"Is Instrumentation Necessary for "Static" Degenerative Spondylolisthesis - A Prospective Randomized Clinical Study"
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- University of Pittsburgh
- Primary Endpoint
- Functional Outcome Scores: SF-12/SF-36 Quality of Life Questionnaires
Study Overview
Brief Summary
The purpose of this study is to determine whether instrumented lumbar fusion provides superior clinical outcomes in comparison to non-instrumented fusion in patients with "static" degenerative spondylolisthesis.
Detailed Description
This study will determine whether instrumented lumbar fusion will provide superior clinical outcomes in comparison to non-instrumented fusion in patients with "STATIC" degenerative spondylolisthesis. At the time of scheduling surgery, patients who meet the inclusion/exclusion criteria will be asked to participate. Patients who agree, will be randomized to either non-instrumented or instrumented arthrodesis group. Intra-operative, peri-operative, and post-operative data will be collected and compared. The investigators predict to get very similar clinical outcomes between the two groups, with possibly less complications from the non-instrumented group and definitely a reduction in cost compared to the instrumented group.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with stable L4-5 spondylolisthesis on lumbar flexion and extension radiographs. Stability will be determined by the treating physician.
- •Patients with concomitant spinal stenosis.
- •Laminectomy at any lumbar levels of stenosis.
- •Fusion only at L4-5 level.
Exclusion Criteria
- •Prior lumbar spine surgery
- •Multi-level spondylolisthesis
- •Anterior interbody work/fusion
Arms & Interventions
instrumented arthrodesis
Degenerative Spondylolisthesis and Spinal Stenosis patients having a surgical procedure. The surgical procedure is the intervention and is a spinal fusion with use of instrumentation and lumbar laminectomy. No additional "drug" or "device" intervention.
Intervention: instrumented spinal fusion with laminectomy (Procedure)
non-instrumented arthrodesis
Degenerative Spondylolisthesis and Spinal Stenosis patients having a surgical procedure. The surgical procedure is the intervention and is a spinal fusion without the use of instrumentation and lumbar laminectomy. No additional "drug" or "device" intervention.
Intervention: non-instrumented spinal fusion with laminectomy (Procedure)
Outcomes
Primary Outcomes
Functional Outcome Scores: SF-12/SF-36 Quality of Life Questionnaires
Time Frame: Up to 2 years
Measured by patient outcome survey such as the SF-12 or SF-36 Questionnaire (all questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning possible)
Functional Outcome Scores: Oswestry Disability Index (ODI) Questionnaire
Time Frame: Up to 2 years
Measured by patient outcome survey such as the Oswestry Disability Index (ODI) that assesses low back pain (scoring ranges from 0 to \>35)
Secondary Outcomes
- Length of Hospital Stay(Expected average of 1 week)
- Surgical Time(2-4 hours)
- Rate of Infection(Expected average of 4 weeks)
- Rate of Symptomatic Pseudoarthrosis(Up to 2 years)
- Need for Revision Surgery(Up to 2 years)
Investigators
Joon Yung Lee, MD
M.D.
University of Pittsburgh