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Back surgery tweak may keep new disc stable longer

NCT ID NCT04641039

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a small change in lumbar disc replacement surgery. Normally, the outer ring of the disc is removed to implant the new disc. Researchers want to see if repairing that ring helps control excess movement and reduces wear on nearby joints. 24 adults with chronic low back pain will be followed for 12 months after surgery.

What this could mean

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

Active substance
surgical procedure (repair of the disc's outer ring during lumbar disc replacement)
What this could lead to
If successful, this could lead to a surgical technique that improves long-term outcomes for people receiving lumbar disc prostheses.
What could go wrong
This is a small, early-stage study with only 24 participants, so results may not apply to everyone. The benefit of repairing the disc ring is uncertain and may not improve pain or function.

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

About 24 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2020

Expected to finish

Dec 2029

An estimate. End dates often move.

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 to 50 years

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: * Minimum age of 18 years and maximum of 50 years, given that above that age there is usually degenerative pathology of the lumbar joint facets, which can confuse the symptoms and make it difficult to interpret the results. * Pathology compatible with chronic low back pain accompanied or not by radiculopathy originating in one or a maximum of two degenerated intervertebral discs and without signs of degeneration / osteoarthritis of the lumbar joint facets. * The type of lumbar pain must be discogenic, that is, worsen in flexion and not in extension, and in loading, as well as having a truncal distribution with possible anterior radiation towards the English or genital region. * Radiological confirmation by lumbar MRI study of lumbar discopathy of one or a maximum of two lumbar levels. * Absence in simple radiology studies of signs of vertebral instability or listhesis of the levels to be treated. * Absence of response for 6 weeks to conservative, non-surgical treatment, or presence of progressive symptoms. The treatment would also be carried out despite the absence of this study and the existence of the study does not condition in any way the treatment of the patients * Not having undergone any prior treatment of the type of microdiscectomy, laminectomy or lumbar arthrodesis, although these have been carried out at different levels than those involved on this occasion * Ability of the patient to comply with the proposed monitoring program * Patient's ability to follow the postoperative care program * Granting of informed consent Exclusion Criteria: * Signs of arthropathy of the lumbar joint facets, osteoporosis, previous interventions on the lumbar spine * Deformity or instability of the lumbar spine * Lumbar canal stenosis * Previous intervention on lumbar spine * Previous lumbar spinal fracture * Mobile spondylolisthesis\> 2 mm in translation and / or more than 11 ° angular difference with respect to the adjacent level on neutral vertical or flexion-extension radiographs * Severe osteoporosis * Spinal metastasis * Metabolic bone disease that could interfere with the implant or the surgical procedure * Rheumatoid arthritis, lupus, or other autoimmune disease that affects the musculoskeletal system * Other conditions or anatomical alterations that make the treatment of the anterior approach to the lumbar spine unfeasible * Known allergy to stainless steel, titanium or their alloys * Fixed or permanent neurological deficit * Active systemic infection at any time or ongoing preventive treatment for it, infection in the surgical site, HIV or hepatitis C * Abusive drug or alcohol use * Uncontrolled seizure disorder * Psychiatric illness that could interfere with your participation in the study * Participation in a current research study or in the 3 months prior to surgery * History of malignancy or current malignancy (except non-melanoma skin cancer), unless the patient has been treated for curative purposes and no clinical signs or symptoms have been observed for at least 5 years * Obesity (Body Mass Index or BMI\> 35)

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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.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Hospital General Universitario de Valencia

    RECRUITING

    Valencia, Valencia, 46014, Spain

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