An interventional study of instrumented spinal fusion with laminectomy and non-instrumented spinal fusion with laminectomy in Degenerative Spondylolisthesis and Spinal Stenosis, sponsored by University of Pittsburgh. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-12-16.
Sponsored by University of Pittsburgh · Not applicable, Interventional, and Treatment
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.
459 studies on the registry are indexed under Spinal Stenosis; 103 are open to participants now.
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Exclusion Criteria:
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.
Procedure: instrumented spinal fusion with laminectomy
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.
Procedure: 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.
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.
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)
Time frame: 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)
Time frame: Up to 2 years
Rate of Infection
Wound Complications
Time frame: Expected average of 4 weeks
Rate of Symptomatic Pseudoarthrosis
Time frame: Up to 2 years
Need for Revision Surgery
Return to the OR
Time frame: Up to 2 years
Length of Hospital Stay
Time frame: Expected average of 1 week
Surgical Time
Time frame: 2-4 hours
No study locations are listed for this record.
This study is withdrawn, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.
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