MedTrace Logo

A Pivotal Study of rhBMP-2/ACS/INTER FIX™ Device for Posterior Lumbar Interbody Fusion in Patients With Degenerative Disc Disease

NCT01491464 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2023-05-17

No results posted yet for this study

Summary

The purpose of this clinical trial is to assess the safety and effectiveness of the rhBMP-2/ACS/INTER FIX™ device as compared to the autograft/INTER FIX™ device in patients with symptomatic degenerative disease.

Conditions

  • Degenerative Disc Disease

Interventions

DEVICE

rhBMP-2/ACS/INTER FIX™

The INTER FIX™ device containing recombinant human Bone Morphogenetic Protein (rhBMP-2) soaked into an absorbable collagen sponge (ACS).

DEVICE

Autogenous bone/INTER FIX™

The INTER FIX™ device containing 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
1999-03-31
Primary Completion
2002-09-30
Completion
2002-09-30

More Related Trials

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 NCT01491464 on ClinicalTrials.gov