Clinical Trial: INFUSE® Bone Graft and MASTERGRAFT® Granules With CD HORIZON® for Posterolateral Lumbar Fusion in Patients With Degenerative Disc Disease - Pilot Study

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

Official Title: A Pilot Prospective Randomized Clinical Investigation of INFUSE® Bone Graft and MASTERGRAFT® Granules With the CD HORIZON® Spinal System for Posterolateral Lumbar Fusion in Patients Wit

Brief Summary: The purpose of this pilot clinical trial is to evaluate the feasibility of using the investigational implant (INFUSE® Bone Graft and MASTERGRAFT® Granules with the CD HORIZON® Spinal System) as a method of facilitating spinal fusion in patients with symptomatic degenerative disc disease.

Detailed Summary:
Sponsor: Medtronic Spinal and Biologics

Current Primary Outcome: 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. Postoperative Oswestry score improvement of at least 15% from preoperative;
  3. Maintenance or improvement in neurological status;
  4. No serious adverse event classified as implant associated or implant surgical procedure associated;
  5. No additional surgical procedure classified as a "failure".


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • General Health Status (SF-36) [ Time Frame: 24 months ]
  • Pain Status (back pain, leg pain) [ Time Frame: 24 months ]
  • Patient Satisfaction [ Time Frame: 24 months ]
  • Patient Global Perceived Effect [ Time Frame: 24 months ]


Original Secondary Outcome: Same as current

Information By: Medtronic Spinal and Biologics

Dates:
Date Received: December 12, 2011
Date Started: April 2003
Date Completion:
Last Updated: August 1, 2013
Last Verified: December 2011