RECRUITING

Zimmer ActivBraid Rotator Cuff Repair (RCR) Study

Description

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 Overview

Study Details

Study overview

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.

Cleveland Clinic ActivBraid Rotator Cuff Repair (RCR) Study

Zimmer ActivBraid Rotator Cuff Repair (RCR) Study

Condition
Rotator Cuff Repair of the Shoulder
Intervention / Treatment

-

Contacts and Locations

Cleveland

Cleveland Clinic, Cleveland, Ohio, United States, 44195

Cleveland

Cleveland Clinic, Cleveland, Ohio, United States, 44195

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

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

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

The Cleveland Clinic,

Kathleen Derwin, PhD, PRINCIPAL_INVESTIGATOR, The Cleveland Clinic

Eric Ricchetti, MD, PRINCIPAL_INVESTIGATOR, The Cleveland Clinic

Study Record Dates

2029-08