Rotator Cuff Tear
Conditions
Keywords
Partial-thickness, Full-thickness
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.
Interventions
DEVICEBioinductive implant
Sponsors
Smith & Nephew, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. At least 21 years of age. 2. Able and willing to provide voluntary consent to Registry participation. 3. Able to read, speak, and understand the English language.
Exclusion criteria
1\. Hypersensitive to bovine-derived materials.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Shoulder pain | 1 year | Change between baseline and post-operative shoulder pain over time using a Visual Analog Scale (VAS). |
| 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. |
| 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. |
| Western Ontario Rotator Cuff Index (WORC) | 1 Year | Change between baseline and post-operative WORC score over time. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| 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 |
| Revision Surgery | 1 Year | Number of participants with a revision surgery. |
| 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 | — |
| 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 | 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. |
Countries
United States
Outcome results
None listed