Decompression vs. Fusion Surgery for Spinal Wear

Overseen By Amelia L Osgood, BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Uninstrumented fusions, Traumatic etiologies, Neoplastic etiologies, Infectious etiologies, Pre-existing instability, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: Hospital stay post-operation

96 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two surgical options for treating lower spine issues caused by past fusion surgery: decompression surgery alone and decompression with additional fusion (extension fusion). The goal is to determine which method is more effective for individuals experiencing pain or issues in their lumbar spine after previous fusion surgery. Participants must have undergone lumbar fusion surgery at least a year ago and continue to experience symptoms unresponsive to other treatments. Identifying the most effective surgical option can enhance future care for those with spinal problems post-fusion surgery. As a Phase 2 trial, this research measures the effectiveness of each surgical option in an initial, smaller group, allowing participants to contribute to advancements in spinal care.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study found decompression surgery to be safe for most patients. Research shows that spinal decompression works well in 71% to 89% of cases, with no major issues like spinal instability over two years, indicating that most patients tolerate it well.

For decompression with fusion, studies suggest effectiveness, but some risks exist. These risks include the possibility of needing additional surgery due to issues with surgical hardware or problems in adjacent spine areas. However, fusion techniques often succeed, with some methods proving over 90% effective.

Both decompression alone and with fusion have specific safety considerations. Patients should consult their doctors to determine the best option for their condition. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about decompression surgery for spinal wear because it offers a less invasive option compared to the traditional fusion surgery. Unlike fusion, which involves permanently joining two or more vertebrae together, decompression surgery focuses on relieving pressure on the spinal cord or nerves without altering the spine's structure dramatically. This can potentially lead to quicker recovery times and reduced risk of complications, making it an attractive option for both patients and doctors seeking effective pain relief and improved mobility.

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

This trial will compare decompression surgery alone with decompression combined with extension fusion surgery. Studies have shown that decompression surgery can relieve symptoms of lumbar spinal stenosis, a narrowing of the spinal canal. However, long-term issues might still occur in about 90% of patients. Another study found that adding fusion surgery, which involves joining two or more bones in the spine, to decompression surgery can provide similar results to decompression alone, even with degenerative spondylolisthesis, where one vertebra slips over another.

Fusion surgeries have successfully reduced problems in spine segments next to a previous surgery site, known as adjacent segment disease. One study reported a 97% success rate in achieving bone fusion in patients without degeneration, demonstrating strong effectiveness for spinal stability. While both treatments have their benefits, further research is needed to determine which better prevents the need for additional surgeries in the future. ^{5 6 7 8 9}

Who Is on the Research Team?

Daniel Tobert, MD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

This trial is for adults who've had lumbar fusion surgery involving L2 to the sacrum and are experiencing symptoms at the level above their fusion despite six weeks of non-surgical treatment. They should be at least one year post-op from a previous instrumented posterior lumbar fusion. Those with uninstrumented fusions, trauma, tumors, infections at the adjacent segment, prior pelvic fixations or instability won't qualify.

Inclusion Criteria

I have ongoing symptoms despite 6 weeks of non-surgical treatment.

I have had spine surgery involving L2 to the sacrum.

I had back surgery over a year ago.

Exclusion Criteria

I have a condition caused by trauma, cancer, or infection near a specific body part.

My spine is stable and doesn't move more than 3mm in different positions.

I have had a lumbar fusion surgery without any metal implants.

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 extension of fusion for lumbar adjacent segment disease

Hospital stay post-operation

1 visit (in-person for surgery)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of post-operative narcotic utilization, pain intensity, anxiety, depression, and global health

2 years

Regular follow-up visits at 3 months, 6 months, 1 year, and 2 years post-operation

What Are the Treatments Tested in This Trial?

Interventions

• Decompression
• Extension Fusion

Trial Overview The study aims to compare two surgical approaches for Adjacent Segment Disease in the spine: decompression alone versus decompression combined with an extension of existing spinal instrumentation and fusion. Participants will be randomly assigned to either group to see which method is more effective.

How Is the Trial Designed?

Group I: Observational: Extension Fusion Experimental Treatment 1 Intervention

Eligible patients may have a preference for the surgical procedure they wish to have. In these instances, they may choose to undergo a decompression alone or a decompression with extension of fusion. These patients are eligible for the study and will be enrolled under observational arms. This arm refers to the decompression with extension of fusion observational study arm.

Group II: Observational: Decompression Experimental Treatment 1 Intervention

Eligible patients may have a preference for the surgical procedure they wish to have. In these instances, they may choose to undergo a decompression alone or a decompression with extension of fusion. These patients are eligible for the study and will be enrolled under observational arms. This arm refers to the decompression alone observational study arm.

Decompression is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Spinal Decompression for:

• Lumbar spinal stenosis
• Degenerative spondylolisthesis
• Adjacent segment disease

Approved in United States as Lumbar Decompression for:

• Lumbar spinal stenosis
• Degenerative spondylolisthesis
• Adjacent segment disease

Approved in Canada as Decompression Surgery for:

• Lumbar spinal stenosis
• Degenerative spondylolisthesis
• Adjacent segment disease

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Published Research Related to This Trial

In a meta-analysis of 13 studies involving 29,066 patients, decompression with fusion was found to significantly increase complications, hospital stay length, operative time, and blood loss compared to decompression alone.

Despite a lower reoperation rate in the fusion group, there were no significant differences in pain relief or functional outcomes between decompression with fusion and decompression alone, indicating that fusion may not provide additional clinical benefits for lumbar spinal stenosis treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Decompression with fusion versus decompression in the treatment of lumbar spinal stenosis: A systematic review and meta-analysis. Chen, B., Lv, Y., Wang, ZC., et al.[2022]

In a study of 7,331 patients who underwent decompression surgery for lumbar spinal stenosis with spondylolisthesis, the need for subsequent fusion surgery was relatively low, with rates of 6.7% at 5 years for public insurance patients and 14.6% for private insurance patients.

Key risk factors for requiring secondary fusion included being under 70 years old, having neurogenic claudication, and having rheumatoid arthritis or collagen vascular diseases, highlighting the importance of these factors in surgical decision-making.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The necessity and risk factors of subsequent fusion after decompression alone for lumbar spinal stenosis with lumbar spondylolisthesis: 5 years follow-up in two different large populations. Urakawa, H., Jones, T., Samuel, A., et al.[2021]

From 2016 to 2019, the use of decompression with fusion for lumbar stenosis and degenerative spondylolisthesis increased significantly, with 82.6% of patients undergoing this procedure despite evidence suggesting decompression alone is equally effective.

Factors such as older age, insurance status, and hospital region influenced the choice of surgical procedure, indicating that patient demographics and hospital characteristics play a crucial role in treatment decisions, even when clinical evidence suggests otherwise.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patterns in Decompression and Fusion Procedures for Patients With Lumbar Stenosis After Major Clinical Trial Results, 2016 to 2019. Sastry, RA., Chen, JS., Shao, B., et al.[2023]

In a study of 247 patients aged 50-80 with 1-2 level spinal stenosis, decompression surgery alone was found to be equally effective as decompression combined with fusion over a follow-up of 2 and 5 years.

Choosing decompression alone significantly reduced perioperative morbidity, length of hospital stay (4.1 days vs. 7.4 days for fusion), surgical time, and costs, making it a preferable option for older patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Commentary on: A randomized controlled trial of fusion surgery for lumbar spinal stenosis (Forsth P, Ólafsson G, Carlsson T, Frost A, Borgström F, Fritzell P, et al. N Eng J Med 2016;374:1414-23). Epstein, NE.[2022]

In a review of six randomized controlled trials involving 650 patients, the addition of fusion to decompression surgery for lumbar degenerative spondylolisthesis did not show significant improvements in pain relief or disability compared to decompression alone.

The study found no notable differences in postoperative complications or the need for secondary operations between the two groups, suggesting that decompression alone may be sufficient for treatment without the added risks or costs of fusion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The necessity or not of the addition of fusion to decompression for lumbar degenerative spondylolisthesis patients: A PRISMA compliant meta-analysis. Wu, J., Zhang, J., Xu, T., et al.[2023]

In a systematic review of 12 studies involving 14,693 patients, decompression alone for lumbar spinal stenosis with degenerative spondylolisthesis was found to have a lower complication rate and less operative time compared to decompression combined with fusion.

The study indicated that while decompression plus fusion resulted in higher complication rates and increased blood loss, there were no significant differences in overall reoperation rates or patient-reported outcomes between the two treatment approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness and safety of decompression alone versus decompression plus fusion for lumbar spinal stenosis with degenerative spondylolisthesis: a systematic review and meta-analysis. Shen, Z., Guan, X., Wang, R., et al.[2022]

A meta-analysis of two recent multicenter RCTs found that decompression plus fusion for lumbar spinal stenosis resulted in significantly more blood loss and longer operative times compared to decompression alone.

Despite the increased surgical complexity and risks associated with fusion, there were no significant differences in recovery outcomes, such as hospital stay or pain levels, suggesting that fusion may not be necessary for all patients with lumbar stenosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A rethink of fusion surgery for lumbar spinal stenosis. Wu, AM., Tong, TJ., Wang, XY.[2022]

In a study of 247 patients aged 50 to 80 with lumbar spinal stenosis, combining fusion surgery with decompression surgery did not lead to better clinical outcomes compared to decompression surgery alone, as measured by the Oswestry Disability Index and a 6-minute walk test at 2 and 5 years post-surgery.

Patients who underwent fusion surgery experienced longer hospital stays, increased operating time, more bleeding, and higher surgical costs, indicating that the additional procedure may not provide sufficient benefits to justify these risks and expenses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized, Controlled Trial of Fusion Surgery for Lumbar Spinal Stenosis. Försth, P., Ólafsson, G., Carlsson, T., et al.[2022]

In a study of 3993 patients across 13 studies, decompression with fusion showed greater improvement in disability and pain reduction compared to decompression alone, indicating it may be more effective for lumbar spondylolisthesis.

While decompression with fusion resulted in better outcomes, it also led to longer surgeries, more blood loss, and longer hospital stays, suggesting that decompression alone might be safer and more suitable for younger patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Decompression Alone Compared to Decompression With Fusion in Patients With Lumbar Spondylolisthesis: Systematic Review, Meta-Analysis, and Meta-Regression. Pranata, R., Lim, MA., Vania, R., et al.[2022]

In a study of 33,912 patients who underwent spinal decompression surgery, those who also had fusion surgery faced significantly higher risks of adverse outcomes, including increased odds of 30-day mortality and reoperation.

Fusion surgery was associated with a 4.3-fold greater likelihood of complications compared to decompression alone, suggesting that surgeons should carefully evaluate the necessity of fusion in treating degenerative lumbar disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rates, Predictive Factors, and Adverse Outcomes of Fusion Surgery for Lumbar Degenerative Disorders in Ontario, Canada, Between 2006 and 2015: A Retrospective Cohort Study. Blackett, J., McClure, JA., Kanawati, A., et al.[2022]

In a study of 71 patients with degenerative spinal pathologies, both lumbar decompression and spinal fusion surgeries led to significant long-term improvements in pain, function, and quality of life, as measured at 12 and 36 months post-surgery.

Lumbar decompression had a lower complication rate, with only a 4% recurrence of lumbar disc hernia, suggesting it may be a safer option compared to spinal fusion for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lumbar Decompression Versus Spinal Fusion in a Private Outpatient Setting: A Retrospective Study with Three Years of Follow-up. Oliveira, IO., Lenza, M., Antonioli, E., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2223332/

The outcome of spinal decompression surgery 5 years on Minimum 10-year outcome of decompressive laminectomy for degenerative lumbar spinal stenosis. Spine. 2000;25:1754–1759. doi: 10.1097/00007632-200007150 ...

2. boneandjoint.org.uk boneandjoint.org.uk/Article/10.1302/0301-620X.106B7.BJJ-2023-1160.R2

five-year clinical results from a randomized clinical trial We compared decompression alone to decompression with fusion surgery for lumbar spinal stenosis, with or without degenerative spondylolisthesis (DS).

3. sciencedirect.com sciencedirect.com/science/article/pii/S2772529425001468

Comparative analysis of lumbar spinal decompression Spinal stenosis is a degenerative disorder characterized by narrowing of the spinal canal, leading to compression of the spinal cord and nerve roots.

4. journal.parker.edu journal.parker.edu/article/131983-clinical-and-imaging-outcomes-of-non-surgical-spinal-decompression-for-lumbar-intervertebral-disc-lesions-a-case-series

CLINICAL AND IMAGING OUTCOMES OF NON ... Even if spinal decompressive surgeries have reduced pain, long-term degenerative changes are evident in 90% of patients, with loss of disc ...

5. nejm.org nejm.org/doi/full/10.1056/NEJMoa2100990

Decompression with or without Fusion in Degenerative ... Comparative effectiveness of microdecompression alone vs decompression plus instrumented fusion in lumbar degenerative spondylolisthesis.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7882820/

Patient-Reported Outcomes Following Lumbar ... The aim of this study was to review a large dataset from our extensive and growing spinal surgery database to evaluate outcomes of simple decompression surgery ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6319572/

Long-Term Safety and Efficacy of Minimally Invasive Lumbar ... MILD showed excellent long-term durability, and there was no evidence of spinal instability through 2-year follow-up. Reoperation and spinal fracture rates are ...

8. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2828754

Surgeon Recommendation and Outcomes in Patients With ... These findings suggest that adding fusion to decompression based on individual patient evaluation might not improve clinical outcomes.

9. oregonspineanddisc.com oregonspineanddisc.com/research

Research on Spinal Decompression Most research has shown spinal decompression to be successful in 71% to 89% of patients. More than 10 different research studies have been conducted.