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SLIP II Registry: Spinal Laminectomy Versus Instrumented Pedicle Screw Fusion

NCT03570801 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 662

Last updated 2025-09-29

No results posted yet for this study

Summary

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.

Conditions

  • Lumbar Spondylolisthesis
  • Grade 1 Spondylolisthesis
  • Lumbar Spinal Stenosis
  • Degenerative Spondylolisthesis

Interventions

OTHER

Expert Panel Review

There is some preliminary evidence suggesting that having a group of spinal experts review x-rays prior to treatment might provide useful information to the patient and the patients' treating physician when trying to make a decision about what type of surgery to perform.

Sponsors & Collaborators

  • Lahey Clinic

    lead OTHER

Principal Investigators

  • Zoher Ghogawala, MD · Lahey Hospital & Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-17
Primary Completion
2028-12-31
Completion
2028-12-31

Countries

  • United States
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03570801 on ClinicalTrials.gov