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Safety and Efficacy Study of Healos as a Bone Replacement to Treat Degenerative Disc Disease

NCT00316121 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 138

Last updated 2011-03-03

Study results available
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Summary

The purpose of this study is to determine the safety and effectiveness of HEALOS compared with autograft using the transforaminal lumbar interbody fusion (TLIF) method.

Conditions

  • Degenerative Disc Disease

Interventions

DEVICE

HEALOS and Leopard Cage

Placement in interbody space

DEVICE

Leopard Cage and Autograft

Placement in the interbody space

Sponsors & Collaborators

  • DePuy Spine

    collaborator INDUSTRY

  • Advanced Technologies and Regenerative Medicine, LLC (ATRM)

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-04-30
Primary Completion
2010-01-31

Countries

  • United States

Study Locations

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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 NCT00316121 on ClinicalTrials.gov