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Spinal Implant

coflex® Interlaminar Stabilization for Spinal Stenosis (PAS003 Trial)

N/A

Recruiting

Research Sponsored by Surgalign Spine Technologies

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Neurogenic claudication as defined by leg/buttocks or groin pain that can be relieved by flexion such as sitting in a chair.

Neurogenic claudication as defined by leg/buttocks or groin pain that can be relieved by flexion such as sitting in a chair

Must not have

Prior fusion or decompressive laminectomy at index lumbar level

Radiographically compromised vertebral bodies at any lumbar level(s) caused by current or past trauma or tumor (e.g., compression fracture)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 6 weeks, 12, 24, 36, 48, 60 months

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While not explicitly listed here, potential side effects may include typical surgical complications such as infection risk at the surgical site; discomfort or pain; possible allergic reactions to materials if unknown allergies exist; nerve damage; bleeding; blood clots.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

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My bones have stopped growing.

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My back pain is severe, scoring at least 50 out of 100.

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My back pain is severe, scoring at least 50 out of 100.

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I have confirmed moderate spinal narrowing in my lower back needing surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have had spine damage due to injury or cancer.

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

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I have a spine curve of more than 25 degrees.

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I only have pain in my back, not in my legs, buttocks, or groin.

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I have osteoporosis or am at high risk for it.

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I have a slipped vertebra or a small stress fracture in my back.

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My BMI is over 40, indicating morbid obesity.

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I have cauda equina syndrome with bowel or bladder control issues.

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I do not have any ongoing infections.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ procedure, 6 week, 12, 24, 36, 48, 60 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~procedure, 6 week, 12, 24, 36, 48, 60 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and procedure, 6 week, 12, 24, 36, 48, 60 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Composite Clinical Success (CCS)

coflex performance compared to IDE

coflex performance compared to decompression alone from ESCADA study.

Secondary study objectives

Change in Oswestry Disability Index (ODI)

Change in Visual Analog Scale (VAS) for leg pain

Back

+4 more

Other study objectives

Safety Evaluation

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: The coflex® Interlaminar TechnologyExperimental Treatment1 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: DecompressionActive Control1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

coflex® Interlaminar Technology

2016

N/A

~5050

0 / 16Eligibility criteria met