Decompression vs. Fusion Surgery for Spinal Wear

Overseen By Theresa L Chua, BS/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

Trial Summary

What is the purpose of this trial?

Adjacent segment disease (ASD) in the lumbar spine is a well-known sequela of lumbar fusion surgery. The annual incidence of adjacent level re-operation is approximately 3% with a ten-year prevalence of 20-30%. Frequently, the surgical treatment involves decompression of the adjacent level coupled with extension of the instrumentation and fusion. Advocates of this paradigm cite the altered kinematics and biomechanics of levels adjacent to a lumbar fusion mass. Furthermore, decompressed levels adjacent to a fused segments are associated with higher rates of ASD in retrospective studies. Yet, a retrospective review of higher quality data concluded decompression adjacent to single-level fusion provides similar outcomes compared to fusions extending across the decompressed segments. Given the conflicting data currently available, higher quality data are needed to guide surgical decision-making in ASD. The purpose of this trial is to prospectively compare decompression and decompression with fusion in patients with lumbar ASD.

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 Decompression vs. Fusion Surgery for Spinal Wear?

Research shows that both decompression and fusion surgeries can improve pain, function, and quality of life for patients with degenerative spinal conditions. However, studies have not found clear evidence that adding fusion to decompression provides additional benefits over decompression alone. ^{1 2 3 4 5}

Is decompression or fusion surgery for spinal wear generally safe?

Both decompression and fusion surgeries for spinal issues are generally considered safe, but decompression alone tends to have fewer complications, such as less blood loss and shorter hospital stays, compared to when it is combined with fusion. ^{4 6 7 8 9}

How is decompression surgery different from other treatments for spinal wear?

Decompression surgery, which involves relieving pressure on the spinal cord or nerves, is unique because it can be performed without fusion, leading to shorter hospital stays, less operative time, and lower surgical costs compared to when fusion is added. Studies have shown that decompression alone is as effective as decompression with fusion for certain spinal conditions, making it a simpler and potentially less risky option. ^{1 2 8 10 11}

Research Team

Daniel Tobert, MD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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 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]

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 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 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]

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]

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 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]

References

1. United States 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. [2022]

2. United States 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. [2023]

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

Decompression with fusion versus decompression in the treatment of lumbar spinal stenosis: A systematic review and meta-analysis. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

Lumbar Decompression Versus Spinal Fusion in a Private Outpatient Setting: A Retrospective Study with Three Years of Follow-up. [2021]

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

Patterns in Decompression and Fusion Procedures for Patients With Lumbar Stenosis After Major Clinical Trial Results, 2016 to 2019. [2023]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Decompression Alone Compared to Decompression With Fusion in Patients With Lumbar Spondylolisthesis: Systematic Review, Meta-Analysis, and Meta-Regression. [2022]

7. China 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. [2022]

8. United States 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). [2022]

9. England pubmed.ncbi.nlm.nih.gov

A rethink of fusion surgery for lumbar spinal stenosis. [2022]

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

A Randomized, Controlled Trial of Fusion Surgery for Lumbar Spinal Stenosis. [2022]

11. United States 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. [2021]