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Rotator Cuff Repair (RCR) With and Without OrthoADAPT Augmentation

This study has been terminated.
(Funding withdrawn)
Sponsor:
Information provided by:
Synovis Surgical Innovations
ClinicalTrials.gov Identifier:
NCT00957255
First received: August 11, 2009
Last updated: December 8, 2009
Last verified: December 2009
History of Changes
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Rotator Cuff Repair (RCR) With and Without OrthoADAPT Augmentation

Further study details as provided by Synovis Surgical Innovations:

Primary Outcome Measures:
  • Passive and active range of motion [ Time Frame: Pre-op, 6 weeks, 3, 4, 6, 12, and 24 months ] [ Designated as safety issue: No ]
  • American Shoulder and Elbow Surgeons assessment score [ Time Frame: Pre-op, 6 weeks, 3, 4, 6, 12, and 24 months ] [ Designated as safety issue: No ]
  • Constant shoulder score [ Time Frame: Pre-op, 6 weeks, 3, 4, 6, 12, and 24 months ] [ Designated as safety issue: No ]
  • Pain [ Time Frame: Pre-op, 2, 3, 4, and 6 weeks, 3, 4, 6, 12 and 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • MRI [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Rotator cuff re-rupture and adhesions [ Time Frame: 6 weeks, 3, 4, 6, 12 and 24 months ] [ Designated as safety issue: No ]
  • Incidence of device or procedure related adverse events [ Time Frame: 6 weeks, 3, 4, 6, 12, and 24 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 90
Study Start Date: March 2009
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: December 2011 (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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00957255

Locations
United States, Washington
Seattle Medical Research Foundation
Seattle, Washington, United States, 98104
Sponsors and Collaborators
Synovis Surgical Innovations
Investigators
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

No publications provided

Responsible Party: Kristi Winterfeldt, Manager of Clinical Affairs, Synovis Surgical Innovations
ClinicalTrials.gov Identifier: NCT00957255     History of Changes
Other Study ID Numbers: O-0803
Study First Received: August 11, 2009
Last Updated: December 8, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Synovis Surgical Innovations:
rotator cuff tear
rotator cuff repair

ClinicalTrials.gov processed this record on May 23, 2013