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NCT03570801 · ClinicalTrials.gov registry record · NA
SLIP II Registry: Spinal Laminectomy Versus Instrumented Pedicle Screw Fusion
A NA study of Lumbar Spinal Stenosis and Degenerative Spondylolisthesis, sponsored by Lahey Clinic.
- Active
- Registry status
- NA
- Development phase
- 662
- Enrollment target
- 17
- Study locations
NCT03570801: Active NA study of Lumbar Spinal Stenosis and Degenerative Spondylolisthesis, sponsored by Lahey Clinic.
NCT03570801 is a NA study of Lumbar Spinal Stenosis and Degenerative Spondylolisthesis that is active but no longer recruiting, run by Lahey Clinic. The registered enrollment target is 662 participants, roughly in line with the 633-participant average among 18 other Lumbar Spinal Stenosis trials with a reported enrollment target. The trial reports 17 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03570801, a NA study of Lumbar Spinal Stenosis and Degenerative Spondylolisthesis, is active but no longer recruiting, sponsored by Lahey Clinic.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 662 participants
- Enrollment target
- 17
- Study locations
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.
Primary Outcome
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.
Conditions Studied
Interventions
- OTHER Expert Panel Review
Study Locations (17)
Massachusetts
- Massachusetts General Hospital - Boston
- Lahey Hospital & Medical Center - Burlington
Minnesota
- University of Minnesota - Minneapolis
- Mayo Clinic - Rochester
New York
- Hospital for Special Surgery - New York
- Columbia University - New York
Arizona
- Barrow Brain and Spine - Scottsdale
California
- University of California, San Fransisco - San Francisco
Florida
- University of Miami - Miami
Illinois
- Carle Neurosciences Institute - Urbana
Indiana
- Goodman Campbell Brain & Spine - Carmel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 662 participants |
| Start Date | 2017-10-17 |
| Est. Completion | 2028-12-31 |
| Phase | NA |
What the registry record for NCT03570801 still lists
NCT03570801 is an interventional study that assigns participants to a tested intervention. The registered 662 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 633-participant average among 18 other Lumbar Spinal Stenosis trials with a reported enrollment target.
The record links to 4 conditions, with Lumbar Spinal Stenosis appearing as the primary indexed condition, and to 1 intervention - of which Expert Panel Review is the first listed.
NCT03570801 lists 17 locations in 14 states (Massachusetts, Minnesota, New York).
Frequently Asked Questions
What is clinical trial NCT03570801 about?
NCT03570801 is a clinical study titled "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 ...
What is the current status of trial NCT03570801?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 662 participants. The study started on 2017-10-17. Estimated completion is 2028-12-31.
What conditions does trial NCT03570801 study?
This clinical trial studies the following conditions: Lumbar Spinal Stenosis, Degenerative Spondylolisthesis, Lumbar Spondylolisthesis, Grade 1 Spondylolisthesis.
What interventions are being tested in trial NCT03570801?
The interventions under investigation include: Expert Panel Review (OTHER).
Who is sponsoring clinical trial NCT03570801?
This trial is sponsored by Lahey Clinic, which has 43 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03570801 being conducted?
This trial has 17 study locations across Arizona, California, Florida, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03570801's enrollment target sits among peer trials
662 3rd of 18 higher than 16 of 18 other Lumbar Spinal Stenosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Lumbar Spinal Stenosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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