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Active, not recruiting Not applicable Interventional

SLIP II Registry: Spinal Laminectomy Versus Instrumented Pedicle Screw Fusion

ClinicalTrials.gov ID: NCT03570801

Public ClinicalTrials.gov record NCT03570801. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 5, 2026, 4:18 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

SLIP II Registry: Spinal Laminectomy to Laminectomy With Instrumented Pedicle Screw Fusion for Lumbar Stenosis With Grade I Spondylolisthesis

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT03570801
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Not applicable
Lead sponsor
Lahey Clinic
Other
Enrollment
662 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Oct 16, 2017
Primary completion
Dec 30, 2028
Completion
Dec 30, 2028
Last update posted
Sep 28, 2025

2017 – 2028

United States locations

U.S. sites
16
U.S. states
13
U.S. cities
15
Facility City State ZIP Site status
Barrow Brain and Spine Scottsdale Arizona 85251
University of California, San Fransisco San Francisco California 94143
University of Miami Miami Florida 33125
Carle Neurosciences Institute Urbana Illinois 61801
Goodman Campbell Brain & Spine Carmel Indiana 46032
Norton Leatherman Spine Center Louisville Kentucky 40202
Massachusetts General Hospital Boston Massachusetts 02114
Lahey Hospital & Medical Center Burlington Massachusetts 01803
University of Minnesota Minneapolis Minnesota 55455
Mayo Clinic Rochester Minnesota 55902
Hospital for Special Surgery New York New York 10021
Columbia University New York New York 10027
Cleveland Clinic Foundation Cleveland Ohio 44195
University of Pittsburgh Pittsburgh Pennsylvania 15213
University of Utah Hospital Salt Lake City Utah 84132
University of Wisconsin Madison Wisconsin 53792

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03570801, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 28, 2025 · Synced Sep 5, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03570801 live on ClinicalTrials.gov.

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