Rotator Cuff Repair (RCR) With and Without OrthoADAPT Augmentation

Baxter

Status: Withdrawn

Conditions: Rotator Cuff Tear

Treatments: Device: OrthoADAPT; Procedure: Standard of care

Study type: Interventional

Funder types: Industry

Identifiers

NCT00957255

O-0803

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

RCR without augmentation

Active Comparator group

Description:

Rotator cuff repair without OrthoADAPT augmentation

Treatment:

Procedure: Standard of care

RCR with augmentation

Experimental group

Description:

Rotator cuff repair with OrthoADAPT augmentation

Treatment:

Device: OrthoADAPT