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| Name | Class |
|---|---|
| Zimmer Biomet | INDUSTRY |
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We will enroll up to 65 patients undergoing primary arthroscopic rotator cuff repair (RCR) using ActivBraidâ„¢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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patients undergoing primary arthroscopic rotator cuff repair | Patients undergoing primary arthroscopic rotator cuff repair will have their repair completed with ActivBraidâ„¢Collagen Co-Braid suture (Zimmer Biomet). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ActivBraidâ„¢Collagen Co-Braid suture (Zimmer Biomet) | Device | ActivBraidâ„¢ 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 ActivBraidâ„¢ is intended to enhance cell attachment and tissue integration which may improve the healing of a rotator cuff repair. ActivBraidâ„¢ 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. ActivBraidâ„¢ is a commercially available product that has been and is used in humans. This is the first post-market clinical study with ActivBraidâ„¢. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 year post-operation |
| Rotator cuff repair healing | 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. | 1 year post-operation |
| Measure | Description | Time Frame |
|---|---|---|
| Patient-reported outcome measures | Patients will be asked to answer the American Shoulder and Elbow Surgeons (ASES) Score from 0-100 points where higher score indicates better outcome. | 1 year post-operation |
| Shoulder strength |
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Inclusion Criteria:
Exclusion Criteria:
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Patients undergoing primary arthroscopic rotator cuff repair
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kathleen Derwin, PhD | Contact | 216-408-7930 | derwink@ccf.org | |
| Cathy Shemo, BS | Contact | 216-218-1722 | shemoc@ccf.org |
| Name | Affiliation | Role |
|---|---|---|
| Kathleen Derwin, PhD | The Cleveland Clinic | Principal Investigator |
| Eric Ricchetti, MD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic | Recruiting | Cleveland | Ohio | 44195 | United States |
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| Label | URL |
|---|---|
| product information for ActivBraidâ„¢Collagen Co-Braid suture (Zimmer Biomet) | View source |
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| ID | Term |
|---|---|
| D000070636 | Rotator Cuff Injuries |
| ID | Term |
|---|---|
| D012421 | Rupture |
| D014947 | Wounds and Injuries |
| D000070599 | Shoulder Injuries |
| D013708 | Tendon Injuries |
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Isometric shoulder strength in pounds will be assessed using a table mounted dynamometer.
| 1 year post-operation |
| Shoulder range of motion | 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). | 1 year post-operation |
| Cleveland Clinic | Recruiting | Cleveland | Ohio | 44195 | United States |
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