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New study reviews limb lengthening surgery in kids under 12

NCT ID NCT06714110

Disease control Sponsor: NuVasive Source: ClinicalTrials.gov ↗

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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 This study
Not open to general applications. Only people the study team invites can take part.
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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 reviews past surgeries to see how safe and effective limb lengthening is for children 12 and under with a leg length difference of at least 2 cm. Researchers will look at complications, bone healing on X-rays, and patient feedback. The study includes children treated with the Precice rod system or an external fixator. The goal is to better understand outcomes and risks in this young age group.

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

Mar 2025

Expected to finish

Dec 2026

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

Pediatric (12 years and under) population

Ages

0 months to 12 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: * All potential index surgeries must meet the inclusion criteria below in order to be considered for enrollment: 1. Patient was 12 years of age or younger at the time of the index surgery. 2. Diagnosis of femoral or tibial limb length discrepancy greater than or equal to 2.0 cm. 3. Limb length discrepancy secondary to congenital or acquired etiologies. 4. Patients received limb lengthening treatment of the femur or tibia with the Precice IMLL System or an external fixator limb lengthening device. 5. Minimum medullary canal diameter ≥6 mm in the treated bone - Precice IMLL System treatment group only. 6. Closed or nonfunctioning physeal growth plates in the treated bone - Precice IMLL System treatment group only. 7. Minimum of 12 months of follow-up. 8. Available medical and radiographic records preoperatively through consolidation. Exclusion Criteria: * Index surgeries will be excluded from consideration for the study if they meet any of the following criteria: 1. Patients with unresolved limb lengthening-related adjacent joint contractures (loss of range of motion), subluxation, or dislocation prior to the index surgical procedure. 2. Patients with uncorrected coronal or sagittal plane angular malalignment following the index surgical procedure. 3. Patients with unresolved complications related to previous limb lengthening on the index or different limbs, including unhealed pin sites and/or residual bone infection (from external fixator devices) on the index limb. 4. Patients with femoral head osteonecrosis from a previous implantation of a femoral nail prior to the index surgical procedure. 5. Patients with a previous implantation of a femoral or tibial nail across an open physeal growth plate prior to the index surgical procedure.

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As listed by the trial registrant

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

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

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  3. A doctor treating you

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Contacts and locations

Locations

  • Paley Institute

    West Palm Beach, Florida, 33407, United States

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