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New spine surgery aims to straighten scoliosis in teens

NCT ID NCT06396286

Disease control Sponsor: Istituto Ortopedico Rizzoli 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests a spine surgery for 20 teenagers (ages 12-21) with a specific type of scoliosis called Lenke 1. The goal is to correct the spine curve and improve quality of life. Researchers will measure how well the surgery works using X-rays and patient questionnaires.

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

20 people

The number who actually took part.

Started

Jun 2024

Expected to finish

Sep 2026

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

12 to 21 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: * Diagnosis of AIS; * Male and female sex; * Age between 12 and 21; * Thoracic scoliotic curve, type I according to Lenke's classification; * Preoperative radiographic range of the main scoliotic curve between 40° and 70° Cobb; * Reducibility of the curve on bending radiographs by 30%; * Signature of the informed consent of patients/parents to actively participate in the study and clinical follow-up. EXCLUSION CRITERIA: * Scoliosis with an etiology different from AIS; * pre-operative COBB \> 70°; * Patients already treated surgically for scoliosis; * Location of the scoliotic curve: Lenke 2-6; * Patients who do not fall within the parameters described; * Patients unable to express consent or carry out follow-ups; * Language barrier; * Pregnant women.

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Conditions

The condition(s) this trial relates to.

adolescent idiopathic scoliosis scoliosis vertebral column disorder

As listed by the trial registrant

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

Adolescent idiopathic scoliosis Scoliosis Spine deformity

Contacts and locations

Locations

  • Istituto Ortopedico Rizzoli

    Bologna, 40136, Italy

More trials for these conditions

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