Rotator Cuff Repair (RCR) With and Without OrthoADAPT Augmentation

Rotator Cuff Tear Clinical Trial

Official title:

Rotator Cuff Repair (RCR) With and Without OrthoADAPT Augmentation

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00957255
• Other study ID #: O-0803
• Status: Withdrawn
• Phase: N/A
• First received: August 11, 2009
• Last updated: April 4, 2017
• Start date: March 2009
• Est. completion date: April 2010

Study information

• Verified date: April 2017
• Source: Baxter Healthcare Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Rotator Cuff Tear

Intervention

Device:
• OrthoADAPT
soft tissue augmentation device

Procedure:
• Standard of care
Standard of care rotator cuff repair

Locations

Country	Name	City	State
United States	Seattle Medical Research Foundation	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Baxter Healthcare Corporation	Synovis Surgical Innovations

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Passive and active range of motion		Pre-op, 6 weeks, 3, 4, 6, 12, and 24 months
Primary	American Shoulder and Elbow Surgeons assessment score		Pre-op, 6 weeks, 3, 4, 6, 12, and 24 months
Primary	Constant shoulder score		Pre-op, 6 weeks, 3, 4, 6, 12, and 24 months
Primary	Pain		Pre-op, 2, 3, 4, and 6 weeks, 3, 4, 6, 12 and 24 months
Secondary	MRI		12 months
Secondary	Rotator cuff re-rupture and adhesions		6 weeks, 3, 4, 6, 12 and 24 months
Secondary	Incidence of device or procedure related adverse events		6 weeks, 3, 4, 6, 12, and 24 months