SLIP II Registry: Spinal Laminectomy Versus Instrumented Pedicle Screw Fusion

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

Eligibility

Primary outcome measure(s)

• EuroQol-5 Dimensions (EQ-5D) — 1 year, 2 years, 3 years, 4 years, 5 years
  Quality of life will be assessed through EuroQol 5 Dimensions (EQ-5D) at all time points. Analysis will focus on mean change score as well as the percentage of patients who fail to improve EQ-5D score at each time point. Patients randomized to expert panel review will be compared to those without expert panel review.
• NASS patient satisfaction scale — 1 year, 2 years, 3 years, 4 years, 5 years
  The percentage of patients who achieve NASS patient satisfaction score of 1 or 2 will be compared at each time point between those patients who were randomized to an expert panel review or not.

Trial sites (17)

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