Study Stopped
Slow enrollment
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
1 other identifier
interventional
94
1 country
6
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2005
Longer than P75 for not_applicable
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2005
CompletedFirst Submitted
Initial submission to the registry
November 15, 2005
CompletedFirst Posted
Study publicly available on registry
November 17, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2011
CompletedNovember 21, 2013
November 1, 2013
5.8 years
November 15, 2005
November 20, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Radiographic evidence of fusion on x-rays taken at each post-op visit
Immediate post-op, 6-week, 3-month, 6-month, 1-year, 2-year
Secondary Outcomes (3)
Oswestry Disability Index (ODI) completed at each visit
pre-operative, 6-week, 3-month, 6-month, 1-year, 2-year
SF-12 patient health surveys completed at each visit
Pre-operative, 6-week, 3-month, 6-month, 1-year, 2-year
Perceived pain noted on visual analog scales (VAS) at each visit
Pre-operative, 6-week, 3-month, 6-month, 1-year, 2-year
Study Arms (2)
O
ACTIVE COMPARATORThis treatment arm includes autograft harvested from local bone and / or the iliac crest, supplemented with a demineralized bone matrix (DBM) autograft extender, Optecure.
A
ACTIVE COMPARATORThis treatment arm includes autograft harvested from local bone and / or the iliac crest.
Interventions
Posterior lateral fusion (PLF) of the lumbar spine
Anterior lumbar interbody fusion (ALIF)
Transforaminal lumbar interbody fusion (TLIF)
Posterior lumbar interbody fusion (PLIF)
Extreme lateral interbody fusion (XLIF)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Exactechlead
Study Sites (6)
Memorial Orthopaedic Surgical Group
Long Beach, California, 90806, United States
University of California, San Diego
San Diego, California, 92103, United States
Slocum Dickson Medical Group
New Hartford, New York, 13413, United States
State University of New York, Upstate Medical University
Syracuse, New York, 13202, United States
NeuroSpine Solutions, P.C.
Bristol, Tennessee, 37620, United States
Madigan Army Medical Center
Tacoma, Washington, 98431, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Amir Fayyazi, MD
VSAS Orthopedics
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 15, 2005
First Posted
November 17, 2005
Study Start
October 1, 2005
Primary Completion
August 1, 2011
Study Completion
August 1, 2011
Last Updated
November 21, 2013
Record last verified: 2013-11