SLIP II Registry: Spinal Laminectomy Versus Instrumented Pedicle Screw Fusion
SLIPII
1 other identifier
interventional
662
2 countries
17
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2017
Longer than P75 for not_applicable
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 17, 2017
CompletedFirst Submitted
Initial submission to the registry
June 12, 2018
CompletedFirst Posted
Study publicly available on registry
June 27, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2028
September 29, 2025
September 1, 2025
11.2 years
June 12, 2018
September 24, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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 Outcomes (8)
Oswestry Disability Index (ODI)
Baseline, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
Oswestry Disability Index (ODI)
Baseline, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
EuroQol-5 Dimensions (EQ-5D)
Baseline, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
Cost Data -- Hospital Claims & Health Resource Utilization
3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
Complications
1 month
- +3 more secondary outcomes
Study Arms (2)
Expert Panel Review
EXPERIMENTALFor patients who are randomized to receive an expert panel review, de-identified lumbar MRI (sagittal and key axial images), 36-inch standing plain radiographs (if available), and flexion and extension radiographs will be uploaded into a web-based platform and reviewed. These will be submitted for an Expert Panel Review. Images will be reviewed through a Spine Expert's Network, consisting of physicians involved in this study who will each offer their opinion as to which of two surgical treatment groups (decompression alone or decompression with fusion) they would choose for the patient. The results of this review will be discussed between the patient and the patient's physician. Together, they will determine the best surgical approach.
No Expert Panel Review
NO INTERVENTIONFor patients not receiving the expert panel review, they will discuss with their surgeon the best surgical option and proceed as they would in standard of care.
Interventions
There is some preliminary evidence suggesting that having a group of spinal experts review x-rays prior to treatment might provide useful information to the patient and the patients' treating physician when trying to make a decision about what type of surgery to perform.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- Serious medical illness (ASA Class IV or higher)
- Spondylolysis
- Multilevel spondylolisthesis or high grade spondylolisthesis (grade II or greater than 14mm)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Lahey Cliniclead
Study Sites (17)
Barrow Brain and Spine
Scottsdale, Arizona, 85251, United States
University of California, San Fransisco
San Francisco, California, 94143, United States
University of Miami
Miami, Florida, 33125, United States
Carle Neurosciences Institute
Urbana, Illinois, 61801, United States
Goodman Campbell Brain & Spine
Carmel, Indiana, 46032, United States
Norton Leatherman Spine Center
Louisville, Kentucky, 40202, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Lahey Hospital & Medical Center
Burlington, Massachusetts, 01803, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Mayo Clinic
Rochester, Minnesota, 55902, United States
Hospital for Special Surgery
New York, New York, 10021, United States
Columbia University
New York, New York, 10027, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
University of Utah Hospital
Salt Lake City, Utah, 84132, United States
University of Wisconsin
Madison, Wisconsin, 53792, United States
University Health Network - Toronto Western Hospital
Toronto, Ontario, M5T 2S8, Canada
Related Publications (1)
Ghogawala Z, Rizvi TZ, Lin Z, Kanter A, Mummaneni PV, Bisson EF, Albert TJ, Resnick DK, Wang MY, Glassman S, Polly DW Jr, Bydon M, Magge SN, Tumialan LM, Fehlings MG, Steinmetz MP, Whitmore RG, Rajshekhar V, Harrop JS, Hartl R, Ahmed E, Coric D, McCormick PC, Assaker R, Msaddi AK, Holly LT, Kawaguchi Y, Falavigna A, Barker FG 2nd, Benzel EC; SLIP II Investigators. Use of an Expert Panel for Symptomatic Patients With Grade I Degenerative Lumbar Spondylolisthesis: A Randomized Clinical Trial. Neurosurgery. 2025 Nov 6. doi: 10.1227/neu.0000000000003838. Online ahead of print.
PMID: 41196064DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zoher Ghogawala, MD
Lahey Hospital & Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 12, 2018
First Posted
June 27, 2018
Study Start
October 17, 2017
Primary Completion (Estimated)
December 31, 2028
Study Completion (Estimated)
December 31, 2028
Last Updated
September 29, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- After primary analysis has been published for up to 5 years.
Deidentified data would be shared with other researchers after primary analysis has been published.