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SLIP II Registry: Spinal Laminectomy Versus Instrumented Pedicle Screw Fusion (SLIP II)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03570801
Recruitment Status : Recruiting
First Posted : June 27, 2018
Last Update Posted : July 7, 2021
Sponsor:
Information provided by (Responsible Party):
Lahey Clinic

Brief Summary:

The purpose of this registry is two fold. First, to determine the comparative 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. The registry will also determine if an expert panel review of individual patient cases (degenerative grade I spondylolisthesis/stenosis) is associated with improved outcome and patient satisfaction.

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.'

This study aims to prospectively collect comparative data for these patients treated with either decompression alone or decompression with fusion.


Condition or disease Intervention/treatment Phase
Lumbar Spondylolisthesis Grade 1 Spondylolisthesis Lumbar Spinal Stenosis Degenerative Spondylolisthesis Other: Expert Panel Review Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized Control Trial with randomization ratio 1:1
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: SLIP II Registry: Spinal Laminectomy to Laminectomy With Instrumented Pedicle Screw Fusion for Lumbar Stenosis With Grade I Spondylolisthesis
Actual Study Start Date : October 17, 2017
Estimated Primary Completion Date : November 30, 2022
Estimated Study Completion Date : November 30, 2026

Arm Intervention/treatment
Experimental: Expert Panel Review

For 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.

Other: Expert Panel Review
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.

No Intervention: No Expert Panel Review
For 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.



Primary Outcome Measures :
  1. Oswestry Disability Index (ODI) [ Time Frame: Baseline, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years ]
    The percentage of patients who change more than 10 ODI points.


Secondary Outcome Measures :
  1. Patient Satisfaction [ Time Frame: 1 year, 2 years, 3 years, 4 years, 5 years ]
    To determine if an expert panel review of individual patient cases is associated with improved patient satisfaction after surgery, patient satisfaction will be assessed by the Satisfaction Scale adapted from the North American Spine Society. The percentage of patients who report that (1) the treatment met expectations or (2) did not improve as much as hoped, but would undergo the same treatment for the same outcome will be compared to the patients who state that (3) did not improve as much as hoped, and would not undergo the same treatment for the same outcome or (4) am the same or worse than before treatment.

  2. EuroQol-5 Dimensions (EQ-5D) [ Time Frame: Baseline, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years ]
    Quality of life will be assessed through EuroQol 5 Dimensions (EQ-5D) at all time points. The three-level scale denotes no problems, some problems, or extreme problems, across the five domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. A visual analog scale is also used to evaluate overall health state.

  3. Cost Data -- Hospital Claims & Health Resource Utilization [ Time Frame: 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years ]
    Costs will also be compared between groups during the duration of the study.

  4. Complications [ Time Frame: 1 month ]
    Complications at time of surgery to 30 days post-operative will be collected.

  5. Return to Work [ Time Frame: Baseline, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years ]
    Working status will be asked at all time points to capture productivity.

  6. Flexion-Extension Radiographs [ Time Frame: Baseline, 1 year, 2 years ]
    To determine stability after surgery as well as fusion.

  7. 36-inch Standing Plain Radiographs [ Time Frame: Baseline, 1 year ]
    To assess spine alignment.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • Serious medical illness (ASA Class IV or higher)
  • Spondylolysis
  • Multilevel spondylolisthesis or high grade spondylolisthesis (grade II or greater than 14mm)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03570801


Contacts
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Contact: Melissa Dunbar, MPH 781-744-8774 melissa.r.dunbar@lahey.org
Contact: Susan Christopher, RN 781-744-7904 susan.r.christopher@lahey.org

Locations
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United States, Arizona
Barrow Brain and Spine Recruiting
Scottsdale, Arizona, United States, 85251
Contact: Luis Tumialán, MD         
Contact: Marlinda Dygert       mgurule@honorhealth.com   
United States, California
University of California, San Fransisco Recruiting
San Francisco, California, United States, 94143
Contact: Praveen V Mummaneni, MD         
Contact: Vivian Le       Vivian.Le2@ucsf.edu   
United States, Florida
University of Miami Recruiting
Miami, Florida, United States, 33125
Contact: Michael Wang, MD         
Contact: Anabela Cieslicki       axc1623@med.miami.edu   
United States, Illinois
Carle Neurosciences Institute Recruiting
Urbana, Illinois, United States, 61801
Contact: Paul Arnold, MD         
Contact: Courtney Weiss, BSP, ST/MA       Courtney.Weiss@carle.com   
United States, Kentucky
Norton Leatherman Spine Center Recruiting
Louisville, Kentucky, United States, 40202
Contact: Steven D Glassman, MD         
Contact: Morgan Brown, MS       Morgan.brown2@nortonhealthcare.org   
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Jean V. Coumans, MD         
Contact: Akeive Burrows       AJBURROWS@mgh.harvard.edu   
Lahey Hospital & Medical Center Recruiting
Burlington, Massachusetts, United States, 01803
Contact: Zoher Ghogawala, MD    781-744-3180    zoher.ghogawala@lahey.org   
Contact: Melissa Dunbar, MPH    781-744-8774    melissa.r.dunbar@lahey.org   
Sub-Investigator: Subu N Magge, MD         
Sub-Investigator: Robert G Whitmore, MD         
United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: David Polly, MD         
Contact: Tonya Nelson       nel02095@umn.edu   
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55902
Contact: Mohamad Bydon, MD         
Contact: Bradon Trammell       Trammell.Brandon@mayo.edu   
United States, New York
Hospital for Special Surgery Recruiting
New York, New York, United States, 10021
Contact: Todd J Albert, MD         
Contact: Tianna Bennet       bennettt@hss.edu   
Columbia University Recruiting
New York, New York, United States, 10027
Contact: Ronald C Lehman, MD         
Contact: Eric Leung       el2933@cumc.columbia.edu   
Sub-Investigator: Peter D Angevine, MD, MPH         
Sub-Investigator: Paul McCormick, MD, MPH         
United States, Ohio
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Contact: Edward Benzel, MD         
Contact: Emily Fisher       FISHERE3@ccf.org   
United States, Pennsylvania
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Adam S Kanter, MD         
Contact: Jan Alicandro       alicandroja@upmc.edu   
United States, Utah
University of Utah Hospital Recruiting
Salt Lake City, Utah, United States, 84132
Contact: Erica F Bisson, MD, MPH         
Contact: Andrea Strauss       Andrea.Strauss@hsc.utah.edu   
United States, Wisconsin
University of Wisconsin Recruiting
Madison, Wisconsin, United States, 53792
Contact: Daniel K Resnick, MD         
Contact: Stephanie Wilbrand, PhD       wilbrand@neurosurgery.wisc.edu   
Canada, Ontario
University Health Network - Toronto Western Hospital Recruiting
Toronto, Ontario, Canada, M5T 2S8
Contact: Michael G Fehlings, MD, PhD         
Contact: Yuriy Petrenko       Yuriy.Petrenko@uhn.ca   
Sponsors and Collaborators
Lahey Clinic
Investigators
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Principal Investigator: Zoher Ghogawala, MD Lahey Hospital & Medical Center
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Responsible Party: Lahey Clinic
ClinicalTrials.gov Identifier: NCT03570801    
Other Study ID Numbers: 2017-047
First Posted: June 27, 2018    Key Record Dates
Last Update Posted: July 7, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lahey Clinic:
Lumbar Spondylolisthesis
Grade 1 Spondylolisthesis
Lumbar Spinal Stenosis
Degenerative Spondylolisthesis
Additional relevant MeSH terms:
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Spinal Stenosis
Spondylolisthesis
Constriction, Pathologic
Pathological Conditions, Anatomical
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Spondylolysis
Spondylosis