Rotator Cuff Repair (RCR) With and Without OrthoADAPT Augmentation

Not Applicable

Withdrawn

• Conditions: Rotator Cuff Tear
• Interventions: Procedure: Standard of care; Device: OrthoADAPT

• Registration Number: NCT00957255
• Lead Sponsor: Baxter Healthcare Corporation

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-08-11
• Study First Submitted QC: 2009-08-11
• Study First Posted: 2009-08-12
• Primary Completion: 2010-04
• Study Completion: 2010-04
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-04
• Last Update Posted: 2017-04-05

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
RCR without augmentation	Standard of care	Rotator cuff repair without OrthoADAPT augmentation
RCR with augmentation	OrthoADAPT	Rotator cuff repair with OrthoADAPT augmentation

Primary Outcome Measures

Name	Time	Method
Pain	Pre-op, 2, 3, 4, and 6 weeks, 3, 4, 6, 12 and 24 months
Passive and active range of motion	Pre-op, 6 weeks, 3, 4, 6, 12, and 24 months
American Shoulder and Elbow Surgeons assessment score	Pre-op, 6 weeks, 3, 4, 6, 12, and 24 months
Constant shoulder score	Pre-op, 6 weeks, 3, 4, 6, 12, and 24 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Seattle Medical Research Foundation; 🇺🇸 Seattle, Washington, United States