral)
  • Current worker's compensation claim
  • Symptomatic cervical spine disease
  • Frozen shoulder
  • Advanced glenohumeral arthritis
  • Isolated subscapularis tendon tear
  • Significant radiation exposure for other medical reasons
  • Known claustrophobia
  • Known allergy or hypersensitivity to bovine-derived materials

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Cleveland Clinic

Cleveland, Ohio, United States, 44195

Actively Recruiting

2

Cleveland Clinic

Cleveland, Ohio, United States, 44195

Actively Recruiting

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Research Team

K

Kathleen Derwin, PhD

CONTACT

C

Cathy Shemo, BS

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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