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The purpose of this clinical registry is to prospectively collect and compare preoperative and postoperative patient-reported data using validated shoulder-specific and health-related quality of life (QoL) instruments during real-world use of the Rotation Medical bioinductive implant to treat rotator cuff tears.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Partial or full-thickness rotator cuff tear | Rotation Medical bioinductive implant |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bioinductive implant | Device |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Shoulder pain | Change between baseline and post-operative shoulder pain over time using a Visual Analog Scale (VAS). | 1 year |
| American Shoulder and Elbow Surgeons Standardized Form for the Assessment of the Shoulder (ASES) | Change between baseline and post-operative ASES shoulder score over time. | 1 year |
| Single Assessment Numeric Evaluation (SANE) Score | Change between baseline and post-operative SANE score over time. | 1 year |
| Veterans RAND 12 Item Health Survey (VR-12) | Change between baseline and post-operative VR-12 score over time. | 1 year |
| Western Ontario Rotator Cuff Index (WORC) | Change between baseline and post-operative WORC score over time. | 1 Year |
| Measure | Description | Time Frame |
|---|---|---|
| Safety assessed by number of Adverse Events and Serious Adverse Events. | Safety will be evaluated by reporting any Adverse Events that occur over the duration of the study and calculating the overall occurrence rate of Adverse Events and Serious Adverse Events | 1 Year |
| Recovery by cumulative number of days shoulder is in a sling |
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Inclusion Criteria:
Exclusion Criteria:
1. Hypersensitive to bovine-derived materials.
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This clinical registry will be a prospective, multi-center registry conducted under a common protocol where all subjects will undergo treatment with the Rotation Medical bioinductive implant.
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| Name | Affiliation | Role |
|---|---|---|
| Louis McIntyre, MD | Phelps Medical Associates | Principal Investigator |
| Rachael Winter | Smith & Nephew, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orthopaedic Specialty Institute | Orange | California | 92868 | United States | ||
| Glenwood Orthopaedic Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31350082 | Derived | McIntyre LF, Bishai SK, Brown PB 3rd, Bushnell BD, Trenhaile SW. Patient-Reported Outcomes After Use of a Bioabsorbable Collagen Implant to Treat Partial and Full-Thickness Rotator Cuff Tears. Arthroscopy. 2019 Aug;35(8):2262-2271. doi: 10.1016/j.arthro.2019.02.019. Epub 2019 Jul 23. |
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| 1 Year |
| Recovery by cumulative time in days between discharge and return to work. | 1 Year |
| Recovery by cumulative time between discharge and return to driving | 1 Year |
| Recovery by cumulative time days between discharge and return to overhead-throwing and non-overhead throwing sports | Overhead-throwing sports overhead-throwing (e.g., baseball, football or exercise where arm extends above head) and non-overhead-throwing (e.g., running, bowling or exercise where arm DOES NOT extend above head) sports. | 1 Year |
| Recovery by cumulative number physical therapy (PT) visits to rehabilitate the index shoulder. | 1 Year |
| Recovery by cumulative number of days of narcotic medication use to manage post-operative shoulder pain. | 1 Year |
| Recovery by cumulative number corticosteroid injections used to manage post-operative shoulder pain. | 1 Year |
| Revision Surgery | Number of participants with a revision surgery. | 1 Year |
| Glenwood Springs |
| Colorado |
| 81601 |
| United States |
| Andrews Research & Education Foundation | Gulf Breeze | Florida | 32561 | United States |
| Andrews Sports Medicine & Orthopaedic Center | Gulf Breeze | Florida | 32561 | United States |
| Jacksonville Orthopaedic Institute | Jacksonville | Florida | 32204 | United States |
| Schofield, Hand, & Bright Orthopaedics | Sarasota | Florida | 34239 | United States |
| Harbin Clinic Orthopaedics & Sports Medicine Rome | Rome | Georgia | 30165 | United States |
| OrthoIllinois, LTD | Rockford | Illinois | 61107 | United States |
| Norton Orthopaedic & Sports | Louisville | Kentucky | 40241 | United States |
| Orthopaedic Surgical Associates | North Chelmsford | Massachusetts | 01863 | United States |
| Advanced Orthopedics of Detroit, PC | Saint Clair Shores | Michigan | 48080 | United States |
| Atlantic Orthopaedics & Sports Medicine | Portsmouth | New Hampshire | 03801 | United States |
| Lourdes Medical Associates (LMA) Professional | Burlington | New Jersey | 08016 | United States |
| Stony Brook Orthopaedics | Setauket | New York | 11733 | United States |
| Westchester Medical Pavilion | White Plains | New York | 10606 | United States |
| Hand and Microsurgery Associates | Columbus | Ohio | 43240 | United States |
| Central Texas Sports Medicine & Orthopaedics, PA | Bryan | Texas | 77802 | United States |
| Bone & Joint Clinic of Houston | Houston | Texas | 77030 | United States |
| Plano Orthopedic Sports Medicine & Spine Center | Plano | Texas | 75093 | United States |
| ID | Term |
|---|---|
| D000070636 | Rotator Cuff Injuries |
| ID | Term |
|---|---|
| D012421 | Rupture |
| D014947 | Wounds and Injuries |
| D000070599 | Shoulder Injuries |
| D013708 | Tendon Injuries |
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