Clinical Trial: A Pilot Study of rhBMP-2/ACS/Allograft Bone Dowel for Anterior Lumbar Interbody Fusion in Patients With Symptomatic Degenerative Disc Disease

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Clinical Investigation of Recombinant Human Bone Morphogenetic Protein-2 and Absorbable Collagen Sponge With Allograft Bone Dowel for Anterior Lumbar Interbody Fusion in Patients With Symptomatic

Brief Summary: The purpose of this pilot clinical trial is to evaluate the device design as a method of facilitating spinal fusion.

Detailed Summary:
Sponsor: Medtronic Spinal and Biologics

Current Primary Outcome:

  • Severity and Rate of Implant-Associated Adverse Events [ Time Frame: 24 month ]
  • Rate of Implant Revision, Removal and Supplemental Fixation Procedures [ Time Frame: 24 month ]
  • Incidence of Permanent Adverse Events [ Time Frame: 24 month ]
  • Fusion [ Time Frame: 24 month ]

    Fusion is defined as:

    1. Bone observed connecting with the vertebral bodies above and below either through the implants; lateral to or between the implants; or anterior/posterior to the implants.
    2. Angulation < 5°.
    3. Translation < 3mm.
    4. Absence of radiolucent lines around more than 50% of either implant.
  • Disc Height Measurement [ Time Frame: 24 month ]
    Disc height will be measured postoperative and compared to the preoperative measurement. Maintenance or improvement in disc height will be determined a success.
  • Pain/Disability Status [ Time Frame: 24 month ]
    The self-administered Oswestry Low Back Pain Disability Questionnaire will be used. Success will be defined as pain/disability improvement postoperatively according to the following definition: Preoperative Score - Postoperative Score >= 15
  • Neurological Status [ Time Frame: 24 month ]
    Neurological stat

    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • Nature and Frequency of Adverse Events Not Associated with the Implants [ Time Frame: 24 month ]
    • Rate of Reoperation Procedures [ Time Frame: 24 month ]
    • Hip (Donor Site) Pain Status [ Time Frame: 24 month ]
    • Patient Satisfaction/Quality of Life Status (SF-36) [ Time Frame: 24 month ]
    • Pain Status (Numerical Rating Scale) [ Time Frame: 24 month ]
    • Overall Success [ Time Frame: 24 months ]

      A patient will be considered an overall success if all of the following conditions are met:

      1. fusion
      2. disc height maintenance or improvement
      3. pain/disability (Oswestry) improvement
      4. maintenance or improvement in neurological status
      5. no permanent adverse event
      6. no additional surgical procedure classified as a "failure."


    Original Secondary Outcome: Same as current

    Information By: Medtronic Spinal and Biologics

    Dates:
    Date Received: December 12, 2011
    Date Started: April 1998
    Date Completion:
    Last Updated: August 1, 2013
    Last Verified: December 2011