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NCT03570801
SLIP II Registry: Spinal Laminectomy Versus Instrumented Pedicle Screw Fusion
Conditions: Lumbar Spondylolisthesis, Grade 1 Spondylolisthesis, Lumbar Spinal Stenosis, Degenerative Spondylolisthesis
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 662
Sponsor: Lahey Clinic
Location: Barrow Brain and Spine Scottsdale Arizona
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 Criteria
Inclusion Criteria:
* 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)
Exclusion Criteria:
* Serious medical illness (ASA Class IV or higher)
* Spondylolysis
* Multilevel spondylolisthesis or high grade spondylolisthesis (grade II or greater than 14mm)
Source: ClinicalTrials.gov (NCT03570801). StuddyBuddy aggregates publicly available trial information.