Surgical Approaches for Spondylolisthesis

Overseen By Andrew Glennie, MD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Nova Scotia Health Authority

Must not be taking: Oral steroids

Disqualifiers: Osteoporotic fracture, Neurological disorders, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: Surgery and immediate recovery

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two surgical methods for treating spondylolisthesis, a condition where a bone in the lower spine slips out of place. The researchers aim to determine whether the midline or paramedian (side) approach better reduces infection and re-operation rates, shortens hospital stays, and lowers costs. Participants will include those with back and leg pain from single or two-level degenerative spondylolisthesis, particularly if their symptoms improve when sitting or bending forward and have persisted for over six months without improvement from other treatments. By comparing these surgical approaches, the trial seeks to identify the most effective and cost-efficient option for patients. As an unphased trial, this study provides participants the chance to contribute to valuable research that could enhance surgical outcomes and healthcare efficiency.

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 approaches are safe for lumbar spine fusion?

Research has shown that both the midline and paramedian surgical methods for lumbar spine fusion are generally safe for patients. The midline method, commonly used, improves pain, disability, and quality of life. Studies have found it to be a dependable option with few complications when performed correctly.

The paramedian method, particularly the mini-open Wiltse technique, causes less damage to muscles and soft tissues, potentially leading to quicker recovery times. Early research suggests it is safe and effective, though, like any surgery, there is some risk of infection.

Both methods are generally well-tolerated, each with its own advantages and disadvantages. The choice may depend on the specific needs of the patient and the surgeon's preference. Overall, previous research has shown these methods to have good safety records. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these surgical approaches for spondylolisthesis because they offer potentially less invasive options compared to traditional spine surgeries. The midline approach allows surgeons to access the spine directly, which could minimize muscle disruption and potentially lead to a quicker recovery. The paramedian approach, also known as the Wiltse technique, uses a path between muscles, aiming to preserve more muscle function and further reduce recovery time and postoperative pain. These methods might improve outcomes for patients who need lumbar fusion by offering alternatives that prioritize muscle preservation and faster healing.

What evidence suggests that these surgical approaches could be effective for spondylolisthesis?

This trial will compare two surgical methods for treating spondylolisthesis, a condition where a bone in the spine slips out of place. Participants in one arm of the trial will undergo the midline approach. Research shows this method often results in less blood loss and muscle damage, potentially leading to fewer complications and a faster recovery. Participants in another arm will undergo the paramedian approach, specifically using the Wiltse technique. This approach is believed to cause less muscle harm and may lower the risk of long-term back pain after surgery. One study found that this method successfully fused the spine in 94% of cases. Both methods offer advantages, and the trial aims to determine which one might be more effective overall. ^{3 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for patients with degenerative lumbar spondylolisthesis who've had back and leg pain for over 6 months that's better when sitting or bending forward. They should have tried other treatments without success and must speak English well enough to give informed consent and fill out questionnaires.

Inclusion Criteria

Sufficiently fluent in English to provide informed consent and complete questionnaires with or without the need of an interpreter.

I have long-term back pain that gets better with rest and have not improved with basic treatments.

Exclusion Criteria

I have had a fracture due to weak bones or I use steroid pills regularly.

I have had back surgery, but not a microdiscectomy.

I have a condition like MS, Parkinson's, or arthritis affecting my movement.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either a midline or paramedian surgical approach for lumbar fusion

Surgery and immediate recovery

1 visit (in-person for surgery)

Initial Follow-up

Initial follow-ups to assess post-operative recovery and collect patient-reported outcomes

6 weeks

2 visits (in-person at 2 and 6 weeks)

Extended Follow-up

Further follow-up to monitor infection rates and other outcomes

3 months

1 visit (in-person at 3 months)

Long-term Follow-up

Participants are monitored for infection rates and other outcomes over a longer period

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Surgical approach

Trial Overview

The study compares two surgical approaches for treating lumbar spondylolisthesis: the midline approach versus the paramedian approach. It aims to see which one leads to lower infection rates, fewer repeat surgeries, shorter hospital stays, and less cost after surgery.

How Is the Trial Designed?

Group I: Paramedian Approach Experimental Treatment 1 Intervention

A paramedian (i.e. Wiltse) surgical approach will be used for the exposure required to complete the lumbar fusion.

Group II: Midline Approach Experimental Treatment 1 Intervention

A midline surgical approach will be used for the exposure required to complete the lumbar fusion.

Surgical approach is already approved in United States, European Union for the following indications:

Approved in United States as Spinal fusion for:

• Degenerative lumbar spondylolisthesis
• Isthmic spondylolisthesis

Approved in European Union as Spinal fusion for:

• Degenerative lumbar spondylolisthesis
• Isthmic spondylolisthesis

Approved in United States as Decompressive laminectomy for:

• Degenerative lumbar spondylolisthesis
• Isthmic spondylolisthesis

Approved in European Union as Decompressive laminectomy for:

• Degenerative lumbar spondylolisthesis
• Isthmic spondylolisthesis

Who Is Running the Clinical Trial?

Nova Scotia Health Authority

Lead Sponsor

Trials

302

Recruited

95,300+

Andrew Glennie

Lead Sponsor

Trials

2

Recruited

100+

Published Research Related to This Trial

In a study of 22 patients undergoing surgery for L4-L5 spondylolisthesis, the percutaneous screw fixation technique resulted in less muscle injury compared to the paraspinal muscle sparing approach, as indicated by lower levels of muscle injury markers post-surgery.

While both techniques showed elevated muscle injury markers initially, the percutaneous method allowed for quicker recovery to preoperative levels, making it the preferred minimally invasive option for this type of surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Paraspinal Muscle Sparing Versus Percutaneous Screw Fixation: A Comparative Enzyme Study of Tissue Injury during the Treatment of L4-L5 Spondylolisthesis. Park, DA., Kim, SW., Lee, SM., et al.[2020]

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]

The hybrid technique combining open decompression with posterior lumbar interbody fusion (PLIF) and percutaneous pedicle screws significantly reduces postoperative wound pain and muscle trauma due to its smaller midline incision, which avoids extensive muscle dissection.

Patients undergoing this minimally invasive approach experienced shorter hospital stays, earlier mobilization, and reduced narcotic usage, while achieving long-term clinical outcomes comparable to those of traditional open surgery for spondylolisthesis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hybrid technique for posterior lumbar interbody fusion: a combination of open decompression and percutaneous pedicle screw fixation. Mobbs, RJ., Sivabalan, P., Li, J., et al.[2021]

In a comparative cost-effectiveness study involving patients with stable Grade 1 degenerative lumbar spondylolisthesis, decompression surgery without instrumented fusion was found to be significantly more cost-effective, with a cost-utility ratio of $1,040 per quality-adjusted life-year (QALY) compared to $3,281 per QALY for decompression with fusion.

Decompression alone not only improved quality of life for selected patients but also offered potential cost savings, making it a preferable option for treating this condition in specific cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cost-utility of lumbar decompression with or without fusion for patients with symptomatic degenerative lumbar spondylolisthesis. Kim, S., Mortaz Hedjri, S., Coyte, PC., et al.[2022]

Patients with degenerative spondylolisthesis who underwent decompression combined with fusion surgery experienced better outcomes compared to those who only received decompression surgery.

This suggests that adding fusion to decompression may enhance recovery and stability in patients with this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Degenerative spondylolisthesis. To fuse or not to fuse. Feffer, HL., Wiesel, SW., Cuckler, JM., et al.[2022]

In a study of 50 adolescent and young adult patients with high-grade L5-S1 spondylolisthesis, a single posterior surgical approach effectively reduced slippage by over 50% and improved lumbosacral angle without loss of correction at follow-up, demonstrating its efficacy.

While the technique showed promising results, 34% of patients experienced transient postoperative radicular deficits, highlighting the need for careful patient counseling regarding potential risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reduction and fusion in high-grade L5-S1 spondylolisthesis by a single posterior approach. Results in 50 patients. Moreau, S., Lonjon, G., Guigui, P., et al.[2018]

Lateral lumbar interbody fusion (LLIF) is an effective minimally invasive surgical technique for treating symptomatic spondylolisthesis, particularly after conservative treatments have failed.

Using 3-dimensional navigation during the procedure significantly reduces radiation exposure for both the surgeon and staff while ensuring accurate placement, enhancing the safety of the surgical intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Three-Dimensional Navigated Lateral Lumbar Interbody Fusion: 2-Dimensional Operative Video. Strong, MJ., Khalsa, SSS., Yee, TJ., et al.[2021]

In a study of 20 patients with L5-S1 spondylolisthesis, both the paraspinal muscle sparing approach and percutaneous screw fixation techniques resulted in excellent or good outcomes after 6 months, indicating their efficacy in treating this condition.

Patients who underwent percutaneous screw fixation experienced significantly lower levels of low back pain in the early postoperative period compared to those who had the paraspinal muscle sparing approach, suggesting that percutaneous fixation may be the preferred minimally invasive technique for this type of surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Paraspinal Muscle Sparing versus Percutaneous Screw Fixation : A Prospective and Comparative Study for the Treatment of L5-S1 Spondylolisthesis. Jang, KS., Kim, HS., Ju, CI., et al.[2021]

In a study of 124 patients with one-level lumbar spondylolisthesis, the minimally invasive spine surgery using intraoperative computed tomography (MISS-iCT) resulted in significantly less blood loss and shorter hospital stays compared to conventional open surgery (OS).

MISS-iCT also showed improved functional outcomes, with better visual analog scale (VAS) scores at 1 and 2 years post-surgery, while maintaining a low rate of superior-level facet violations, indicating its efficacy and safety as a surgical approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of minimally invasive spine surgery using intraoperative computed tomography integrated navigation, fluoroscopy, and conventional open surgery for lumbar spondylolisthesis: a prospective registry-based cohort study. Wu, MH., Dubey, NK., Li, YY., et al.[2018]

A surgical method involving radical bilateral laminectomy and transpedicular fixation for treating degenerative spondylolisthesis in 46 patients resulted in complete bone fusion and spinal stability in all cases after one year.

Patients experienced significant improvements in pain and disability, with a 77% reduction in low back pain and an 82% reduction in radicular pain, alongside a 57% improvement in daily living activities as measured by the Oswestry Disability Index.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Surgery for degenerative spondylolisthesis of the lumbar spine using intra-articular fusion. A prospective study]. Hrabálek, L., Wanek, T., Adamus, M., et al.[2014]

Minimally invasive (MI) decompression significantly improves range of motion (ROM) in the lumbar spine compared to traditional open laminectomy, suggesting it may be a better option for treating multilevel lumbar stenosis with adjacent spondylolisthesis.

The study indicates that MI decompression allows for effective treatment without the need for additional fusion at adjacent levels, potentially reducing the extent of surgical intervention required for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biomechanical Evaluation of Lumbar Decompression Adjacent to Instrumented Segments. Grunert, P., Reyes, PM., Newcomb, AG., et al.[2019]

In a study of 84 patients with isthmic spondylolisthesis, decompression with instrumented fusion showed significantly better long-term outcomes compared to decompression alone, including improved disability scores and reduced back pain at the 2-year follow-up.

The fusion group had a much lower reoperation rate (13%) compared to the decompression-only group (47%), indicating that decompression with fusion is a more effective and safer surgical option for treating isthmic spondylolisthesis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Decompression alone versus decompression and instrumented fusion for the treatment of isthmic spondylolisthesis: a randomized controlled trial. Azizpour, K., Schutte, P., Arts, MP., et al.[2023]

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