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Rotator Cuff Repair (RCR) With and Without OrthoADAPT Augmentation

This study has been withdrawn prior to enrollment.
(Funding withdrawn)
Synovis Surgical Innovations
Information provided by (Responsible Party):
Baxter Healthcare Corporation Identifier:
First received: August 11, 2009
Last updated: April 4, 2017
Last verified: April 2017
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 Intervention
Rotator Cuff Tear Device: OrthoADAPT Procedure: Standard of care

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Baxter Healthcare Corporation:

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

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

Enrollment: 0
Study Start Date: March 2009
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

Responsible Party: Baxter Healthcare Corporation Identifier: NCT00957255     History of Changes
Other Study ID Numbers: O-0803
Study First Received: August 11, 2009
Last Updated: April 4, 2017

Keywords provided by Baxter Healthcare Corporation:
rotator cuff tear
rotator cuff repair processed this record on August 18, 2017