NCT06714110

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

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

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: NuVasive · Industry
• Sex: All
• Age: 0 Months – 12 Years
• Healthy volunteers: Not accepted

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.

Detailed description

As a retrospective chart review, all patients involved in this study will have undergone surgery for their limb length discrepancy according to the standard of care of the practitioner using either the Precice IMLL or an external fixator. Under this protocol, available patient outcomes, plain radiographs, and complications will be obtained from the existing medical records of all eligible index surgeries. An index surgery is defined as the first limb lengthening surgery performed by a study investigator on the index bone with either the Precice IMLL or an external fixator. Each patient may have up to 4 eligible index surgeries (right and left femur, right and left tibia) and be included in both the Precice IMLL and external fixator groups.

Conditions

• Limb Length Discrepancy

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-03-13
• Primary completion: 2026-07-30
• Completion: 2026-12-01
• First posted: 2024-12-03
• Last updated: 2025-12-22

Locations

1 site across 1 country: United States