Lumbar Spinal Stenosis Clinical Trial
— SLIPIIOfficial title:
SLIP II Registry: Spinal Laminectomy to Laminectomy With Instrumented Pedicle Screw Fusion for Lumbar Stenosis With Grade I Spondylolisthesis
Verified date | May 2024 |
Source | Lahey Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 662 |
Est. completion date | March 5, 2024 |
Est. primary completion date | March 8, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
Canada | University Health Network - Toronto Western Hospital | Toronto | Ontario |
United States | Massachusetts General Hospital | Boston | Massachusetts |
United States | Lahey Hospital & Medical Center | Burlington | Massachusetts |
United States | Goodman Campbell Brain & Spine | Carmel | Indiana |
United States | Cleveland Clinic Foundation | Cleveland | Ohio |
United States | Norton Leatherman Spine Center | Louisville | Kentucky |
United States | University of Wisconsin | Madison | Wisconsin |
United States | University of Miami | Miami | Florida |
United States | University of Minnesota | Minneapolis | Minnesota |
United States | Columbia University | New York | New York |
United States | Hospital for Special Surgery | New York | New York |
United States | University of Pittsburgh | Pittsburgh | Pennsylvania |
United States | Mayo Clinic | Rochester | Minnesota |
United States | University of Utah Hospital | Salt Lake City | Utah |
United States | University of California, San Fransisco | San Francisco | California |
United States | Barrow Brain and Spine | Scottsdale | Arizona |
United States | Carle Neurosciences Institute | Urbana | Illinois |
Lead Sponsor | Collaborator |
---|---|
Lahey Clinic |
United States, Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | EuroQol-5 Dimensions (EQ-5D) | 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. | 1 year, 2 years, 3 years, 4 years, 5 years | |
Primary | NASS patient satisfaction scale | 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. | 1 year, 2 years, 3 years, 4 years, 5 years | |
Secondary | Oswestry Disability Index (ODI) | To determine at 1 and 2 years if an expert panel review of individual cases is associated with a greater percentage of patients who improve by more than 10 points. In addition, we will compare mean change in ODI score among patients randomized to expert panel review to those randomized to receive no review. | Baseline, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years | |
Secondary | Oswestry Disability Index (ODI) | To compare mean change in ODI score between patients treated with laminectomy alone versus laminectomy with instrumented lumbar fusion | Baseline, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years | |
Secondary | EuroQol-5 Dimensions (EQ-5D) | Quality of life will be assessed through EuroQol 5 Dimensions (EQ-5D) at all time points. The three-level scale denotes no problems, some problems, or extreme problems, across the five domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. A visual analog scale is also used to evaluate overall health state. Comparisons among groups will compare difference in the change scores. | Baseline, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years | |
Secondary | Cost Data -- Hospital Claims & Health Resource Utilization | Costs will also be compared between groups during the duration of the study. | 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years | |
Secondary | Complications | Complications at time of surgery to 30 days post-operative will be collected. | 1 month | |
Secondary | Return to Work | Working status will be asked at all time points to capture productivity. | Baseline, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years | |
Secondary | Flexion-Extension Radiographs | To determine stability after surgery as well as fusion. | Baseline, 1 year, 2 years | |
Secondary | 36-inch Standing Plain Radiographs | To assess spine alignment. | Baseline, 1 year |
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