SLIP II Registry: Spinal Laminectomy Versus Instrumented Pedicle Screw Fusion

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.

NCT Number	NCT03570801
Lead Sponsor	Lahey Clinic
Conditions	Lumbar Spondylolisthesis, Grade 1 Spondylolisthesis, Lumbar Spinal Stenosis, Degenerative Spondylolisthesis
Enrollment	662 participants
Start Date	2017-10-17
Primary Completion	2028-12-31 (estimated)
Study Completion	2028-12-31 (estimated)
Updated on ClinicalTrials.gov	2025-09-29