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Spine implant safety under review in 200 scoliosis patients

NCT ID NCT05281757

Disease control Sponsor: Aesculap AG Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study follows 200 scoliosis patients who have received the Ennovate Complex implant to see how safe and effective it is over time. Researchers will track changes in pain and quality of life using standard questionnaires. The goal is to confirm the device works well in real-world 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.

Participants

About 200 people

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

Started

Feb 2022

Expected to finish

Oct 2028

An estimate. End dates often move.

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 who are treated with the Ennovate® Complex system system in accordance with the indications given in the instructions for use: Hyper- / hypokyphosis, Hyper- / hypolordosis, Scoliosis

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

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: * Informed consent in the documentation of clinical and radiological results of patients who are minimum 18 years old * Informed consent in the documentation of clinical and radiological results of patients AND legal representative (parent) for patients who are younger than 18 * Patient's indication according to IFU * Patient is not pregnant Exclusion Criteria: * Patient's clear unability or unwillingness to participate in follow-up examinations

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Conditions

The condition(s) this trial relates to.

idiopathic scoliosis Kyphosis Scheuermann disease scoliosis swayback

As listed by the trial registrant

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

Congenital scoliosis Hyperkyphosis Hyperlordosis Idiopathic scoliosis Neuromuscular scoliosis

How to take part

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

  1. The places running it

    2 sites in 2 countries. 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 Universiti Kebangsaan Malaysia (HUKM)

    RECRUITING

    Kuala Lumpur, Malaysia

  • University Hospital Brno

    SUSPENDED

    Brno, 62500, Czechia

More trials for these conditions

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