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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03570801
Recruitment Status : Terminated (We performed unplanned interim conditional power (CP) analyses for the primary endpoint. We pre-specified futility as CP<20%. Based on 301 patients (38% of target), CP was <20% and the independent steering committee recommended termination.)
First Posted : June 27, 2018
Last Update Posted : August 2, 2022
Sponsor:
Information provided by (Responsible Party):
Lahey Clinic

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.


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)
Actual Enrollment : 662 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
Actual Primary Completion Date : July 1, 2022
Actual Study Completion Date : July 1, 2022

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. NASS Patient Satisfaction [ Time Frame: 1 year, 2 years, 3 years, 4 years, 5 years ]
    To determine at 1 and 2 years if an expert panel review of individual cases is associated with an 8% difference in the percentage of patients who achieve at least 1) the treatment met expectations or 2) did not improve as much as hoped but would undergo the same treatment for the same outcome.


Secondary Outcome Measures :
  1. Oswestry Disability Index (ODI) [ Time Frame: Baseline, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years ]
    To determine at 1 and 2 years if an expert panel review of individual cases is associated with a greater percentage of patients who improve by more than 10 points. In addition, we will compare mean change in ODI score among patients randomized to expert panel review to those randomized to receive no review.

  2. Oswestry Disability Index (ODI) [ Time Frame: Baseline, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years ]
    To compare mean change in ODI score between patients treated with laminectomy alone versus laminectomy with instrumented lumbar fusion

  3. 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. Comparisons among groups will compare difference in the change scores.

  4. 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.

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

  6. 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.

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

  8. 36-inch Standing Plain Radiographs [ Time Frame: Baseline, 1 year ]
    To assess spine alignment.

  9. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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


Locations
Show Show 17 study locations
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: August 2, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Deidentified data would be shared with other researchers after primary analysis has been published.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: After primary analysis has been published for up to 5 years.

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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