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

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: NCT01256242
Recruitment Status : Unknown
Verified May 2011 by BioMimetic Therapeutics.
Recruitment status was:  Active, not recruiting
First Posted : December 8, 2010
Last Update Posted : May 30, 2011
Information provided by:
BioMimetic Therapeutics

Brief Summary:

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 or disease Intervention/treatment Phase
Full Thickness Rotator Cuff Tear Device: Augment Rotator Cuff Procedure: Standard Suture Repair Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : November 2010
Estimated Primary Completion Date : June 2011
Estimated Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Safety [ Time Frame: 24 weeks ]
    Evaluated by type, frequency, severity, and relatedness of adverse events to device and control

  2. Performance [ Time Frame: 24 weeks ]
    MRI will be done at baseline, 12 and 24 weeks

Secondary Outcome Measures :
  1. Clinical Outcome Measurements [ Time Frame: 24 weeks ]
    DASH questionnaire and WORC questionnaire will be collected at baseline, 6, 12, and 24 weeks post-operatively

  2. Implantation [ Time Frame: 24 weeks ]
    Information related to the implantation procedure of the device

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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): NCT01256242

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

Additional Information:
Responsible Party: Gerda P. Resch, RAC, CQA, CBA, BioMimetic Therapeutics, Inc Identifier: NCT01256242     History of Changes
Other Study ID Numbers: BMTI-2010-03
First Posted: December 8, 2010    Key Record Dates
Last Update Posted: May 30, 2011
Last Verified: May 2011

Keywords provided by BioMimetic Therapeutics:
rotator cuff

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