Zimmer ActivBraid Rotator Cuff Repair (RCR) Study

Not yet recruiting

• Conditions: Rotator Cuff Repair of the Shoulder

• Registration Number: NCT06971497
• Lead Sponsor: The Cleveland Clinic

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-29
• Study First Submitted QC: 2025-05-06
• Last Update Submitted: 2025-05-06
• Study Start: 2025-05-12
• Study First Posted: 2025-05-14
• Last Update Posted: 2025-05-14
• Primary Completion: 2029-07-01
• Study Completion: 2029-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

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

Exclusion Criteria

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rotator cuff repair healing	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.

Secondary Outcome Measures

Name	Time	Method
Patient-reported outcome measures	1 year post-operation	Patients will be asked to answer the American Shoulder and Elbow Surgeons (ASES) Score from 0-100 points where higher score indicates better outcome.
Shoulder strength	1 year post-operation	Isometric shoulder strength in pounds will be assessed using a table mounted dynamometer.
Shoulder range of motion	1 year post-operation	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).

Trial Locations

Locations (1)

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States