SLIP II Registry: Spinal Laminectomy Versus Instrumented Pedicle Screw Fusion (SLIP II)
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|ClinicalTrials.gov Identifier: NCT03570801|
Recruitment Status : Recruiting
First Posted : June 27, 2018
Last Update Posted : July 7, 2021
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1000 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized Control Trial with randomization ratio 1:1|
|Masking:||None (Open Label)|
|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|
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.
- 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.
- 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.
- 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.
- 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.
- Complications [ Time Frame: 1 month ]Complications at time of surgery to 30 days post-operative will be collected.
- 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.
- Flexion-Extension Radiographs [ Time Frame: Baseline, 1 year, 2 years ]To determine stability after surgery as well as fusion.
- 36-inch Standing Plain Radiographs [ Time Frame: Baseline, 1 year ]To assess spine alignment.
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
|Contact: Melissa Dunbar, MPHemail@example.com|
|Contact: Susan Christopher, RNfirstname.lastname@example.org|
|United States, Arizona|
|Barrow Brain and Spine||Recruiting|
|Scottsdale, Arizona, United States, 85251|
|Contact: Luis Tumialán, MD|
|Contact: Marlinda Dygert email@example.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 firstname.lastname@example.org|
|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.email@example.com|
|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 firstname.lastname@example.org|
|Contact: Melissa Dunbar, MPH 781-744-8774 email@example.com|
|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 firstname.lastname@example.org|
|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 email@example.com|
|New York, New York, United States, 10027|
|Contact: Ronald C Lehman, MD|
|Contact: Eric Leung firstname.lastname@example.org|
|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 email@example.com|
|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 firstname.lastname@example.org|
|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|
|Principal Investigator:||Zoher Ghogawala, MD||Lahey Hospital & Medical Center|