Evaluation of Radiographic and Patient Outcomes Following Lumbar Spine Fusion Using Demineralized Bone Matrix (DBM) Mixed With Autograft
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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 |
- 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 ]
- 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 |
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| 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 | |
| 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: | January 2, 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 Disk Degeneration Pathological Conditions, Anatomical Spondylolysis |
Spondylosis Spinal Diseases Bone Diseases Musculoskeletal Diseases |
ClinicalTrials.gov processed this record on May 23, 2013