SLIP II Registry: Spinal Laminectomy Versus Instrumented Pedicle Screw Fusion

Running, not enrolling · Not applicable

Conditions studied: Lumbar Spondylolisthesis, Grade 1 Spondylolisthesis, Lumbar Spinal Stenosis, Degenerative Spondylolisthesis

In brief

The purpose of the project is to perform an RCT comparing patient satisfaction and outcome with or without the use of an expert panel. The purpose is also to create a registry to compare the effectiveness of decompression alone versus decompression with fusion for patients with degenerative grade I spondylolisthesis and symptomatic lumbar spinal stenosis. Primary analysis will focus on the patients' improvement from baseline patient-reported outcome questionnaires. In addition, the SLIP II registry aims to (i) develop an algorithm which could identify cases in which surgical experts are likely to recommend one treatment (i.e. \>80% of experts recommend one form of treatment) and (ii) develop a radiology-based machine learning algorithm that would prospectively classify patients as either 'stable' or 'unstable.' In addition to patient reported outcomes, step counts will be collected in order to determine the correlation of step count with patient-reported outcomes (ODI and EQ-5D) and the need for re-operation. This registry portion of the study aims to prospectively collect comparative data for these patients treated with either decompression alone or decompression with fusion.

Key facts

Study ID

NCT03570801

Run by

Lahey Clinic

People needed

662

Starts

2017-10-17

Expected to finish

2028-12-31

Last updated by the study team

2025-09-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• Serious medical illness (ASA Class IV or higher)
• Spondylolysis
• Multilevel spondylolisthesis or high grade spondylolisthesis (grade II or greater than 14mm)

Where it is running

• Barrow Brain and Spine — Scottsdale, Arizona, United States
• University of California, San Fransisco — San Francisco, California, United States
• University of Miami — Miami, Florida, United States
• Carle Neurosciences Institute — Urbana, Illinois, United States
• Goodman Campbell Brain & Spine — Carmel, Indiana, United States
• Norton Leatherman Spine Center — Louisville, Kentucky, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Lahey Hospital & Medical Center — Burlington, Massachusetts, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Hospital for Special Surgery — New York, New York, United States
• Columbia University — New York, New York, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States
• University of Utah Hospital — Salt Lake City, Utah, United States
• University of Wisconsin — Madison, Wisconsin, United States
• University Health Network - Toronto Western Hospital — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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