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ENROLLING BY INVITATION
NCT06714110

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

Sponsor: NuVasive

View on ClinicalTrials.gov

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.

Official title: A Retrospective Review of Clinical and Radiographic Outcomes Following the Use of the Precice Intramedullary Limb Lengthening (IMLL) System in Pediatric Limb Lengthening Procedures

Key Details

Gender

All

Age Range

0 Months - 12 Years

Study Type

OBSERVATIONAL

Enrollment

200

Start Date

2025-03-13

Completion Date

2026-12

Last Updated

2025-12-22

Healthy Volunteers

No

Interventions

DEVICE

Intramedullary Limb Lengthening Device

The Precice IMLL System is composed of the Precice nail, screws, and uses an external remote controller (ERC) for rod distraction. The Precice IMLL System is designed to fit the anatomy of long bones and is intended to be placed internally in an intramedullary manner. It achieves limb correction through gradual lengthening or compression and providing intramedullary fixation for fractures of long bones.

DEVICE

External Fixator Limb Lengthening Device

External fixator devices consist of an external frame (ring, half-ring, monolateral, and rail); bone fixation is accomplished by the transcutaneous bone fixations implants (pins, wires, cables, screws), and the lengthening is accomplished by the vertical components (struts). Generally, femoral lengthening devices are monolateral and tibial lengthening devices have ring or half-ring frames. The external fixators are made of a variety of materials, including stainless steel, titanium, carbon fiber, and aluminum.

Locations (1)

Paley Institute

West Palm Beach, Florida, United States