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

NCT01491542 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2023-05-17

No results posted yet for this study

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.

Conditions

  • Degenerative Disc Disease

Interventions

DEVICE

INFUSE® Bone Graft/MASTERGRAFT® Granules/CD HORIZON®

The INFUSE® Bone Graft component of the investigational device consists of recombinant human Bone Morphogenetic Protein-2(rhBMP-2) and an absorbable collagen sponge (ACS)carrier. The MASTERGRAFT® Granules will be used as a type of bulking agent to provide compression resistance.

DEVICE

Autogenous Bone / 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.

Sponsors & Collaborators

  • Medtronic Spinal and Biologics

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-04-30
Primary Completion
2006-11-30
Completion
2007-03-31

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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 NCT01491542 on ClinicalTrials.gov