"Is Instrumentation Necessary for "Static" Degenerative Spondylolisthesis"
NCT ID: NCT02530775
Last Updated: 2015-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2015-10-31
2015-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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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.
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.
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.
non-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.
Interventions
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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.
non-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.
Eligibility Criteria
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Inclusion Criteria
2. Patients with concomitant spinal stenosis.
3. Laminectomy at any lumbar levels of stenosis.
4. Fusion only at L4-5 level.
Exclusion Criteria
2. Multi-level spondylolisthesis
3. Anterior interbody work/fusion
4. Tumor
5. Infection
6. Trauma
18 Years
ALL
No
Sponsors
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University of Pittsburgh
OTHER
Responsible Party
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Joon Yung Lee, MD
M.D.
Principal Investigators
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Joon Y Lee, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh Medical Center
Other Identifiers
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PRO15040227
Identifier Type: -
Identifier Source: org_study_id