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

NCT01491386 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 279

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-2/ACS/LT-CAGE® device as compared to the LT-CAGE® device with autogenous bone in patients with symptomatic degenerative disc disease using an open surgical technique.

Conditions

  • Degenerative Disc Disease

Interventions

DEVICE

rhBMP-2/ACS/LT-CAGE® Device

LT-CAGE® device with recombinant human bone morphogenetic protein-2 ( rhBMP-2) and the absorbable collagen sponge (ACS).

DEVICE

Autogenous Bone/LT-CAGE® Device

LT-CAGE® device with autogenous bone taken from the 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
1998-08-31
Primary Completion
2002-10-31
Completion
2002-10-31

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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 NCT01491386 on ClinicalTrials.gov