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rhBMP-2/CRM/CD HORIZON® Spinal System Pivotal Study

NCT00707265 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 463

Last updated 2023-05-10

No results posted yet for this study

Summary

The purpose of this study was to evaluate the rhBMP-2/CRM/CD HORIZON® Spinal System as a method of facilitating spinal fusion in patients with degenerative disc disease.

Conditions

  • Degenerative Disc Disease

Interventions

DEVICE

rhBMP-2/CRM/CD HORIZON® Spinal System

The rhBMP-2/CRM component of the investigational device consists of recombinant human Bone Morphogenetic Protein-2 (rhBMP-2) and a compression resistant matrix (CRM) carrier consisting of an absorbable collagen sponge imbedded with biphasic calcium phosphate. The posterior spinal fixation system, the CD HORIZON® Spinal System, is a commercially available rod-based spinal system intended for temporary stabilization of the spine in order to facilitate fusion. The CD HORIZON® Spinal System is available in either titanium or stainless steel. For this study, only titanium implant components will be used.

DEVICE

Autograft/CD HORIZON® Spinal System

The control will be autogenous bone taken from the iliac crest of the patient and placed bilaterally across two adjacent transverse processes and used in conjunction with the CD HORIZON® Spinal System. When used as a posterior spine thoracic/lumbar system, the CD HORIZON® CANNULATED M8 MULTI-AXIAL SCREW components are intended for several indications including degenerative disc disease.

Sponsors & Collaborators

  • Medtronic Spinal and Biologics

    lead INDUSTRY

Principal Investigators

  • Kenneth Burkus, MD · The Hughston Clinic, P.C.

  • John Dimar, MD · Spine Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-03-31
Primary Completion
2005-05-31
Completion
2010-02-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00707265 on ClinicalTrials.gov