Degenerative Spondylolisthesis, Spinal Stenosis
Conditions
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.
Interventions
PROCEDUREinstrumented spinal fusion with laminectomy
Once determined that a patient has single level static degenerative spondylolisthesis and is planning to schedule surgery the patient will be approached by a research team member explaining the study and reviewing the informed consent document. If the patient chooses to participate, he or she will be randomized to be apart of the non-instrumented arthrodesis with laminectomy group or the instrumented arthrodesis with laminectomy group. Both are standard approved surgical approaches; however, using instrumentation is the more commonly used approach.
PROCEDUREnon-instrumented spinal fusion with laminectomy
Once determined that a patient has single level static degenerative spondylolisthesis and is planning to schedule surgery the patient will be approached by a research team member explaining the study and reviewing the informed consent document. If the patient chooses to participate, he or she will be randomized to be apart of the non-instrumented arthrodesis with laminectomy group or the instrumented arthrodesis with laminectomy group. Both are standard approved surgical approaches; however, using instrumentation is the more commonly used approach.
Sponsors
University of Pittsburgh
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients with stable L4-5 spondylolisthesis on lumbar flexion and extension radiographs. Stability will be determined by the treating physician. 2. Patients with concomitant spinal stenosis. 3. Laminectomy at any lumbar levels of stenosis. 4. Fusion only at L4-5 level.
Exclusion criteria
1. Prior lumbar spine surgery 2. Multi-level spondylolisthesis 3. Anterior interbody work/fusion 4. Tumor 5. Infection 6. Trauma
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional Outcome Scores: SF-12/SF-36 Quality of Life Questionnaires | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Need for Revision Surgery | Up to 2 years | Return to the OR |
| Rate of Infection | Expected average of 4 weeks | Wound Complications |
| Surgical Time | 2-4 hours | — |
| Length of Hospital Stay | Expected average of 1 week | — |
| Rate of Symptomatic Pseudoarthrosis | Up to 2 years | — |
Outcome results
None listed