Status:
WITHDRAWN
Rotator Cuff Repair (RCR) With and Without OrthoADAPT Augmentation
Lead Sponsor:
Baxter Healthcare Corporation
Collaborating Sponsors:
Synovis Surgical Innovations
Conditions:
Rotator Cuff Tear
Eligibility:
All Genders
18-70 years
Phase:
NA
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 randomiz...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00957255
Start Date
March 1 2009
End Date
April 1 2010
Last Update
April 5 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Seattle Medical Research Foundation
Seattle, Washington, United States, 98104