NCT00957255WithdrawnNot Applicable
Rotator Cuff Repair (RCR) With and Without OrthoADAPT Augmentation
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Locations
- 2
- Primary Endpoint
- Pain
Study Overview
Brief Summary
Prospective, randomized, multi-center, controlled study for patients undergoing open rotator cuff repair. Patients are stratified based on tear size to one of three groups. Each group is then randomized 1:1 to either repair with OrthoADAPT or repair without OrthoADAPT.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Ages 18-70
- •MRI confirmed full thickness or high grade partial thickness rotator cuff tear equal or more than 1 cm and involving the supraspinatus and/or infraspinatus tendons
- •Tear is repairable by surgery using protocol prescribed fixation procedure
- •Patient is able to sign and IRB approved study informed consent
- •Patient is willing and able to return for follow-up appointments and study related procedures
- •Patient is willing to comply with prescribed physical therapy regimen
Exclusion Criteria
- •Emergency, poly trauma patients
- •Prior same shoulder surgery including rotator cuff repair except prior subacromial decompression or distal clavicle resection
- •Shoulder pathology requiring concomitant procedures during the rotator cuff repair including Labral repair, anterior or posterior stabilization, and/or capsular plication or shift
- •Cervical spine disease
- •History of adhesive capsulitis in either shoulder
- •Patient whose injury does or may involve litigation
- •Diabetics
- •Rotator cuff tear cannot be repaired by primary surgical means including superiorly migrated humeral head, retracted rotator cuff that cannot be mobilized to humeral head, end stage tears, rotator cuff tissue cannot retain sutures, any comorbidities that would directly or indirectly affect the reparability of the cuff
- •Patients with grade 3 or 4 glenohumeral arthritis
- •Patients with systemic collage disease
- •Patients with a known hypersensitivity to equine derived materials
- •Active or latent infection
- •Chronic use of immunosuppressive agents
- •Any oral or IM NSAID usage within 5 days before surgery
- •Cancer patients
- •Decisional impaired patients
- •Pregnant women
Outcomes
Primary Outcomes
Pain
Time Frame: Pre-op, 2, 3, 4, and 6 weeks, 3, 4, 6, 12 and 24 months
Passive and active range of motion
Time Frame: Pre-op, 6 weeks, 3, 4, 6, 12, and 24 months
American Shoulder and Elbow Surgeons assessment score
Time Frame: Pre-op, 6 weeks, 3, 4, 6, 12, and 24 months
Constant shoulder score
Time Frame: Pre-op, 6 weeks, 3, 4, 6, 12, and 24 months
Secondary Outcomes
- MRI(12 months)
- Rotator cuff re-rupture and adhesions(6 weeks, 3, 4, 6, 12 and 24 months)
- Incidence of device or procedure related adverse events(6 weeks, 3, 4, 6, 12, and 24 months)
Investigators
Study Sites (2)
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