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New study tests High-Tech scans for safer spine surgery

NCT ID NCT04134975

Knowledge-focused Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jul 17, 2026 · Updated 2 times

Summary

This study looked at whether using a special 3D scan during surgery, combined with a navigation system, helps place screws more accurately in the lower back compared to the usual X-ray method. It involved 126 adults having lumbar spine surgery. The main goal was to see if the new technique improves screw placement and reduces radiation exposure for both patients and the surgical team.

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

126 people

The number who actually took part.

Started

Oct 2018

Finished

Jun 2022

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: * Male or female subject over the age of 18 * Subject with lumbar degenerative pathology, requiring surgery with pedicle screw placement between L1 and S1, confirmed on MRI or preoperative scan * Well conducted medical treatment, at least 3 months, which did not allow pain sedation * Unprotected adult within the meaning of the law * Subject belonging to a health insurance scheme * Subject having signed their written informed consent. Exclusion Criteria: * Subject who is a minor, pregnant, parturient or breastfeeding woman * Adult subject under legal protection, guardianship or deprivation of liberty by judicial or administrative decision * Subject hospitalised without consent * Medical contraindications to surgery and anaesthesia * Contraindication of a medical nature to an MRI (pace-maker) or a scan being carried out * Subject already treated by surgery for the same vertebral levels or adjacent levels * Subject with scoliosis with a Cobb angle of more than 10°.

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Conditions

The condition(s) this trial relates to.

lumbar disk degenerative disorder

As listed by the trial registrant

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

Lumbar disc disease Surgical procedure, unspecified

Contacts and locations

Locations

  • Clairval Private Hospital

    Marseille, Paca, 13009, France

More trials for these conditions

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