Clinical trial NCT00957255: Rotator Cuff Repair (RCR) With and Without OrthoADAPT Augmentation
Official title: Rotator Cuff Repair (RCR) With and Without OrthoADAPT Augmentation
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Rotator Cuff Tear
Keywords: rotator cuff tear
rotator cuff repair
Lead sponsor: Baxter Healthcare Corporation
Sponsor class: INDUSTRY
Collaborators: name: Synovis Surgical Innovations
First posted: 2009-08-12
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Passive and active range of motion
timeFrame: Pre-op, 6 weeks, 3, 4, 6, 12, and 24 months
measure: American Shoulder and Elbow Surgeons assessment score
timeFrame: Pre-op, 6 weeks, 3, 4, 6, 12, and 24 months
measure: Constant shoulder score
timeFrame: Pre-op, 6 weeks, 3, 4, 6, 12, and 24 months
measure: Pain
timeFrame: Pre-op, 2, 3, 4, and 6 weeks, 3, 4, 6, 12 and 24 months
Secondary outcomes:
measure: MRI
timeFrame: 12 months
measure: Rotator cuff re-rupture and adhesions
timeFrame: 6 weeks, 3, 4, 6, 12 and 24 months
measure: Incidence of device or procedure related adverse events
timeFrame: 6 weeks, 3, 4, 6, 12, and 24 months
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Seattle Medical Research Foundation
state: Washington
Study officials:
affiliation: Mission Health Research Institute
name: Charles DePaolo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Seattle Medical Research Foundation
name: Pierce Scranton, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Methodist Center for Orthopedic Surgery
name: William Bryan, MD
role: PRINCIPAL_INVESTIGATOR
References: