"Is Instrumentation Necessary for "Static" Degenerative Spondylolisthesis"

"Is Instrumentation Necessary for "Static" Degenerative Spondylolisthesis - A Prospective Randomized Clinical Study"

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.

Study Overview

• Status: Withdrawn
• Conditions: Spinal Stenosis; Degenerative Spondylolisthesis
• Intervention / Treatment: Procedure: instrumented spinal fusion with laminectomy; Procedure: non-instrumented spinal fusion with laminectomy

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 Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Procedure: 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.
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Infection	Wound Complications	Expected average of 4 weeks
Rate of Symptomatic Pseudoarthrosis		Up to 2 years
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

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Investigators: Principal Investigator: Joon Y Lee, M.D., University of Pittsburgh Medical Center

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: August 18, 2015
• First Submitted That Met QC Criteria: August 20, 2015
• First Posted (Estimate): August 21, 2015

Study Record Updates

• Last Update Posted (Estimate): December 16, 2015
• Last Update Submitted That Met QC Criteria: December 15, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spondylolysis; Spondylosis; Spinal Stenosis; Spondylolisthesis
• Other Study ID Numbers: PRO15040227