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.
Study Type
OBSERVATIONAL
Enrollment
483
Orthopaedic Specialty Institute
Orange, California, United States
Shoulder pain
Change between baseline and post-operative shoulder pain over time using a Visual Analog Scale (VAS).
Time frame: 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.
Time frame: 1 year
Single Assessment Numeric Evaluation (SANE) Score
Change between baseline and post-operative SANE score over time.
Time frame: 1 year
Veterans RAND 12 Item Health Survey (VR-12)
Change between baseline and post-operative VR-12 score over time.
Time frame: 1 year
Western Ontario Rotator Cuff Index (WORC)
Change between baseline and post-operative WORC score over time.
Time frame: 1 Year
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
Time frame: 1 Year
Recovery by cumulative number of days shoulder is in a sling
Time frame: 1 Year
Recovery by cumulative time in days between discharge and return to work.
Time frame: 1 Year
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Recovery by cumulative time between discharge and return to driving
Time frame: 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.
Time frame: 1 Year
Recovery by cumulative number physical therapy (PT) visits to rehabilitate the index shoulder.
Time frame: 1 Year
Recovery by cumulative number of days of narcotic medication use to manage post-operative shoulder pain.
Time frame: 1 Year
Recovery by cumulative number corticosteroid injections used to manage post-operative shoulder pain.
Time frame: 1 Year
Revision Surgery
Number of participants with a revision surgery.
Time frame: 1 Year