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Laminectomy vs Fusion for Lumbar Spinal Stenosis (SLIPII Trial)

Louisville, KY

N/A

Waitlist Available

Led By Zoher Ghogawala, MD

Research Sponsored by Lahey Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Symptomatic lumbar spinal stenosis: defined as radicular and/or back pain either induced or aggravated by activity and relieved by rest

Single-level grade I degenerative spondylolisthesis (3-14mm)

Must not have

Spondylolysis

Multilevel spondylolisthesis or high grade spondylolisthesis (grade II or greater than 14mm)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year, 2 years, 3 years, 4 years, 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to compare patient satisfaction and outcomes with or without the use of an expert panel for patients with degenerative grade I spondylolisthesis and symptomatic lumbar spinal stenosis

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Who is the study for?

This trial is for individuals with symptomatic lumbar spinal stenosis and single-level grade I degenerative spondylolisthesis. Participants should experience back or leg pain that worsens with activity and improves with rest.Check my eligibility

What is being tested?

The study compares patient satisfaction between those who receive advice from an expert panel versus those who don't, in the treatment of spinal conditions. It also evaluates the effectiveness of decompression alone versus decompression plus fusion surgery.See study design

What are the potential side effects?

While specific side effects are not detailed, surgical interventions may include risks such as infection, bleeding, nerve damage, or need for additional surgeries. Patient experiences can vary based on individual health factors.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have back pain that worsens with activity and eases with rest.

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I have a mild slipped disc in my spine.

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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a crack or stress fracture in my spine.

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My spine condition involves slipped vertebrae of a severe degree.

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I have a severe health condition.

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Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year, 2 years, 3 years, 4 years, 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year, 2 years, 3 years, 4 years, 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year, 2 years, 3 years, 4 years, 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

NASS patient satisfaction scale

Secondary study objectives

36-inch Standing Plain Radiographs

Complications

Cost Data -- Hospital Claims & Health Resource Utilization

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Expert Panel ReviewExperimental Treatment1 Intervention

For patients who are randomized to receive an expert panel review, de-identified lumbar MRI (sagittal and key axial images), 36-inch standing plain radiographs (if available), and flexion and extension radiographs will be uploaded into a web-based platform and reviewed. These will be submitted for an Expert Panel Review. Images will be reviewed through a Spine Expert's Network, consisting of physicians involved in this study who will each offer their opinion as to which of two surgical treatment groups (decompression alone or decompression with fusion) they would choose for the patient. The results of this review will be discussed between the patient and the patient's physician. Together, they will determine the best surgical approach.

Group II: No Expert Panel ReviewActive Control1 Intervention

For patients not receiving the expert panel review, they will discuss with their surgeon the best surgical option and proceed as they would in standard of care.

0 / 5Eligibility criteria met