Rotator Cuff Repair (RCR) With and Without OrthoADAPT Augmentation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00957255
Recruitment Status : Withdrawn (Funding withdrawn)
First Posted : August 12, 2009
Last Update Posted : April 5, 2017
Synovis Surgical Innovations
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Rotator Cuff Tear Device: OrthoADAPT Procedure: Standard of care Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Rotator Cuff Repair (RCR) With and Without OrthoADAPT Augmentation
Study Start Date : March 2009
Actual Primary Completion Date : April 2010
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: RCR without augmentation
Rotator cuff repair without OrthoADAPT augmentation
Procedure: Standard of care
Standard of care rotator cuff repair
Experimental: RCR with augmentation
Rotator cuff repair with OrthoADAPT augmentation
Device: OrthoADAPT
soft tissue augmentation device

Primary Outcome Measures :
  1. Passive and active range of motion [ Time Frame: Pre-op, 6 weeks, 3, 4, 6, 12, and 24 months ]
  2. American Shoulder and Elbow Surgeons assessment score [ Time Frame: Pre-op, 6 weeks, 3, 4, 6, 12, and 24 months ]
  3. Constant shoulder score [ Time Frame: Pre-op, 6 weeks, 3, 4, 6, 12, and 24 months ]
  4. Pain [ Time Frame: Pre-op, 2, 3, 4, and 6 weeks, 3, 4, 6, 12 and 24 months ]

Secondary Outcome Measures :
  1. MRI [ Time Frame: 12 months ]
  2. Rotator cuff re-rupture and adhesions [ Time Frame: 6 weeks, 3, 4, 6, 12 and 24 months ]
  3. Incidence of device or procedure related adverse events [ Time Frame: 6 weeks, 3, 4, 6, 12, and 24 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00957255

United States, Washington
Seattle Medical Research Foundation
Seattle, Washington, United States, 98104
Sponsors and Collaborators
Baxter Healthcare Corporation
Synovis Surgical Innovations
Principal Investigator: Charles DePaolo, MD Mission Health Research Institute
Principal Investigator: Pierce Scranton, MD Seattle Medical Research Foundation
Principal Investigator: William Bryan, MD Methodist Center for Orthopedic Surgery

Responsible Party: Baxter Healthcare Corporation Identifier: NCT00957255     History of Changes
Other Study ID Numbers: O-0803
First Posted: August 12, 2009    Key Record Dates
Last Update Posted: April 5, 2017
Last Verified: April 2017

Keywords provided by Baxter Healthcare Corporation:
rotator cuff tear
rotator cuff repair

Additional relevant MeSH terms:
Rotator Cuff Injuries
Wounds and Injuries
Shoulder Injuries
Tendon Injuries