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

• ClinicalTrials.gov Identifier: NCT03570801
• Recruitment Status: Recruiting
• First Posted: June 27, 2018
• Last Update Posted: March 4, 2022
• Sponsor: Lahey Clinic
• Information provided by (Responsible Party): Lahey Clinic

Study Description

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.'

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 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

Detailed Description:

Aim: To conduct a randomized control trial comparing patient outcomes and satisfaction with or without expert panel review before making a final decision about surgery for grade I degenerative lumbar spondylolisthesis. A prospective, multi-center registry aimed at addressing important issues pertaining to outcomes from treatment for degenerative spondylolisthesis and spinal stenosis will be generated.

Background: Surgery may be offered to patients with symptomatic lumbar stenosis with degenerative lumbar spondylolisthesis who fail nonoperative treatment measures including physical therapy and epidural steroid injections. For patients with lumbar stenosis without spondylolisthesis, a decompression alone is typical, while those patients who do have degenerative spondylolisthesis and who also have significant mechanical back pain may be offered lumbar decompression with or without fusion. These guidelines were written based upon the SPORT study, which provided the highest quality of evidence available at the time. Additional studies have show that costly interventions such as lumbar fusion may ultimately be cost-effective if they provide durable clinical benefit. Two recent publications in The New England Journal of Medicine present new evidence with conflicting results on superficial review. The Spinal Laminectomy versus Instrumented Pedicle Screw (SLIP) trial provides level I evidence for the efficacy of fusion to improve clinical outcomes and lower reoperation rates compared to a standard laminectomy and medial facetectomy over a four year time frame in patients with neurogenic claudication associated with stable single level spondylolisthesis. Conversely, the Swedish study provides level II evidence that the addition of a variety of fusion techniques does not have significant benefit in the first two years following operation compared to a variety of decompression techniques in a heterogeneous population of patients with stenosis associated with spondylolisthesis. The patient populations treated, surgical techniques used, and outcome measures assessed differed between the two studies and when taken together, underline the need to new comparative effectiveness data for patients with this problem.

Additionally, one key challenge surgeons face is whether or not to recommend a spinal fusion. Spinal fusion is expensive, assoicated with greater costs and complications, but it appears to be necessary in at least 30% of patients.3 Preliminary data suggests that when when greater than 80% of an expert panel votes for one treatment opition, either a fusion or decompression alone, and when a patient's actual treatment aligns with the expert panel recommention, the patient-reported outcomes are greater than when the surgical approach is not aligned with the expert panel.10 This data highlights an interest in developing articifical intelligence (AI) that may be able to aid in both identification and predictive tasks. Any progress in this realm would be enormously powerful from a clinical standpoint and would likely result in more efficient use of surgical appraoches and in turn, healthcare spending.

All images that are captured in the registry will be used to train convolutional neural networks (CNN). These are mathematical operations which extract patterns from image data and generalize it across many images fed into the dataset. They primarily use calculations to extract patterns which are stored as a model which will be a collection of numbers. The images stored in this registry will be used to develop algorithms to assess cases in which an expert panel is more likely to suggest one treatment over the other as well as develop an algorithm that would prospectively classify patients as either 'stable' or 'unstable.'

Plan: Before making a decision regarding which specific operation should be performed in each case, each patient will be randomized to receive an expert panel review or to not receive an expert panel review. For patients who receive an expert panel review, the patients' 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 with plans to share the reviews with patients and their treating physicians in real time. For patients who are randomized to no expert panel review, they will discuss with their surgeon the best surgical option for them and proceed as they would in standard of care. Patients with symptomatic lumbar spinal stenosis and single level degenerative grade I spondylolisthesis will be treated either with decompression or decompression with fusion. Symptomatic spinal stenosis will be defined as radicular and/or back pain either induced by or aggravated by activity and relieved by rest in a patient with either moderately severe or severe lumbar spinal stenosis. Patient-reported outcomes will be captured at baseline, at 3 and 6 months, and annually out to five years.

The imaging data will be used to create artificial intelligence (AI) algorithms that will help assess when an expert panel is more likely to suggest one treatment over the other as well as develop an algorithm that would prospectively classify patients as either 'stable' or 'unstable.' Ultimately long term follow-up will help confirm whether a case was correctly assessed as stable or unstable. A patient would be confirmed as unstable, if they underwent decompression alone and then required a re-operation to stabilize the spine at the level of spondylolisthesis within 5 years of the initial operation. In a similar way, a patient would be confirmed as stable, if no re-operation were necessary over the 5-year study follow-up period.

Select sites will participate in an assessment of the utilization of step count as an outcome. Average step count will be captured pre-operatively as well as at 3- and 6-months and annually out to 5 years. The mean step count at each time point will be compared to the mean change scores for ODI and EQ-5D. Additionally, average step counts overtime will be analyzed for those patients who undergo a re-operation.

Interim Analysis: An interim analysis is planned when 150 patients have reached eligibility at 6 month follow-up. Patients' change from baseline patient-reported outcome questionnaires will be assessed.

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

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.
8. Step Count [ Time Frame: Baseline, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years ]
   Step count will also be evaluated against outcomes (ODI and EQ-5D) and re-operations.

Eligibility Criteria

• 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)

Contacts and Locations

Contacts

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

United States, Arizona

Barrow Brain and Spine; Recruiting

Scottsdale, Arizona, United States, 85251

Contact: Marlinda Dygert mgurule@honorhealth.com

Contact: Randy Bravo rbravo@honorhealth.com

Principal Investigator: Luis Tumialán, MD

Sub-Investigator: Rory Kenneth John Murphy, MD

Sub-Investigator: Bryan Lee, MD

Sub-Investigator: Frederick M Marciano, MD

United States, California

University of California, San Fransisco; Recruiting

San Francisco, California, United States, 94143

Contact: Vivian Le Vivian.Le2@ucsf.edu

Contact: Alma Rechav Ben-Natan alma.rechavbennatan@ucsf.edu

Principal Investigator: Praveen V Mummaneni, MD

Sub-Investigator: Sigurd Berven, MD

Sub-Investigator: Dean Chou, MD

Sub-Investigator: Aaron Clark, MD

Sub-Investigator: Lee A Tan, MD

United States, Florida

University of Miami; Recruiting

Miami, Florida, United States, 33125

Contact: Anabela Cieslicki axc1623@med.miami.edu

Contact: Miguel Bandes mab816@med.miami.edu

Principal Investigator: Michael Wang, MD

Sub-Investigator: Allan D Levi, MD, PhD, FACS, FAANS

United States, Illinois

Carle Neurosciences Institute; Recruiting

Urbana, Illinois, United States, 61801

Contact: Carly Skadden, MPH, CCRP Carly.Skadden@carle.com

Principal Investigator: Paul Arnold, MD

Sub-Investigator: Kevin Teal, MD

Sub-Investigator: William Olivero, MD

United States, Indiana

Goodman Campbell Brain & Spine; Recruiting

Carmel, Indiana, United States, 46032

Contact: Erin Delaney edelaney@goodmancampbell.com

Contact: Healther Cero hcero@goodmancampbell.com

Principal Investigator: Eric Potts, MD

Sub-Investigator: John J DePowell, MD

Sub-Investigator: Eric Horn, MD

Sub-Investigator: Saad Khairi, MD

Sub-Investigator: Charles Kulwin, MD

Sub-Investigator: Shannon McCanna, MD, FAANS

Sub-Investigator: John-Pierre Mobasser, MD

Sub-Investigator: Richard Rogers, MD

United States, Kentucky

Norton Leatherman Spine Center; Recruiting

Louisville, Kentucky, United States, 40202

Contact: Morgan Brown, MS Morgan.brown2@nortonhealthcare.org

Contact: Christy Daniels, MRC christy.daniels@nortonhealthcare.org

Principal Investigator: Steven D Glassman, MD

Sub-Investigator: Charles H Crawford III, MD

Sub-Investigator: John R Dimar II, MD

Sub-Investigator: Mladen Djurasovic, MD

Sub-Investigator: Jeffrey Gum, MD

United States, Massachusetts

Massachusetts General Hospital; Recruiting

Boston, Massachusetts, United States, 02114

Contact: Akeive Burrows AJBURROWS@mgh.harvard.edu

Principal Investigator: Jean J Coumans, MD

Sub-Investigator: John Shin, MD

Sub-Investigator: Ganesh Shankar, MD

Lahey Hospital & Medical Center; Recruiting

Burlington, Massachusetts, United States, 01803

Contact: Melissa Dunbar, MPH 781-744-8774 melissa.r.dunbar@lahey.org

Contact: Susan Christopher, RN susan.r.christopher@lahey.org

Principal Investigator: Zoher Ghogawala, MD

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: Tonya Nelson nel02095@umn.edu

Contact: Kenneth Holton, MD holto050@umn.edu

Principal Investigator: David Polly, MD

Sub-Investigator: Kristen Jones, MD

Sub-Investigator: Christopher Martin, MD

Sub-Investigator: Ann Parr, MD

Sub-Investigator: Johnathan N Sembrano, MD

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: Tianna Bennet bennettt@hss.edu

Principal Investigator: Todd J Albert, MD

Sub-Investigator: James Farmer, MD

Sub-Investigator: Han Jo Kim, MD

Sub-Investigator: Sravisht Iyer, MD

Sub-Investigator: Sheeraz Ahmed Qureshi, MD

Sub-Investigator: Russel C Huang, MD

Columbia University; Recruiting

New York, New York, United States, 10027

Contact: Eric Leung el2933@cumc.columbia.edu

Principal Investigator: Ronald C Lehman, MD

Sub-Investigator: Paul McCormick, MD, MPH

Sub-Investigator: Peter Angevine, MD, MPH, FAANS

United States, Ohio

Cleveland Clinic Foundation; Recruiting

Cleveland, Ohio, United States, 44195

Contact: Emily Fisher FISHERE3@ccf.org

Contact: David Chelnick chelnid2@ccf.org

Principal Investigator: Edward Benzel, MD

Sub-Investigator: Michael Steinmetz, MD

Sub-Investigator: Ajit Krishnaney, MD

Sub-Investigator: Ian Kalfas, MD

Sub-Investigator: Richard Schlenk, MD

Sub-Investigator: Thomas Mroz, MD

Sub-Investigator: Jason Savage, MD

Sub-Investigator: Ghaith Habboub, MD

Sub-Investigator: Dominic Pelle, MD

United States, Pennsylvania

University of Pittsburgh; Active, not recruiting

Pittsburgh, Pennsylvania, United States, 15213

United States, Utah

University of Utah Hospital; Recruiting

Salt Lake City, Utah, United States, 84132

Contact: Sara McEvoy u0029011@utah.edu

Principal Investigator: Erica F Bisson, MD, MPH

Sub-Investigator: Andrew T Dailey, MD

Sub-Investigator: Marcus Mazur, MD

United States, Wisconsin

University of Wisconsin; Recruiting

Madison, Wisconsin, United States, 53792

Contact: Andrea Strayer, RN strayer@neurosurgery.wisc.edu

Contact: Stephanie M Wilbrand, PhD wilbrand@neurosurgery.wisc.edu

Principal Investigator: Daniel K Resnick, MD

Sub-Investigator: Darnel T Josiah, MD, MS

Sub-Investigator: Nathaniel P Brooks, MD

Sub-Investigator: Clifford Tribus, MD

Sub-Investigator: Seth K Williams, MD

Canada, Ontario

University Health Network - Toronto Western Hospital; Recruiting

Toronto, Ontario, Canada, M5T 2S8

Contact: Yuriy Petrenko Yuriy.Petrenko@uhn.ca

Contact: Yuliya Petrenko yuliya.petrenko@uhn.ca

Principal Investigator: Michael G Fehlings, MD, PhD

Sponsors and Collaborators

Lahey Clinic

Investigators

• Principal Investigator: Zoher Ghogawala, MD; Lahey Hospital & Medical Center

More Information

• Responsible Party: Lahey Clinic
• ClinicalTrials.gov Identifier: NCT03570801
• Other Study ID Numbers: 2017-047
• First Posted: June 27, 2018
• Last Update Posted: March 4, 2022
• Last Verified: February 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• 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:

Spinal Stenosis; Spondylolisthesis; Constriction, Pathologic; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Spondylolysis; Spondylosis