Rotation Medical Bioinductive Implant Database Registry
- Conditions
- Rotator Cuff Tear
- Interventions
- Device: Bioinductive implant
- Registration Number
- NCT02784600
- Lead Sponsor
- Smith & Nephew, Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 483
- At least 21 years of age.
- Able and willing to provide voluntary consent to Registry participation.
- Able to read, speak, and understand the English language.
- Hypersensitive to bovine-derived materials.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Partial or full-thickness rotator cuff tear Bioinductive implant Rotation Medical bioinductive implant
- Primary Outcome Measures
Name Time Method American Shoulder and Elbow Surgeons Standardized Form for the Assessment of the Shoulder (ASES) 1 year Change between baseline and post-operative ASES shoulder score over time.
Western Ontario Rotator Cuff Index (WORC) 1 Year Change between baseline and post-operative WORC score over time.
Shoulder pain 1 year Change between baseline and post-operative shoulder pain over time using a Visual Analog Scale (VAS).
Single Assessment Numeric Evaluation (SANE) Score 1 year Change between baseline and post-operative SANE score over time.
Veterans RAND 12 Item Health Survey (VR-12) 1 year Change between baseline and post-operative VR-12 score over time.
- Secondary Outcome Measures
Name Time Method Recovery by cumulative time in days between discharge and return to work. 1 Year Recovery by cumulative number corticosteroid injections used to manage post-operative shoulder pain. 1 Year Recovery by cumulative number of days shoulder is in a sling 1 Year Safety assessed by number of Adverse Events and Serious Adverse Events. 1 Year 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
Recovery by cumulative time between discharge and return to driving 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 time days between discharge and return to overhead-throwing and non-overhead throwing sports 1 Year 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.
Revision Surgery 1 Year Number of participants with a revision surgery.
Trial Locations
- Locations (19)
OrthoIllinois, LTD
🇺🇸Rockford, Illinois, United States
Andrews Research & Education Foundation
🇺🇸Gulf Breeze, Florida, United States
Atlantic Orthopaedics & Sports Medicine
🇺🇸Portsmouth, New Hampshire, United States
Glenwood Orthopaedic Center
🇺🇸Glenwood Springs, Colorado, United States
Orthopaedic Specialty Institute
🇺🇸Orange, California, United States
Jacksonville Orthopaedic Institute
🇺🇸Jacksonville, Florida, United States
Norton Orthopaedic & Sports
🇺🇸Louisville, Kentucky, United States
Lourdes Medical Associates (LMA) Professional
🇺🇸Burlington, New Jersey, United States
Harbin Clinic Orthopaedics & Sports Medicine Rome
🇺🇸Rome, Georgia, United States
Westchester Medical Pavilion
🇺🇸White Plains, New York, United States
Central Texas Sports Medicine & Orthopaedics, PA
🇺🇸Bryan, Texas, United States
Andrews Sports Medicine & Orthopaedic Center
🇺🇸Gulf Breeze, Florida, United States
Stony Brook Orthopaedics
🇺🇸Setauket, New York, United States
Orthopaedic Surgical Associates
🇺🇸North Chelmsford, Massachusetts, United States
Plano Orthopedic Sports Medicine & Spine Center
🇺🇸Plano, Texas, United States
Schofield, Hand, & Bright Orthopaedics
🇺🇸Sarasota, Florida, United States
Hand and Microsurgery Associates
🇺🇸Columbus, Ohio, United States
Bone & Joint Clinic of Houston
🇺🇸Houston, Texas, United States
Advanced Orthopedics of Detroit, PC
🇺🇸Saint Clair Shores, Michigan, United States