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Pilot Study of rhBMP-2/ACS/LT-CAGE® for Anterior Lumbar Interbody Fusion in Patients With Degenerative Disc Disease

NCT01491373 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2013-08-02

No results posted yet for this study

Summary

This study is designed to evaluate the feasibility of recombinant human bone morphogenetic protein-2 and absorbable collagen sponge with the tapered interbody fusion device (LT-CAGE® ) for anterior lumbar interbody fusion in patients with degenerative disc disease.

Conditions

  • Degeneration of Lumbar Intervertebral Disc

Interventions

DEVICE

rhBMP-2/ACS/LT-CAGE® Device

rhBMP-2/ACS inserted into Sofamor Danek's LT-CAGE® device.

DEVICE

Autograft/LT-CAGE® Device

LT-CAGE® device filled 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
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1997-01-31
Primary Completion
1999-09-30
Completion
1999-09-30

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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 NCT01491373 on ClinicalTrials.gov