Degenerative Disc Disease Clinical Trial
Official title:
A Single Blind, Multi-Center, Randomized, Prospective Clinical Study Comparing Optecure™ Autograft Extender to Autograft Only in Fusion of the Lumbar Spine
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).
Status | Terminated |
Enrollment | 94 |
Est. completion date | August 2011 |
Est. primary completion date | August 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 21 Years and older |
Eligibility |
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) |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | NeuroSpine Solutions, P.C. | Bristol | Tennessee |
United States | Memorial Orthopaedic Surgical Group | Long Beach | California |
United States | Slocum Dickson Medical Group | New Hartford | New York |
United States | University of California, San Diego | San Diego | California |
United States | State University of New York, Upstate Medical University | Syracuse | New York |
United States | Madigan Army Medical Center | Tacoma | Washington |
Lead Sponsor | Collaborator |
---|---|
Exactech |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No | |
Secondary | Oswestry Disability Index (ODI) completed at each visit | pre-operative, 6-week, 3-month, 6-month, 1-year, 2-year | No | |
Secondary | SF-12 patient health surveys completed at each visit | Pre-operative, 6-week, 3-month, 6-month, 1-year, 2-year | No | |
Secondary | Perceived pain noted on visual analog scales (VAS) at each visit | Pre-operative, 6-week, 3-month, 6-month, 1-year, 2-year | No |
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