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

Sponsored by:	Exactech
Information provided by:	Exactech
ClinicalTrials.gov Identifier:	NCT00254852

Purpose

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.

Condition	Intervention
Stenosis Spondylolisthesis Degenerative Disc Disease	Procedure: Posterior Lateral Fusion (PLF) Procedure: Anterior Lumbar Interbody Fusion (ALIF) Procedure: Transforaminal lumbar interbody fusion (TLIF) Procedure: Posterior lumbar interbody fusion (PLIF) Procedure: Extreme lateral interbody fusion (XLIF)

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Parallel Assignment, Safety/Efficacy Study
Official Title:	A Single Blind, Multi-Center, Randomized, Prospective Clinical Study Comparing Optecure™ Autograft Extender to Autograft Only in Fusion of the Lumbar Spine

Resource links provided by NLM:

MedlinePlus related topics: X-Rays

U.S. FDA Resources

Further study details as provided by Exactech:

Primary Outcome Measures:

Radiographic evidence of fusion on x-rays taken at each post-op visit [ Time Frame: Immediate post-op, 6-week, 3-month, 6-month, 1-year, 2-year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Oswestry Disability Index (ODI) completed at each visit [ Time Frame: pre-operative, 6-week, 3-month, 6-month, 1-year, 2-year ] [ Designated as safety issue: No ]
SF-12 patient health surveys completed at each visit [ Time Frame: Pre-operative, 6-week, 3-month, 6-month, 1-year, 2-year ] [ Designated as safety issue: No ]
Perceived pain noted on visual analog scales (VAS) at each visit [ Time Frame: Pre-operative, 6-week, 3-month, 6-month, 1-year, 2-year ] [ Designated as safety issue: No ]

Enrollment:	94
Study Start Date:	October 2005
Estimated Study Completion Date:	January 2010
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
O: Active Comparator This treatment arm includes autograft harvested from local bone or the iliac crest, supplemented with a demineralized bone matrix (DBM) autograft extender, Optecure.	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)
A: Active Comparator This treatment arm includes autograft harvested from local bone or the iliac crest.	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)

Arms

Assigned Interventions

O: Active Comparator

This treatment arm includes autograft harvested from local bone or the iliac crest, supplemented with a demineralized bone matrix (DBM) autograft extender, Optecure.

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)

A: Active Comparator

This treatment arm includes autograft harvested from local bone or the iliac crest.

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)

Detailed Description:

Autograft (graft of 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 (graft of 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.

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patient is indicated for primary lumbar fusion of 1 or 2 segments, L2 to S1
Patient is willing to be blindly randomized to treatment or control and remain blinded for 2 years of follow-up
Patient is at least twenty-one (21) years of age
Patient is expected to survive at least 2 years beyond surgery
Patient is willing to participate by complying with pre- and postoperative visit requirements, including:

completion of questionnaires, functional performance tests, and radiographs/CT scan

Patient is willing and able to review and sign a study Informed Consent form

Exclusion Criteria:

Patient has a mental or physical condition that would invalidate evaluation results
Patient is pregnant
Patient is a prisoner
Patient has a systemic infection or infection at the proposed surgical site
Patient has osteopenia, osteoporosis, or osteomalacia to a degree that spinal instrumentation would be contraindicated
Patient has a disease of bone metabolism
Patient is undergoing chemotherapy or radiation treatment
Patient is currently involved in a study of another product for a similar purpose
Patient requires post-op management with nonsteroidal anti-inflammatory drugs (NSAIDs)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00254852

Locations

United States, California
University of California, San Diego
San Diego, California, United States, 92103
Memorial Orthopaedic Surgical Group
Long Beach, California, United States, 90806
United States, New York
State University of New York, Upstate Medical University
Syracuse, New York, United States, 13202
Slocum Dickson Medical Group
New Hartford, New York, United States, 13413
United States, Tennessee
NeuroSpine Solutions, P.C.
Bristol, Tennessee, United States, 37620
United States, Washington
Madigan Army Medical Center
Tacoma, Washington, United States, 98431

Sponsors and Collaborators

Exactech

Investigators

Principal Investigator:

Amir Fayyazi, MD

VSAS Orthopedics

More Information

No publications provided

Responsible Party:	Exactech, Inc. ( Matt Christensen )
Study ID Numbers:	CR04-004
Study First Received:	November 15, 2005
Last Updated:	September 15, 2008
ClinicalTrials.gov Identifier:	NCT00254852 History of Changes
Health Authority:	United States: Institutional Review Board; United States: Food and Drug Administration

Keywords provided by Exactech:

Primary lumbar fusion
Demineralized Bone Matrix
DBM
Optecure
Allograft
Autograft

Lumbar fusion
Interbody fusion
Instrumented fusion
Non-instrumented fusion
Exactech
Spinal fusion

Study placed in the following topic categories:

Spinal Diseases
Musculoskeletal Diseases
Constriction, Pathologic
Spondylolisthesis
Bone Diseases

Additional relevant MeSH terms:

Spinal Diseases
Musculoskeletal Diseases
Spondylolisthesis
Bone Diseases

ClinicalTrials.gov processed this record on September 02, 2009