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Spinal implants pass 24-Month safety check in 77 patients

NCT ID NCT04670536

Disease control Sponsor: Medicrea International 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 followed 77 adults who received spinal implants (PASS LP, PASS DEGEN, or PASS TULIP PRIME) to treat degenerative spine conditions like disc degeneration or spinal deformity. The main goal was to see if the bones fused properly after 24 months. Researchers also tracked pain and quality of life changes. The study is already completed and supports the implants' safety and effectiveness for medium-term use.

What this could mean

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

Active substance
PASS LP, PASS DEGEN, and PASS TULIP PRIME spinal implants
What this could lead to
If successful, this could confirm that these implants are safe and effective for fusing spine bones in people with degenerative spine disease.
What could go wrong
This is a small, completed post-market study with no control group, so results may not apply to everyone. Fusion may fail or complications could occur.

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.

Participants

77 people

The number who actually took part.

Started

May 2018

Finished

May 2024

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.

Who is studied

All patients

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: * Patients of at least 18 years old * Patient suffering from a spinal degenerative disease. * Patient requiring spinal surgery for less than 4 levels for a spinal degenerative disease * Patient implanted with MEDICREA's products, or patients who are candidate to receive including at least the PASS LP and/or PASS DEGEN and/or PASS TULIP Prime implants * Patient affiliated to a national insurance system Exclusion Criteria: * Patient unable or unwilling to sign and understand an information note with proof of patient consent * Patient unable to complete a self-administered questionnaire * Patient presenting contra-indications to a Xray follow-up * Patient of more than 18 years old under a protection procedure * Patient judged as non-compliant by the investigator or not able to come back for follow-up visits up to 2 years

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Conditions

The condition(s) this trial relates to.

spondylolisthesis spondylosis thoracic disk degenerative disorder vertebral column disorder

As listed by the trial registrant

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

Spinal deformity Spinal degeneration Thoracolumbar disc degeneration Thoracolumbar spondylolisthesis

Contacts and locations

Locations

  • CHRU Tours, Hôpital de Bretonneau

    Tours, 37044, France

  • Clinique des Cèdres

    Cornebarrieu, 31700, France

  • Clinique du Dos Bordeaux - Terrefort

    Bruges, 33520, France

  • Hôpital Pitié-Salpêtrière AP-HP

    Paris, Île-de-France Region, 75651, France

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