"Is Instrumentation Necessary for "Static" Degenerative Spondylolisthesis"

Not Applicable

Withdrawn

• Conditions: Degenerative Spondylolisthesis; Spinal Stenosis
• Interventions: Procedure: instrumented spinal fusion with laminectomy; Procedure: non-instrumented spinal fusion with laminectomy

• Registration Number: NCT02530775
• Lead Sponsor: University of Pittsburgh

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 Timeline

• Study First Submitted: 2015-08-18
• Study First Submitted QC: 2015-08-20
• Study First Posted: 2015-08-21
• Study Start: 2015-10
• Status Verified: 2015-12
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Last Update Submitted: 2015-12-15
• Last Update Posted: 2015-12-16

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

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Exclusion Criteria

1. Prior lumbar spine surgery
2. Multi-level spondylolisthesis
3. Anterior interbody work/fusion
4. Tumor
5. Infection
6. Trauma

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
instrumented arthrodesis	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 with use of instrumentation and lumbar laminectomy. No additional "drug" or "device" intervention.
non-instrumented arthrodesis	non-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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Rate of Infection	Expected average of 4 weeks	Wound Complications
Rate of Symptomatic Pseudoarthrosis	Up to 2 years
Need for Revision Surgery	Up to 2 years	Return to the OR
Length of Hospital Stay	Expected average of 1 week
Surgical Time	2-4 hours