Rotation MEdical BioindUctive ImpLant Database (REBUILD) Registry
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Rotator Cuff Tear
- Sponsor
- Smith & Nephew, Inc.
- Enrollment
- 483
- Locations
- 19
- Primary Endpoint
- American Shoulder and Elbow Surgeons Standardized Form for the Assessment of the Shoulder (ASES)
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •Hypersensitive to bovine-derived materials.
Outcomes
Primary Outcomes
American Shoulder and Elbow Surgeons Standardized Form for the Assessment of the Shoulder (ASES)
Time Frame: 1 year
Change between baseline and post-operative ASES shoulder score over time.
Western Ontario Rotator Cuff Index (WORC)
Time Frame: 1 Year
Change between baseline and post-operative WORC score over time.
Shoulder pain
Time Frame: 1 year
Change between baseline and post-operative shoulder pain over time using a Visual Analog Scale (VAS).
Single Assessment Numeric Evaluation (SANE) Score
Time Frame: 1 year
Change between baseline and post-operative SANE score over time.
Veterans RAND 12 Item Health Survey (VR-12)
Time Frame: 1 year
Change between baseline and post-operative VR-12 score over time.
Secondary Outcomes
- Recovery by cumulative number of days shoulder is in a sling(1 Year)
- Recovery by cumulative number corticosteroid injections used to manage post-operative shoulder pain.(1 Year)
- Safety assessed by number of Adverse Events and Serious Adverse Events.(1 Year)
- 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 in days between discharge and return to work.(1 Year)
- Recovery by cumulative time days between discharge and return to overhead-throwing and non-overhead throwing sports(1 Year)
- Revision Surgery(1 Year)