A Review of Precice Intramedullary Limb Lengthening (IMLL) System for Limb Lengthening Procedures… (NCT06714110) | Clinical Trial Compass
By InvitationNot Applicable
A Review of Precice Intramedullary Limb Lengthening (IMLL) System for Limb Lengthening Procedures in Children.
United States200 participantsStarted 2025-03-13
Plain-language summary
This study will look at how safe and effective limb lengthening surgeries are for the femur and tibia in children 12 years old and younger. We will examine any complications from the surgery, the results of X-rays, and feedback from patients. The study will involve the Precice Intramedullary Limb Lengthening (IMLL) System and external fixator devices for limb lengthening.
Who can participate
Age range
0 Months – 12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patient was 12 years of age or younger at the time of the index surgery.
. Diagnosis of femoral or tibial limb length discrepancy greater than or equal to 2.0 cm.
. Limb length discrepancy secondary to congenital or acquired etiologies.
. Patients received limb lengthening treatment of the femur or tibia with the Precice IMLL System or an external fixator limb lengthening device.
. Minimum medullary canal diameter ≥6 mm in the treated bone - Precice IMLL System treatment group only.
. Closed or nonfunctioning physeal growth plates in the treated bone - Precice IMLL System treatment group only.
. Minimum of 12 months of follow-up.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Bone (femur or tibia) lengthening
Timeframe: At least 1 yr post-op
2
Osteotomy Healing
Timeframe: At least 1 yr post-op
3
Frequency of device related complications
Timeframe: Post-op through at least 1 year post-op
. Available medical and radiographic records preoperatively through consolidation.
Exclusion criteria
. Patients with unresolved limb lengthening-related adjacent joint contractures (loss of range of motion), subluxation, or dislocation prior to the index surgical procedure.
. Patients with uncorrected coronal or sagittal plane angular malalignment following the index surgical procedure.
. 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.
. Patients with femoral head osteonecrosis from a previous implantation of a femoral nail prior to the index surgical procedure.
. Patients with a previous implantation of a femoral or tibial nail across an open physeal growth plate prior to the index surgical procedure.