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

This study has been terminated.
(Slow enrollment)
Sponsor:
Information provided by (Responsible Party):
Exactech
ClinicalTrials.gov Identifier:
NCT00254852
First received: November 15, 2005
Last updated: November 20, 2013
Last verified: November 2013
  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(and used to aid in assessment of bridging bone, where appropriate).


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: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
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:


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
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: O
This treatment arm includes autograft harvested from local bone and / 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
Other Name: PLF
Procedure: Anterior Lumbar Interbody Fusion (ALIF)
Anterior lumbar interbody fusion (ALIF)
Other Name: ALIF
Procedure: Transforaminal lumbar interbody fusion (TLIF)
Transforaminal lumbar interbody fusion (TLIF)
Other Name: TLIF
Procedure: Posterior lumbar interbody fusion (PLIF)
Posterior lumbar interbody fusion (PLIF)
Other Name: PLIF
Procedure: Extreme lateral interbody fusion (XLIF)
Extreme lateral interbody fusion (XLIF)
Other Name: XLIF
Active Comparator: A
This treatment arm includes autograft harvested from local bone and / or the iliac crest.
Procedure: Posterior Lateral Fusion (PLF)
Posterior lateral fusion (PLF) of the lumbar spine
Other Name: PLF
Procedure: Anterior Lumbar Interbody Fusion (ALIF)
Anterior lumbar interbody fusion (ALIF)
Other Name: ALIF
Procedure: Transforaminal lumbar interbody fusion (TLIF)
Transforaminal lumbar interbody fusion (TLIF)
Other Name: TLIF
Procedure: Posterior lumbar interbody fusion (PLIF)
Posterior lumbar interbody fusion (PLIF)
Other Name: PLIF
Procedure: Extreme lateral interbody fusion (XLIF)
Extreme lateral interbody fusion (XLIF)
Other Name: XLIF

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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, California
Memorial Orthopaedic Surgical Group
Long Beach, California, United States, 90806
University of California, San Diego
San Diego, California, United States, 92103
United States, New York
Slocum Dickson Medical Group
New Hartford, New York, United States, 13413
State University of New York, Upstate Medical University
Syracuse, New York, United States, 13202
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
ClinicalTrials.gov Identifier: NCT00254852     History of Changes
Other Study ID Numbers: CR04-004
Study First Received: November 15, 2005
Last Updated: November 20, 2013
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

Additional relevant MeSH terms:
Constriction, Pathologic
Spondylolisthesis
Intervertebral Disc Degeneration
Pathological Conditions, Anatomical
Spondylolysis
Spondylosis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on August 28, 2014