NCT00254852

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

A Single Blind, Multi-Center, Randomized, Prospective Clinical Study Comparing Optecure™ Autograft Extender to Autograft Only in Fusion of the Lumbar Spine

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 94 (actual)
• Sponsor: Exactech · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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).

Detailed description

Autograft (bone taken from one part of the body and placed in another site on the same individual) has long been considered the gold standard for lumbar spine fusion procedures. Unfortunately, there are complications involved with autograft harvest such as donor site morbidity, increased operating time, and limited supply. Therefore, the use of allograft (bone taken from one body and placed into another individual) as a graft extender has become an acceptable practice, especially in fusions of more than one level where larger quantities of graft material are needed. In this study, comparisons will be made between patients who are randomized to having fusion with an allograft material (Optecure, Exactech, Inc.) mixed with an autograft to those patients who are randomized to having fusion with autograft alone.

Conditions

• Stenosis
• Spondylolisthesis
• Degenerative Disc Disease

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2005-10-01
• Primary completion: 2011-08-01
• Completion: 2011-08-01
• First posted: 2005-11-17
• Last updated: 2013-11-21

Locations

6 sites across 1 country: United States