Rotator Cuff Repair of the Shoulder
Conditions
Keywords
rotator cuff repair, shoulder, rotator cuff tear, collagen suture
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.
Interventions
DEVICEActivBraid™Collagen Co-Braid suture (Zimmer Biomet)
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™.
Sponsors
The Cleveland Clinic
Zimmer Biomet
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| Shoulder strength | 1 year post-operation | Isometric shoulder strength in pounds will be assessed using a table mounted dynamometer. |
| 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. |
Countries
United States
Contacts
CONTACTKathleen Derwin, PhD
CONTACTCathy Shemo, BS
PRINCIPAL_INVESTIGATORKathleen Derwin, PhD
The Cleveland Clinic
PRINCIPAL_INVESTIGATOREric Ricchetti, MD
The Cleveland Clinic
Outcome results
None listed