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

Conditions

• Limb Length Discrepancy

Eligibility Criteria

Sex

ALL

Age

0 Months - 12 Years

Healthy Volunteers

Not accepted

Interventions

• Intramedullary Limb Lengthening Device — 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.
• External Fixator Limb Lengthening Device — 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.

Study Details

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.

Key Dates

Start date

Mar 13, 2025

Status verified

Dec 2025

Primary completion

Jul 30, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

200 participants (estimated)

Arms

• Arm: Precice IMLL System
  Patients 12 years of age or younger received Precice IMLL for correction of limb length discrepancy.
• Arm: External Fixator
  Patients 12 years of age or younger received an external fixator for correction of limb length discrepancy.

Primary Outcome Measure

Bone (femur or tibia) lengthening [ Time Frame: At least 1 yr post-op ]

Locations (1)

Find similar trials in West Palm Beach, FL

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