Laminectomy vs Fusion for Lumbar Spinal Stenosis

(SLIPII Trial)

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two surgical treatments for lumbar spinal stenosis, a condition causing back and leg pain that worsens with activity. Researchers aim to determine which treatment—decompression alone (spinal laminectomy) or decompression with fusion (instrumented pedicle screw fusion)—results in better patient satisfaction and outcomes. An expert panel will review some participants' cases to help decide the best treatment. The trial also seeks to develop a computer program to predict which surgery might work best for future patients. Individuals with pain from lumbar spinal stenosis and a single-level spinal slip (spondylolisthesis) may be suitable candidates. As an unphased trial, this study offers participants the chance to contribute to innovative research that could improve future treatment options.

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 prior data suggests that these surgical techniques are safe for treating lumbar spinal stenosis?

Studies on spinal laminectomy, a surgery to relieve pressure on the spinal cord, suggest it is generally safe. One study found that patients could walk further after the procedure, indicating it may help reduce nerve pain. Another study showed that laminectomy is safe for older adults with spinal narrowing, though some patients required additional surgeries later.

Research on pedicle screw fusion, which uses screws to stabilize the spine, shows mixed safety results. One study found it to have good short-term outcomes, but another compared different screw techniques and found varied safety profiles. While some patients experience positive results, there can be risks, such as the need for further surgeries.

Both treatments have been studied extensively. Although generally safe, each has potential risks and benefits. Discussing these with a healthcare provider is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores two different surgical approaches for treating lumbar spinal stenosis: laminectomy and fusion. Unlike standard treatments that may rely solely on a surgeon's judgment, this trial introduces an expert panel review, where a network of spine experts examines patient images and offers opinions on whether decompression alone or decompression with fusion is the best approach. This collaborative review could lead to more personalized treatment decisions, potentially improving patient outcomes by tailoring surgery to individual needs. Additionally, it offers a comparison between traditional decision-making and an expert-supported process, which could revolutionize how surgical options are selected for spinal stenosis.

What evidence suggests that this trial's treatments could be effective for lumbar spinal stenosis?

Research has shown that spinal laminectomy, a surgery to relieve pressure on the spinal cord, effectively helps many people with lumbar spinal stenosis. Studies indicate that 75% to 90% of patients experience significant pain relief and improved mobility after the surgery. However, about 33% of patients may not achieve complete relief. In this trial, some participants will undergo spinal laminectomy, while others will receive instrumented pedicle screw fusion, which uses screws and rods to stabilize the spine after decompression. This method aims to prevent future spine instability, but evidence about its effectiveness for lumbar spinal stenosis alone is less clear. Overall, both treatments in this trial aim to improve movement and reduce pain, with laminectomy showing a good success rate in many cases. ^{6 7 8 9 10}

Who Is on the Research Team?

Zoher Ghogawala, MD

Principal Investigator

Lahey Hospital & Medical Center

Are You a Good Fit for This Trial?

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 severe health condition.

I have a crack or stress fracture in my spine.

My spine condition involves slipped vertebrae of a severe degree.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9473837/

Long-Term Outcomes of Laminectomy in Lumbar Spinal ... Conclusion Our study provides low-quality evidence suggesting that patients undergoing laminectomy for LSS have less disability and pain and can ...

2. thespinejournalonline.com thespinejournalonline.com/article/S1529-9430(22)00992-5/fulltext

Predictors for failure after surgery for lumbar spinal stenosis Thirty-three percent of patients operated for lumbar spinal stenosis report failure of treatment. •. The strongest predictors for failure ...

3. cuellarspine.com cuellarspine.com/insights/laminectomy-without-fusion/

Laminectomy Without Fusion: Benefits & Success Rate According to data, the success rates for this procedure range from 75% to 90%, depending on various factors such as the patient's overall health ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5760430/

Functional outcomes of laminectomy and laminotomy for the ... No statistically significant differences were demonstrated between laminectomy and laminotomy outcomes, for LBP, leg pain or disability in our institute.

5. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2790425

Comparison of 3 Minimally Invasive Surgical Techniques ... In the present trial of patients treated surgically for lumbar spinal stenosis, there were no differences in the effectiveness between the 3 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11943498/

Comparative Analysis of Pedicle Screw Fixation and ... This study aims to evaluate and compare the clinical and surgical outcomes of lumbar fusion using pedicle screws and rods with those achieved using the ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S1878875024008520

Efficacy and Safety of Cortical Bone Trajectory Screws ... Cortical bone trajectory instrumentation provides favorable perioperative outcomes compared to pedicle screws for single-level lumbar spinal stenosis and ...

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39404118/

Evaluation of the Efficacy and Safety of FFX Facet Cages ... The study evaluated the long-term safety and efficacy of the FFX facet cage versus pedicle screw (PS) fixation in patients with lumbar spinal stenosis (LSS).

9. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2022.998173/full

Safety and efficacy of unilateral and bilateral pedicle screw ... The purpose of this study was to compare the safety and efficacy of unilateral vs. bilateral pedicle screw fixation (BPSF) for lumbar degenerative diseases.

10. tandfonline.com tandfonline.com/doi/full/10.2147/JPR.S522987

Safety and Efficacy of Interspinous Fixation Device via ... Instrumented posterior arthrodesis of the lumbar spine: prospective study evaluating fusion outcomes in patients receiving an interspinous fixation device ...