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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

December 7, 2010
May 27, 2011
November 2010
June 2011   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01256242 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Pilot Study of Augment Rotator Cuff for Surgical Treatment of Full Thickness Rotator Cuff Tears
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 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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Full Thickness Rotator Cuff Tear
  • Device: Augment Rotator Cuff
    rhPDGF-BB and bovine collagen matrix
  • Procedure: Standard Suture Repair
    standard suture repair
  • Experimental: Group 1
    Standard Suture Repair + Augment Rotator Cuff
    Intervention: Device: Augment Rotator Cuff
  • Active Comparator: Group 2
    Standard Suture Repair
    Intervention: Procedure: Standard Suture Repair
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
30
December 2011
June 2011   (final data collection date for primary outcome measure)

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
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01256242
BMTI-2010-03
No
Gerda P. Resch, RAC, CQA, CBA, BioMimetic Therapeutics, Inc
BioMimetic Therapeutics
Not Provided
Principal Investigator: Robert Litchfield, MD, FRCSC Fowler Kennedy Sport Medicine Clinic
BioMimetic Therapeutics
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP