Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

ACTIVE NOT RECRUITING NA

SLIP II Registry: Spinal Laminectomy Versus Instrumented Pedicle Screw Fusion

NCT03570801 · View on ClinicalTrials.gov ↗

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.

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

17 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03570801

The ClinicalTrials.gov registry entry for NCT03570801 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 662 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Lahey Clinic, which has 17 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03570801 reports 17 study locations spanning 14 distinct geographic areas — top geographies include Massachusetts, Minnesota, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03570801?

The interventions under investigation include: Expert Panel Review (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03570801?

This trial is sponsored by Lahey Clinic, which has 17 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial