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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 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.

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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.

Conditions Studied

Lumbar Spinal Stenosis Degenerative Spondylolisthesis Lumbar Spondylolisthesis Grade 1 Spondylolisthesis

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

FieldValue
Enrollment Target 662 participants
Start Date 2017-10-17
Est. Completion 2028-12-31
Phase NA

Sponsor

Lahey Clinic

43 total trials

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What the Registry Record Tells You About NCT03570801

The ClinicalTrials.gov registry entry for NCT03570801 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 662 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 633-participant average among 18 other Lumbar Spinal Stenosis trials with a reported enrollment target. The listed sponsor is Lahey Clinic, which has 43 total studies on file at ClinicalTrials.gov.

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 reports 17 study locations spanning 14 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.