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New spinal implant shows promise for chronic back pain

NCT ID NCT04416321

Disease control Sponsor: Invibio Ltd 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Sep 10, 2026 · Updated 3 times

Summary

This study tested a special spinal implant (the Keos Lumbar Interbody Fusion Device) in 25 adults with degenerative disc disease or related spine conditions. The goal was to see how well the device helped bones fuse and how it affected pain and quality of life. Participants had spinal fusion surgery using the device, and results were tracked over time.

What this could mean

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

Active substance
Keos Lumbar Interbody Fusion Device (a spinal implant made of PEEK-OPTIMA HA enhanced material)
What this could lead to
If successful, this device could provide a safe and effective option for spinal fusion surgery, potentially reducing back pain and improving quality of life.
What could go wrong
This is a small, single-center study with only 25 participants and no comparison group. Results may not apply to all patients, and the device may not perform better than existing options.

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

25 people

The number who actually took part.

Started

Jul 2021

Finished

Jan 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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. Aged 18 years of age or older. 2. Primary diagnosis of symptomatic degenerative disc disease (DDD) or symptomatic degenerative disc disease (DDD) with spondylolisthesis (Grade 1), or retrolisthesis, at one or two contiguous levels from L2 to S1. 3. Have discogenic back pain. 4. Suitable for transforaminal lumbar interbody fusion (TLIF) surgery. 5. Indicated for surgical treatment with the Keos Lumbar IBFD with autologous bone graft. 6. Completed at least 6 months of conservative non-operative treatment. 7. Female subjects of childbearing age must have a negative pregnancy test. 8. Able to understand this clinical study, co-operate with procedures. 9. Able to give voluntary, written informed consent to participate. Exclusion Criteria: 1. Not undergone previous spinal surgery at the affected disc level(s). 2. Evidence of tumour and/or malignant disease. 3. Known osteoporosis or severe osteopenia. 4. Known rheumatoid arthritis, ankylosing spondylitis or who are immunocompromised. 5. Known allergy to the material used in the instrumentation. 6. Evidence of an active infection. 7. Any conditions outlined as contraindicated in the Instructions for Use. 8. Receiving any drug treatment that may affect bone metabolism. 9. Female subjects who are pregnant or lactating. 10. Current smokers or have stopped smoking less than 6 months ago. 11. Known drug or alcohol abusers. 12. Currently enrolled in a clinical study.

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Conditions

The condition(s) this trial relates to.

intervertebral disk degenerative disorder lumbar disk degenerative disorder spondylolisthesis

As listed by the trial registrant

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

Degenerative disc disease Retrolisthesis Spondylolisthesis

Contacts and locations

Locations

  • Neurosurgical Associates of Lancaster

    Lancaster, Pennsylvania, 17601, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.