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NCT06714110

A Review of Precice Intramedullary Limb Lengthening (IMLL) System for Limb Lengthening Procedures in Children.

Enrolling by Invitation
Not specifiedAges 0–12Observational
NuVasive
~200 participants
Updated 2025-12-22 on ClinicalTrials.gov
What's tested:Intramedullary Limb Lengthening DeviceExternal Fixator Limb Lengthening Device

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Bone (femur or tibia) lengthening
Measured over At least 1 yr post-op
+2 more outcomes measured

Conditions

Limb Length Discrepancy

Explore related trials

Limb length discrepancy

Where it's being run

1 sites across 1 states
Florida1

Study leadership

  • Kyle Malone · STUDY_DIRECTOR · Globus Medical

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Exclusion

Index surgeries will be excluded from consideration for the study if they meet any of the following criteria:

What this trial measures

  • Bone (femur or tibia) lengtheningAt least 1 yr post-op

    Achievement of targeted limb length

  • Osteotomy HealingAt least 1 yr post-op

    Assessment of osteotomy healing using the following descriptors: * Premature healing: Defined as osteotomy healing before the target length is achieved. * Healed (consolidated): Defined as the presence of full corticalization (ossified) of regenerate bone of three of four cortices seen on AP and lateral radiographs. * Delayed union (consolidation): Defined as bone union taking greater than 6 months but with progressive improvement on radiographs and the osteotomy eventually healed. * Partial union (consolidation): Defined as incomplete bone healing, i.e., radiographic healing at only 1 or 2 cortices on AP and lateral views. * Nonunion (pseudarthrosis): Defined as lack of complete healing within 6 months of the end of the lengthening period.

  • Frequency of device related complicationsPost-op through at least 1 year post-op

    Review of investigator-reported device-related complications