New study reviews limb lengthening surgery in kids under 12
NCT ID NCT06714110
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 Hide 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Limb length discrepancy are added.
Genom att skicka in godkänner du våra Användarvillkor
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
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.
-
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
-
Paley Institute
West Palm Beach, Florida, 33407, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.