Pilot Study of Augment Rotator Cuff for Surgical Treatment of Full Thickness Rotator Cuff Tears

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by BioMimetic Therapeutics.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
BioMimetic Therapeutics
ClinicalTrials.gov Identifier:
NCT01256242
First received: December 7, 2010
Last updated: May 27, 2011
Last verified: May 2011
  Purpose

Study Purpose: To evaluate the safety and performance of Augment Rotator Cuff as a primary surgical treatment for full thickness rotator cuff tears. The hypothesis is that Augment Rotator Cuff will be easy to deliver as an inter-positional graft placed between the rotator cuff tendon and the humeral head providing further enhanced tendon to bone healing without adding any additional safety risk to the patient.

Study Rationale: To evaluate the safety and performance Augment™ Rotator Cuff in surgical intervention of a torn rotator cuff and to obtain preliminary data to support the rationale for a subsequent pivotal clinical trial.


Condition Intervention Phase
Full Thickness Rotator Cuff Tear
Device: Augment Rotator Cuff
Procedure: Standard Suture Repair
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Single Blinded, Multi-center, Randomized, Controlled, Pilot Study to Evaluate the Safety and Performance of Augment™ Rotator Cuff for Primary Surgical Treatment of Full Thickness Rotator Cuff Tears

Further study details as provided by BioMimetic Therapeutics:

Primary Outcome Measures:
  • Safety [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
    Evaluated by type, frequency, severity, and relatedness of adverse events to device and control

  • Performance [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    MRI will be done at baseline, 12 and 24 weeks


Secondary Outcome Measures:
  • Clinical Outcome Measurements [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    DASH questionnaire and WORC questionnaire will be collected at baseline, 6, 12, and 24 weeks post-operatively

  • Implantation [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Information related to the implantation procedure of the device


Estimated Enrollment: 30
Study Start Date: November 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1
Standard Suture Repair + Augment Rotator Cuff
Device: Augment Rotator Cuff
rhPDGF-BB and bovine collagen matrix
Active Comparator: Group 2
Standard Suture Repair
Procedure: Standard Suture Repair
standard suture repair

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The subject has a repairable rotator cuff tear with an estimated full thickness size of ≥ 2 cm to < 5 cm confirmed with diagnostic MRI in AP or ML dimension
  • The subject is independent, ambulatory, and can comply with all post-operative evaluations and visits
  • The subject is at least twenty one (21) years of age and considered to be skeletally mature.

Exclusion Criteria:

  • The subject has undergone previous rotator cuff repair surgery to the affected shoulder
  • The subject has a partial thickness rotator cuff tear
  • The subject requires a concomitant subscapularis repair
  • The subject requires a concomitant labral repair
  • The subject has an irreparable rotator cuff tear
  • The subject has an allergy to yeast-derived products or a known bovine collagen allergy
  • The subject has implanted metallic devices (cardiac pacemakers, insulin pumps, and nerve stimulators), medically implanted clips or other electronically, magnetically or mechanically activated implants that would contraindicate undergoing an MRI scan of the shoulder
  • The subject has tested positive or has been treated for a malignancy in the past or is suspected of having a malignancy or is currently undergoing radiation or chemotherapy treatment for a malignancy anywhere in the body, whether adjacent to or distant from the proposed Augment Rotator Cuff implantation site
  • The subject's condition represents a worker's compensation case
  • The subject is currently involved in a health-related litigation procedure
  • The subject is pregnant or able to become pregnant but not practicing a medically-accepted form of birth control, and/or intending to become pregnant during this study period
  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 ClinicalTrials.gov identifier: NCT01256242

Locations
Canada, Ontario
Hand and Upper Limb Clinic - St. Joseph's Health Care London
London, Ontario, Canada, N6A 4L6
Fowler Kennedy Sports Medicine Clinic
London, Ontario, Canada, N6A 3K7
Ottawa Hospital
Ottawa, Ontario, Canada
St. Michaels Hospital
Toronto, Ontario, Canada
Sponsors and Collaborators
BioMimetic Therapeutics
Investigators
Principal Investigator: Robert Litchfield, MD, FRCSC Fowler Kennedy Sport Medicine Clinic
  More Information

Additional Information:
No publications provided

Responsible Party: Gerda P. Resch, RAC, CQA, CBA, BioMimetic Therapeutics, Inc
ClinicalTrials.gov Identifier: NCT01256242     History of Changes
Other Study ID Numbers: BMTI-2010-03
Study First Received: December 7, 2010
Last Updated: May 27, 2011
Health Authority: Canada: Health Canada

Keywords provided by BioMimetic Therapeutics:
tendon
shoulder
rotator cuff
Glenohumeral

ClinicalTrials.gov processed this record on August 20, 2014