MedTrace Logo

Evaluation of Radiographic and Patient Outcomes Following Lumbar Spine Fusion Using Demineralized Bone Matrix (DBM) Mixed With Autograft

NCT00254852 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 94

Last updated 2013-11-21

No results posted yet for this study

Summary

The purpose of this study is to compare Optecure™ as an autograft extender (treatment) to autograft alone (control) in patients undergoing 1 or 2 level fusion of the lumbar spine(one level is defined as two adjacent vertebrae), L2 and below.

The primary endpoint will be the assessment of fusion by evaluation of x-rays taken following surgery at each visit. The x-ray evaluation will be conducted by a radiologist who is blinded to the type of treatment each patient has received.

Subjects will be seen at 6 weeks, 3 months, 6 months, 12 months, and 24 months postoperative (post-op). Questionnaires and x-rays will be completed at each visit and a computed tomography (CT) scan will be taken at the 12 month visit(and used to aid in assessment of bridging bone, where appropriate).

Conditions

  • Stenosis
  • Spondylolisthesis
  • Degenerative Disc Disease

Interventions

PROCEDURE

Posterior Lateral Fusion (PLF)

Posterior lateral fusion (PLF) of the lumbar spine

PROCEDURE

Anterior Lumbar Interbody Fusion (ALIF)

Anterior lumbar interbody fusion (ALIF)

PROCEDURE

Transforaminal lumbar interbody fusion (TLIF)

Transforaminal lumbar interbody fusion (TLIF)

PROCEDURE

Posterior lumbar interbody fusion (PLIF)

Posterior lumbar interbody fusion (PLIF)

PROCEDURE

Extreme lateral interbody fusion (XLIF)

Extreme lateral interbody fusion (XLIF)

Sponsors & Collaborators

  • Exactech

    lead INDUSTRY

Principal Investigators

  • Amir Fayyazi, MD · VSAS Orthopedics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-10-31
Primary Completion
2011-08-31
Completion
2011-08-31

Countries

  • United States

Study Locations

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 NCT00254852 on ClinicalTrials.gov