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Spinal implant aims to stabilize the back and ease pain

NCT ID NCT02555280

Disease control Sponsor: Companion Spine, LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 02, 2026 · Last updated Jul 02, 2026

Summary

This trial studies a device called coflex, a small implant placed in the spine after decompression surgery for lumbar spinal stenosis (a narrowing of the spinal canal that causes back and leg pain). The study includes 40 adults with moderate to severe stenosis and low back pain. Half receive decompression plus the coflex implant, and half receive decompression alone. Researchers track pain, disability, and complications over 2 to 5 years to see if the implant improves outcomes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
coflex® Interlaminar Technology (a spinal implant)
What this could lead to
If successful, this implant could offer a more stable, lasting solution for people with spinal stenosis and low back pain, potentially reducing the need for repeat surgeries.
What could go wrong
This is a small, early-stage study with only 40 participants, so results may not apply to everyone. The implant also carries risks like infection, device failure, or nerve damage.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

40 people

The number who actually took part.

Started

Sep 2019

Finished

May 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Radiographic confirmation of at least moderate lumbar stenosis at one or two contiguous levels from L1-L5 that require surgical decompression. 2. Visual Analog Scale back pain score of at least 50 mm on a 100 mm scale. 3. Neurogenic claudication as defined by leg/buttocks or groin pain that can be relieved by flexion such as sitting in a chair. 4. Subject has undergone at least one lumbar injection at any prior time point, AND/OR at least 6 months of prior conservative care without adequate and sustained symptom relief. 5. Skeletally mature 6. Oswestry Low Back Pain Disability Questionnaire score of at least 20/50 (40%). 7. Psychosocially, mentally, and physically able to fully comply with this protocol, including adhering to scheduled visits, treatment plan, completing forms, and other study procedures. 8. Personally signed and dated informed consent document prior to any study-related procedures indicating that the patient has been informed of all pertinent aspects of the trial. Exclusion Criteria: 1. Prior fusion or decompressive laminectomy at index lumbar level. 2. Radiographically compromised vertebral bodies at any lumbar level(s) caused by current or past trauma or tumor (e.g., compression fracture). 3. Severe facet hypertrophy that requires extensive bone removal which would cause instability. 4. Isthmic spondylolisthesis or spondylolysis (pars fracture). 5. Degenerative lumbar scoliosis (Cobb angle of greater than 25°). 6. Osteoporsis or is at increased risk of osteoporosis. 7. Back or leg pain of unknown etiology. 8. Axial back pain only, with no leg, buttock, or groin pain. 9. Morbid obesity defined as a body mass index \> 40. 10. Known allergy to titanium, titanium alloys, or MR contrast agents. 11. Active or chronic infection - systemic or local. 12. Cauda equina syndrome, defined as neural compression causing neurogenic bowel (rectal incontinence) or bladder (bladder retention or incontinence) dysfunction.

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Conditions

The condition(s) this trial relates to.

Low Back Pain lumbar spinal stenosis spinal stenosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Spinal stenosis lumbar

Contacts and locations

Locations

  • 01L_Northshore University Health System

    Evanston, Illinois, 60201, United States

  • 03L_Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107, United States

  • 24_Unity Surgical Center, LLC

    Lafayette, Indiana, 47905, United States

  • Austin Neurosurgeons

    Austin, Texas, 78746, United States

  • Central Cost Neurological Surgery

    San Luis Obispo, California, 93401, United States

  • Cervical Disc Center of Los Angeles

    Santa Monica, California, 90404, United States

  • Desert Institute for Spine Care (DISC)

    Phoenix, Arizona, 85020, United States

  • Northwell Health Physician Partners Orthopaedic Institute at Great Neck

    Great Neck, New York, 11021, United States

  • Southern Oregon Orthpaedics

    Medford, Oregon, 97504, United States

  • Spine Institute of Louisiana

    Shreveport, Louisiana, 71101, United States

  • Summit Spine

    Portland, Oregon, 97225, United States

  • Sutter Health

    Sacramento, California, 95816, United States

  • Tallahassee Neurological Clinic

    Tallahassee, Florida, 32308, United States

  • UC Health Spine Center

    Aurora, Colorado, 80045, United States

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