Zimmer ActivBraid Rotator Cuff Repair (RCR) Study

The Cleveland Clinic65 enrolled

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Rotator Cuff Repair of the Shoulder

Interventions

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™.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (2)

Cleveland Clinic

Cleveland, Ohio, United States

RECRUITING

Cleveland Clinic

Cleveland, Ohio, United States

RECRUITING

Outcomes

Primary Outcomes

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.