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A Pilot Study of rhBMP-2/ACS With the INTERFIX™ Device for the AnteriorLumbar Interbody Fusion in Patients With Degenerative Disc Disease

NCT01491451 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2023-05-17

No results posted yet for this study

Summary

The purpose of this pilot clinical trial is to evaluate the device design as a method of facilitating spinal fusion.

Conditions

  • Degenerative Disc Disease

Interventions

DEVICE

rhBMP-2/ACS/INTERFIX™

INTERFIX™ device containing recombinant human Bone Morphogenetic Protein-2 (rhBMP-2) and the absorbable collagen sponge (ACS) carrier.

DEVICE

Autogenous bone/INTERFIX™

INTERFIX™ 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
1999-02-28
Primary Completion
2003-01-31
Completion
2003-01-31

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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 NCT01491451 on ClinicalTrials.gov