Zimmer ActivBraid Rotator Cuff Repair (RCR) Study

• 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™.

Primary outcomes

• Rotator cuff repair healing [1 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 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 outcomes

• 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).

Sex: All, ages: 18 Years to 75 Years

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.

• Kathleen Derwin, PhD, Principal investigator, The Cleveland Clinic
• Eric Ricchetti, MD, Principal investigator, The Cleveland Clinic