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New device aims to cut spine screw errors in half

NCT ID NCT05565131

Knowledge-focused Sponsor: Centre Hospitalier Universitaire de Nīmes 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tested a new lightweight device called PYTHEAS ODYSSEE that helps surgeons place screws in the spine more accurately. Fourteen adults having spine surgery used the device to guide screw placement. The goal was to see if the device reduces screw misplacement and is safe to use.

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

14 people

The number who actually took part.

Started

Sep 2022

Finished

Mar 2023

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: * Patient with indication for posterior arthrodesis of at least 2 lumbar or thoracic vertebrae with placement of pedicle screws at vertebral level for : * Traumatology: fracture with significant vertebral compression or major kyphosis deformity, ligament and/or disc injury resulting in instability, with the need to free the marrow or nerve roots, OR * Deformity: idiopathic scoliosis with surgical indication for increased curvature, thoracic curvature greater than 45° or lumbar curvature greater than 35°, OR * Revision surgery for extension of the assembly in the presence of a possible adjacent syndrome responsible for instability and/or central or foraminal stenosis, OR * Degenerative: symptomatic spondylolisthesis, degenerative scoliotic deformity, narrow lumbar canal with canal release leading to instability, syndrome adjacent to a previously performed montage. * The patient must have given their free and informed consent and signed the consent form * The patient must be a member or beneficiary of a health insurance plan Exclusion Criteria: * Patients with contraindication to screw placement * Patients with contraindication to CT scan * Silicon allergy * The subject is participating in a category 1 interventional study, or is in a period of exclusion determined by a previous study * The patient is unable to express their consent * It is impossible to give the subject informed information * The patient is under safeguard of justice or state guardianship * Pregnant, parturient or breastfeeding

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Conditions

The condition(s) this trial relates to.

osteoarthritis, spine spinal injury vertebral column disorder

As listed by the trial registrant

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

Pedicle screw Surgical navigation systems

Contacts and locations

Locations

  • CHU de Nimes

    Nîmes, France

  • Hôpital Saint Joseph

    Marseille, France

More trials for these conditions

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