Laminectomy vs Fusion for Lumbar Spinal Stenosis

(SLIPII Trial)

Recruiting at 16 trial locations

Overseen By Melissa Dunbar, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Lahey Clinic

Disqualifiers: Serious illness, Spondylolysis, Multilevel spondylolisthesis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 month

662 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Laminectomy vs Fusion for Lumbar Spinal Stenosis?

Research shows that decompressive lumbar laminectomy alone has a high success rate in relieving pain and restoring activity in patients with spinal stenosis, with long-term satisfaction reported by 75% of patients. However, in cases where the spine is unstable, adding a fusion procedure, such as posterior lumbar interbody fusion, can help stabilize the spine and prevent further degeneration. ^{1 2 3 4 5}

Is laminectomy with fusion generally safe for humans?

Laminectomy and fusion are common procedures for spinal issues, but they can have potential risks and complications, which are not always fully reported in studies. The safety of these procedures can vary based on individual patient factors and surgical techniques, so it's important to discuss potential risks with a healthcare provider. ^{1 5 6 7 8}

How does the treatment of laminectomy with fusion differ from other treatments for lumbar spinal stenosis?

Laminectomy with fusion involves removing part of the vertebra to relieve pressure on the spinal cord or nerves and then stabilizing the spine with screws and rods, which can be more beneficial for patients with spinal instability compared to laminectomy alone. This approach is unique because it not only decompresses the spine but also provides stability, which may prevent further degeneration and improve outcomes in patients with conditions like spondylolisthesis. ^{1 5 9 10 11}

What is the purpose of this trial?

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.

Research Team

Zoher Ghogawala, MD

Principal Investigator

Lahey Hospital & Medical Center

Eligibility Criteria

This trial is for individuals with symptomatic lumbar spinal stenosis and single-level grade I degenerative spondylolisthesis. Participants should experience back or leg pain that worsens with activity and improves with rest.

Inclusion Criteria

I have back pain that worsens with activity and eases with rest.

I have a mild slipped disc in my spine.

Exclusion Criteria

I have a crack or stress fracture in my spine.

My spine condition involves slipped vertebrae of a severe degree.

I have a severe health condition.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either decompression alone or decompression with fusion, with or without expert panel review

1 month

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with patient-reported outcomes collected at multiple time points

5 years

Annual visits (in-person)

Data Collection and Analysis

Collection of step counts and radiographic data to develop AI algorithms and assess treatment outcomes

5 years

Treatment Details

Interventions

• Expert Panel Review
• Instrumented Pedicle Screw Fusion
• Spinal Laminectomy

Trial Overview The study compares patient satisfaction between those who receive advice from an expert panel versus those who don't, in the treatment of spinal conditions. It also evaluates the effectiveness of decompression alone versus decompression plus fusion surgery.

Participant Groups

Group I: Expert Panel Review Experimental Treatment 1 Intervention

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.

Group II: No Expert Panel Review Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Lahey Clinic

Lead Sponsor

Trials

74

Recruited

245,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Posterior lumbar interbody fusion in the treatment of symptomatic spinal stenosis. [2022]

2. Italy pubmed.ncbi.nlm.nih.gov

Lumbosacral fusion with pedicular osteosynthesis. [2010]

3. United States pubmed.ncbi.nlm.nih.gov

Decompressive lumbar laminectomy for spinal stenosis. [2022]

4. Thailand pubmed.ncbi.nlm.nih.gov

Functional outcome after decompression and instrumented arthrodesis in degenerative lumbar spinal stenosis: factors influencing unsuccessful outcome change. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Laminectomy plus Fusion versus Laminectomy Alone for Lumbar Spondylolisthesis. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

A cross-sectional analysis of harms reporting in systematic reviews evaluating laminectomy. [2023]

7. Germany pubmed.ncbi.nlm.nih.gov

Supplementing decompression with instrumented fusion for symptomatic lumbar spinal stenosis-a critical appraisal of available randomized controlled trials. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Open versus endoscopic lumbar pedicle screw fixation and posterolateral fusion in a sheep model: a feasibility study. [2022]

9. Korea (South) pubmed.ncbi.nlm.nih.gov

Limited Unilateral Decompression and Pedicle Screw Fixation with Fusion for Lumbar Spinal Stenosis with Unilateral Radiculopathy: A Retrospective Analysis of 25 Cases. [2020]

10. United States pubmed.ncbi.nlm.nih.gov

Indications for fusion following decompression for lumbar spinal stenosis. [2022]

11. China pubmed.ncbi.nlm.nih.gov

[Clinical analysis of vertebral laminae reconstruction after laminectomy and pedicle screw fixation in treating lumbar spinal stenosis]. [2022]