A prospective, non-comparative, multi-center, post-market clinical study to evaluate the safety and performance of PEEK-OPTIMA™ HA enhanced interbody cages for the treatment of degenerative disc disease and spondylolisthesis in the lumbar spine

NCT ID NCT03928041

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 10, 2026 · Last updated Sep 10, 2026

Summary

The purpose of this trial is to collect clinical outcomes including radiographic and CT outcomes in patients who undergo interbody spinal fusion using the EVOS Lumbar Interbody System.

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

22 people

The number who actually took part.

Started

Jun 2019

Finished

Sep 2023

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: * Is the subject aged 18 years of age or older and skeletally mature? * Does the subject have a primary diagnosis of symptomatic degenerative disc disease (DDD) or symptomatic degenerative disc disease (DDD) with spondylolisthesis (Grade 1) at one or two contiguous levels from L2 to S1? * Does the subject have discogenic back pain with degeneration of the disc confirmed by medical history, radiographic examination and MRI (MRI must be obtained within the 6 months prior to subject surgery and radiographs obtained within 3 months prior to subject surgery)? * Is the subject judged by the Investigator to be suitable for transforaminal lumbar interbody fusion (TLIF) surgery based on their medical history? * Is the subject indicated for surgical treatment with the EVOS Lumbar Interbody System with autologous bone graft? * Has the subject completed at least 6 months of conservative non-operative treatment without obtaining adequate symptomatic relief? * If the subject is female and of childbearing age, do they have a negative pregnancy test (by Beta HCG qualitative analysis), or do they have a history of a surgical sterilisation, or a history of no menses in the past twelve months? * Is the subject, in the opinion of the Investigator, able to understand this clinical study, co-operate with the procedures and are they willing to return to the hospital for all the required post-operative follow-ups? * Is the subject able to give voluntary, written informed consent to participate in this clinical study and from whom consent has been obtained? Exclusion Criteria: * Has the subject undergone previous spinal surgery at the affected disc level(s), excluding discectomy and laminectomy procedures? * Does the subject have evidence of tumour and/or malignant disease with resultant life expectancy of less than two years? * Does the subject have known osteoporosis or severe osteopenia as determined by the Investigator? * Does the subject have rheumatoid arthritis, ankylosing spondylitis or are they immunocompromised? * Does the subject have a known allergy to the material used in the instrumentation? * Does the subject have evidence of an active infection and/or do they have any condition that would compromise their participation and follow-up in this clinical study? * Is the subject receiving any drug treatment that may affect bone metabolism? * If the subject is female, are they pregnant or lactating? * Is the subject a current smoker, or have they stopped smoking less than 6 months ago? * Is the subject a known drug or alcohol abuser or do they have a baseline opioid use greater than 30 mg of morphine equivalent/day or do they have psychological disorders that could affect follow-up care or treatment outcomes? * Is the subject currently enrolled in a clinical study?

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • OrthoCarolina Research Institute

    Charlotte, North Carolina, 28207, United States

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107, United States

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