Clinical trial NCT00254852: Evaluation of Radiographic and Patient Outcomes Following Lumbar Spine Fusion Using Demineralized Bone Matrix (DBM) Mixed With Autograft
Official title: A Single Blind, Multi-Center, Randomized, Prospective Clinical Study Comparing Optecure™ Autograft Extender to Autograft Only in Fusion of the Lumbar Spine
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Stenosis
Spondylolisthesis
Degenerative Disc Disease
Keywords: Primary lumbar fusion
Demineralized Bone Matrix
DBM
Optecure
Allograft
Autograft
Lumbar fusion
Interbody fusion
Instrumented fusion
Non-instrumented fusion
Exactech
Spinal fusion
Lead sponsor: Exactech
Sponsor class: INDUSTRY
First posted: 2005-11-17
Enrollment: 94
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility 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)

Primary outcomes:
measure: Radiographic evidence of fusion on x-rays taken at each post-op visit
timeFrame: Immediate post-op, 6-week, 3-month, 6-month, 1-year, 2-year
Secondary outcomes:
measure: Oswestry Disability Index (ODI) completed at each visit
timeFrame: pre-operative, 6-week, 3-month, 6-month, 1-year, 2-year
measure: SF-12 patient health surveys completed at each visit
timeFrame: Pre-operative, 6-week, 3-month, 6-month, 1-year, 2-year
measure: Perceived pain noted on visual analog scales (VAS) at each visit
timeFrame: Pre-operative, 6-week, 3-month, 6-month, 1-year, 2-year
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: Memorial Orthopaedic Surgical Group
state: California
city: San Diego
country: United States
facility: University of California, San Diego
state: California
city: New Hartford
country: United States
facility: Slocum Dickson Medical Group
state: New York
city: Syracuse
country: United States
facility: State University of New York, Upstate Medical University
state: New York
city: Bristol
country: United States
facility: NeuroSpine Solutions, P.C.
state: Tennessee
city: Tacoma
country: United States
facility: Madigan Army Medical Center
state: Washington
Study officials:
affiliation: VSAS Orthopedics
name: Amir Fayyazi, MD
role: PRINCIPAL_INVESTIGATOR
References: