Rotation Medical Bioinductive Implant Database Registry

Study Overview
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Brief Summary
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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.

Official Title
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Rotation MEdical BioindUctive ImpLant Database (REBUILD) Registry

Conditions
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Rotator Cuff Tear

Intervention / Treatment
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* Device: Bioinductive implant


Participation Criteria
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Eligibility Criteria
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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: 1. Hypersensitive to bovine-derived materials.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Partial or full-thickness rotator cuff tear<br>Rotation Medical bioinductive implant | Device: Bioinductive implant<br> <br> * Other names: Rotation Medical Rotator Cuff System™;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Partial-thickness, Full-thickness