Clinical Trial: Pilot Study of rhBMP/BCP With or Without the TSRH® Spinal System for Posterolateral Lumbar Fusion in Patients With Degenerative Disc Disease

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

Official Title: A Pilot Study of Recombinant Human Bone Morphogenetic Protein-2 and Biphasic Calcium Phosphate With or Without the TSRH® Spinal System for Posterolateral Lumbar Fusion in Patients With Symptomati

Brief Summary: The purpose of this pilot clinical trial is to evaluate both device designs (rhBMP-2/BCP and rhBMP-2/BCP/TSRH® spinal System) as methods of facilitating spinal fusion as compared to instrumented fusion with autograft in patients with symptomatic degenerative disc disease.

Detailed Summary:
Sponsor: Medtronic Spinal and Biologics

Current Primary Outcome:

  • Fusion [ Time Frame: 24 month ]

    Fusion is defined as:

    1. Evidence of bridging trabecular bone.
    2. No evidence of motion as defined by: a. No more than 3mm difference in translation on the lateral flexion/extension radiographs determined by superimposing the two views, one upon the other; b. Less than 5° difference in angular motion between flexion and extension as seen on the lateral flexion/extension radiographs;
    3. Absence of radiolucent lines completely through the fusion mass.
  • Pain/Disability Status [ Time Frame: 24 month ]
    The self-administered Oswestry Low Back pain Disability Questionnaire will be used. Success for each individual patient will be defined as pain/disability improvement postoperatively according to the following definition: Preoperative Score - Postoperative Score >= 15


Original Primary Outcome:

  • Fusion [ Time Frame: 24 month ]

    Fusion is defined as:

    1. Evidence of bridging trabecular bone.
    2. No evidence of motion as defined by: a. No more than 3mm difference in translation on the lateral flexion/extension radiographas determined by superimposing the two views, one upon the other; b. Less than 5° difference in angular motion between flexion and extension as seen on the lateral flexion/extension radiographs;
    3. Absence of radiolucent lines completely through the fusion mass.
  • Pain/Disability Status [ Time Frame: 24 month ]
    The self-administered Oswestry Low Back pain Disability Questionnaire will be used. Success for each individual patient will be defined as pain/disability improvement postoperatively according to the following definition: Preoperative Score - Postoperative Score >= 15


Current Secondary Outcome:

  • Neurological Status Success [ Time Frame: 24 month ]
    Neurological status will be assessed preoperatively and postoperatively using a comprehensive neurological status scale. Neurological status is based on four types of measurements (sections): motor, sensory, reflexes and straight leg raise.
  • Hip (Donor Site) Pain [ Time Frame: 24 month ]
  • General Health Status (SF-36) [ Time Frame: 24 month ]
  • Pain Status (back pain, leg pain) [ Time Frame: 24 month ]
  • Patient Satisfaction [ Time Frame: 24 month ]
  • Patient Global Perceived Effect [ Time Frame: 24 month ]
  • Overall Success [ Time Frame: 24 month ]


Original Secondary Outcome: Same as current

Information By: Medtronic Spinal and Biologics

Dates:
Date Received: December 12, 2011
Date Started: May 1999
Date Completion:
Last Updated: August 1, 2013
Last Verified: December 2011