coflex® Interlaminar Stabilization for Spinal Stenosis

(PAS003 Trial)

Recruiting at 14 trial locations

Overseen By Daniel Peterson, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Surgalign Spine Technologies

Disqualifiers: Osteoporosis, Morbid obesity, Infection, others

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

Compensation: Varies

Number of Visits: 7

Duration: 6 weeks

300 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 Coflex Interlaminar Stabilization treatment for spinal stenosis?

Research shows that the Coflex Interlaminar Stabilization treatment is effective for improving symptoms in patients with lumbar spinal stenosis, as it provides stability and helps relieve pressure on the spine. Studies have demonstrated significant improvements in pain and disability scores, and the treatment has been shown to be a cost-effective alternative to traditional spinal fusion surgery. ^{1 2 3 4 5}

Is the coflex® Interlaminar Stabilization device safe for humans?

The coflex® Interlaminar Stabilization device has been studied in clinical trials and shown to be safe for use in humans, with successful implantation and significant improvement in patients with lumbar spinal stenosis over a follow-up period of at least four years. ^{1 2 3 4 6}

How does the Coflex Interlaminar Stabilization treatment differ from other treatments for spinal stenosis?

The Coflex Interlaminar Stabilization treatment is unique because it is a minimally invasive implant that provides dynamic stabilization of the spine after decompression surgery, offering an alternative to more invasive spinal fusion procedures. It is designed to maintain motion in the spine, potentially leading to quicker recovery and less long-term stiffness compared to traditional fusion methods. ^{1 2 4 5 7}

What is the purpose of this trial?

This trial evaluates the safety and effectiveness of the coflex® device for patients with spinal stenosis and low back pain. The device is a small implant that helps stabilize the spine and relieve nerve pressure. The study aims to see how well it works over an extended period. The Coflex device has been studied extensively for its effectiveness in treating lumbar spinal stenosis and degenerative lumbar diseases, with multiple studies showing its long-term efficacy and safety.

Research Team

Fran Magee

Principal Investigator

Paradigm Spine

Eligibility Criteria

This trial is for adults with leg, buttock, or groin pain from spinal stenosis that eases when sitting. They must have significant back pain and disability, confirmed lumbar stenosis needing surgery, tried injections or 6 months of other treatments without relief, and be able to follow the study plan. Excluded are those with prior major spine surgeries, certain bone conditions, severe scoliosis or osteoporosis risks, titanium allergies, infections, specific neurological disorders like cauda equina syndrome.

Inclusion Criteria

I am mentally and physically capable of following the study's requirements.

I experience leg or groin pain that eases when I sit or bend forward.

I've had a lumbar injection or 6 months of care without relief.

Exclusion Criteria

I have had spine surgery at the specific lower back level.

I have had spine damage due to injury or cancer.

I need a lot of bone removed due to severe spine joint enlargement, which could cause instability.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo decompression surgery with additional stabilization using the coflex® Interlaminar Technology

6 weeks

1 visit (in-person) for surgery

Follow-up

Participants are monitored for safety and effectiveness after treatment, with evaluations at multiple time points

60 months

Regular visits at 6 weeks, 12, 24, 36, 48, and 60 months

Long-term Evaluation

Extended evaluation of clinical outcomes and device performance over 5 years

60 months

Treatment Details

Interventions

• coflex® Interlaminar Technology
• Decompression

Trial Overview The study evaluates a device called coflex® Interlaminar Technology used after decompression surgery in patients with degenerative spinal stenosis and low back pain. It's a long-term assessment over 2 and 5 years to see how well this technology works under actual use conditions as approved by the FDA.

Participant Groups

Group I: The coflex® Interlaminar Technology Experimental Treatment 1 Intervention

The coflex device was designed to address the clinical needs of spinal stenosis patients by providing stabilization of the affected level without fusion. The coflex is an interspinous process functional dynamic implant designed to impart a stabilizing effect at the treated level(s). The coflex device was approved by FDA in 2012.

Group II: Decompression Active Control 1 Intervention

Lumbar decompression back surgery is when a small portion of the bone over the nerve root and/or disc material from under the nerve root is removed to give the nerve root more space and provide a better healing environment.

coflex® Interlaminar Technology is already approved in United States for the following indications:

Approved in United States as Coflex Interlaminar Technology for:

• Moderate to severe lumbar spinal stenosis with or without back pain

Who Is Running the Clinical Trial?

Surgalign Spine Technologies

Lead Sponsor

Trials

4

Recruited

5,600+

Xtant Medical

Lead Sponsor

Trials

3

Recruited

5,300+

MCRA, LLC

Industry Sponsor

Trials

19

Recruited

7,500+

MCRA

Industry Sponsor

Trials

40

Recruited

11,100+

Findings from Research

The Coflex Interlaminar Stabilization Device is more cost-effective than traditional instrumented posterolateral fusion for treating lumbar spinal stenosis, with average Medicare payments of $15,182 for Coflex compared to $26,863 for fusion over five years, resulting in a cost difference of $11,681.

Patients receiving the Coflex device reported higher quality-adjusted life years (3.02) compared to those undergoing fusion (2.97), indicating that Coflex not only saves money but also provides better patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative cost effectiveness of Coflex® interlaminar stabilization versus instrumented posterolateral lumbar fusion for the treatment of lumbar spinal stenosis and spondylolisthesis. Schmier, JK., Halevi, M., Maislin, G., et al.[2023]

The coflex interlaminar stabilization implant (ILS) demonstrated a higher success rate (57.6%) compared to posterolateral fusion (46.7%) in patients with lumbar spinal stenosis, indicating its potential for better clinical outcomes after decompression surgery.

The study suggests that ILS offers superior therapeutic sustainability over time, as evidenced by improved clinical and radiographic parameters, with trends favoring ILS continuing through four years post-operation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic sustainability and durability of coflex interlaminar stabilization after decompression for lumbar spinal stenosis: a four year assessment. Bae, HW., Lauryssen, C., Maislin, G., et al.[2020]

In a study involving 60 patients with symptomatic lumbar spinal stenosis, both decompression surgery alone and decompression with the Coflex interspinous device showed significant improvements in disability and pain scores over 12 months, indicating both approaches are effective.

However, there were no significant differences in clinical outcomes or patient satisfaction between the two groups at the one-year follow-up, suggesting that the addition of the Coflex device may not provide additional benefits over standard decompression surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does an interspinous device (Coflex) improve the outcome of decompressive surgery in lumbar spinal stenosis? One-year follow up of a prospective case control study of 60 patients. Richter, A., Schütz, C., Hauck, M., et al.[2022]

The Coflex interlaminar stabilization device was successfully implanted in all 33 patients with degenerative lumbar conditions at the L5/S1 level, showing significant clinical improvement over a minimum follow-up of 4 years.

Postoperative radiological evaluations indicated increased intervertebral space height and maintained stability, while the device effectively restricted motion at the operated level without adversely affecting adjacent segments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Application of the Coflex Interlaminar Stabilization in Patients With L5/S1 Degenerative Diseases: Minimum 4-Year Follow-up. Xu, C., Mao, F., Wang, X., et al.[2017]

In a study involving patients undergoing lumbar interlaminar decompression with interspinous fixation, 76% of patients reported significant improvements in pain and function at 6 months post-treatment, indicating the efficacy of this minimally invasive procedure for spinal stenosis.

The treatment demonstrated a good safety profile, with only two minor procedure-related adverse events that resolved without further surgical intervention, suggesting it is a safe option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early Functional Outcomes in Low Back Pain Subjects with a Novel Interspinous Fusion Device: REFINE Study 6-Month Results. Falowski, SM., Raso, LJ., Mangal, V., et al.[2023]

The Coflex dynamic stabilization device resulted in significantly shorter operation times, less blood loss, and shorter hospital stays compared to posterior lumbar fusion, based on a meta-analysis of 26 studies.

In the early follow-up, patients using the Coflex device reported better functional outcomes (higher JOA and lower VAS scores) and experienced fewer complications and adjacent segment degeneration compared to those who underwent fusion surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Lumbar Dynamic Stabilization Device Coflex for Lumbar Spinal Stenosis: A Systematic Review and Meta-analysis. Li, T., Yan, J., Ren, Q., et al.[2023]

A disproportionality analysis of the MAUDE database revealed significant adverse event signals for all three interspinous spacers (Coflex, Vertiflex, and X-Stop), including issues like fracture, migration, and worsening pain.

The X-Stop device was previously removed from the market due to its adverse events profile, highlighting the importance of monitoring safety in spinal interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real world adverse events of interspinous spacers using Manufacturer and User Facility Device Experience data. Aggarwal, N., Chow, R.[2021]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Comparative cost effectiveness of Coflex® interlaminar stabilization versus instrumented posterolateral lumbar fusion for the treatment of lumbar spinal stenosis and spondylolisthesis. [2023]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Therapeutic sustainability and durability of coflex interlaminar stabilization after decompression for lumbar spinal stenosis: a four year assessment. [2020]

3. Germany pubmed.ncbi.nlm.nih.gov

Does an interspinous device (Coflex) improve the outcome of decompressive surgery in lumbar spinal stenosis? One-year follow up of a prospective case control study of 60 patients. [2022]

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

Application of the Coflex Interlaminar Stabilization in Patients With L5/S1 Degenerative Diseases: Minimum 4-Year Follow-up. [2017]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Early Functional Outcomes in Low Back Pain Subjects with a Novel Interspinous Fusion Device: REFINE Study 6-Month Results. [2023]

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

Efficacy and Safety of Lumbar Dynamic Stabilization Device Coflex for Lumbar Spinal Stenosis: A Systematic Review and Meta-analysis. [2023]

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

Real world adverse events of interspinous spacers using Manufacturer and User Facility Device Experience data. [2021]