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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a treatment for spinal stenosis, a condition where the spaces in the spine narrow, causing back and leg pain. The study tests the coflex® Interlaminar Technology, a small device implanted in the spine to provide stability after decompression, which relieves pressure on the spinal nerves. This treatment suits individuals with moderate lumbar stenosis and persistent back pain who have not found relief from other treatments like injections or physical therapy. Participants should also experience pain relief when sitting down or bending forward. As an unphased trial, this study offers an opportunity to explore innovative treatment options for spinal stenosis.

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 the coflex® Interlaminar Technology is safe for treating spinal stenosis?

Research shows that the coflex® Interlaminar Technology is generally well-tolerated by patients with lumbar spinal stenosis, a condition involving the narrowing of spaces in the spine. This device stabilizes the spine without requiring fusion surgery and has received FDA approval since 2012, indicating a certain level of safety.

In earlier studies, some patients experienced minor issues like back pain or swelling, but serious side effects were rare. Overall, data indicates that most people do not encounter major problems with this treatment. The coflex implant is designed to be both flexible and strong, providing effective support for the spine.

The safety of the coflex device is supported by its FDA approval and findings from clinical studies. These studies confirm that the coflex device is a safe option for treating spinal stenosis when used as directed. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about coflex® Interlaminar Technology because it offers a unique way to treat spinal stenosis without resorting to spinal fusion, which is a common approach today. The coflex device is a small implant that stabilizes the spine while allowing for more natural movement, unlike fusion, which permanently locks vertebrae together. This dynamic stabilization can help maintain the spine's flexibility and potentially reduce recovery time and postoperative complications. Additionally, coflex is designed to be less invasive than traditional fusion surgery, making it an attractive option for patients and doctors alike.

What evidence suggests that the coflex® Interlaminar Technology and decompression could be effective for spinal stenosis?

Research has shown that the coflex® Interlaminar Technology effectively treats lumbar spinal stenosis, a condition where the spine narrows and causes pain. In this trial, participants may receive the coflex device, which studies have found can provide lasting pain relief and stability by supporting the spine without requiring a full fusion. This FDA-approved device is designed to allow movement and reduce pain over the long term. Another group in this trial will undergo decompression surgery, which involves removing a small portion of bone or disc material to relieve pressure on the nerve root. The trial will compare the outcomes of the coflex device with decompression surgery to determine the most effective treatment for spinal stenosis and related lower back pain. ^{1 5 6 7 8}

Who Is on the Research Team?

Fran Magee

Principal Investigator

Paradigm Spine

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3964032/

Comparative cost effectiveness of Coflex® interlaminar ... The Coflex Interlaminar Stabilization Device was found to be cost effective compared to instrumented posterolateral fusion for treatment of lumbar spinal ...

2. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf11/p110008b.pdf

Summary of Safety & Effectiveness Data (SSED) The coflex® Interlaminar Technology is an interlaminar stabilization device indicated for use in one or two level lumbar stenosis from L1-L5 in skeletally ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT01316211

Study Details | NCT01316211 | Clinical Trial Comparing ... This was a randomized multicenter study to collect prospective data for potential improvement in the therapy of low back pain during the treatment of spinal ...

4. coflexsolution.com coflexsolution.com/why-coflex/

Why Coflex The Coflex device is the exclusive posterior lumbar motion preservation solution with proven long-term outcomes for durable pain relief and stability.

5. sciencedirect.com sciencedirect.com/science/article/pii/S0967586820315198

Coflex interspinous process dynamic stabilization for ... Coflex interspinous process dynamic stabilization is effective in the long-term treatment of lumbar spinal stenosis, the ISH and IFH of implanted segment could ...

6. coflexsolution.com coflexsolution.com/

Home | Coflex® The Coflex device can be used to treat LSS and is a single-piece titanium implant that is stable, strong, and flexible enough to give your spine the support it ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT00534235

Study Details | NCT00534235 | Post-Approval Clinical Trial ... The coflex® Interlaminar Technology is an interlaminar stabilization device indicated for use in one or two level lumbar stenosis from L1-L5 in skeletally ...

8. coflexsolution.com coflexsolution.com/clinical-research/

Clinical Research & Data | Coflex® The Coflex Interlaminar Stabilization device is the only lumbar spinal device with Level 1 evidence in two separate clinical studies.