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Clinical Study of rhBMP-2/BCP With the TSRH® Spinal System for Posterolateral Lumbar Fusion in Patients With Degenerative Disc Disease

NCT01494454 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 197

Last updated 2023-05-17

No results posted yet for this study

Summary

This study is designed to assess the safety and effectiveness of the rhBMP/BCP/TRSH Spinal System in treatment of the patients with degenerative disc disease.

Conditions

  • Degenerative Disc Disease

Interventions

DEVICE

rhBMP-2/BCP/TSRH® or rhBMP-2/BCP/CD HORIZON® Spinal System

rhBMP-2/BCP device will be used in conjunction with the posterior spinal fixation system, either the TSRH® Spinal System or CD HORIZON® Spinal System.

DEVICE

Autograft/TSRH® or autograft/CD HORIZON® Spinal System.

Either the TSRH® Spinal System or the CD HORIZON® Spinal System with autogenous bone taken from the patient's iliac crest.

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
1999-08-31
Primary Completion
2007-11-30
Completion
2007-11-30

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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 NCT01494454 on ClinicalTrials.gov