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The study did not receive IRB approval and was withdrawn
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| instrumented arthrodesis | Active Comparator | 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. |
|
| non-instrumented arthrodesis | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| instrumented spinal fusion with laminectomy | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Functional Outcome Scores: SF-12/SF-36 Quality of Life Questionnaires | 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) | Up to 2 years |
| Functional Outcome Scores: Oswestry Disability Index (ODI) Questionnaire | Measured by patient outcome survey such as the Oswestry Disability Index (ODI) that assesses low back pain (scoring ranges from 0 to >35) | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Infection | Wound Complications | Expected average of 4 weeks |
| Rate of Symptomatic Pseudoarthrosis | Up to 2 years | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joon Y Lee, M.D. | University of Pittsburgh Medical Center | Principal Investigator |
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| ID | Term |
|---|---|
| D013130 | Spinal Stenosis |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D007796 | Laminectomy |
| ID | Term |
|---|---|
| D019637 | Orthopedic Procedures |
| D013812 | Therapeutics |
| D019299 | Decompression, Surgical |
| D013514 | Surgical Procedures, Operative |
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| non-instrumented spinal fusion with laminectomy | Procedure | 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. |
|
| Need for Revision Surgery |
Return to the OR |
| Up to 2 years |
| Length of Hospital Stay | Expected average of 1 week |
| Surgical Time | 2-4 hours |
| D019635 | Neurosurgical Procedures |