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

NCT06714110 | Enrolling By Invitation

• 1 other identifier: NUVA.ILL0723
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Limb Length Discrepancy

Keywords

Precice IMLL; external fixator; Limb length discrepancy surgery; index bone; femur; tibia; surgery

Outcome Measures

Primary Outcomes (3)

• Bone (femur or tibia) lengthening

  Achievement of targeted limb length

  At least 1 yr post-op

• Osteotomy Healing

  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.

  At least 1 yr post-op

• Frequency of device related complications

  Review of investigator-reported device-related complications

  Post-op through at least 1 year post-op

Study Arms (2)

Precice IMLL System

Patients 12 years of age or younger received Precice IMLL for correction of limb length discrepancy.

Device: Intramedullary Limb Lengthening Device

External Fixator

Patients 12 years of age or younger received an external fixator for correction of limb length discrepancy.

Device: External Fixator Limb Lengthening Device

Interventions

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.

External Fixator

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.

Precice IMLL System

Eligibility Criteria

• Age: 0 Months - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Pediatric (12 years and under) population

You may qualify if:

• 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.
• Available medical and radiographic records preoperatively through consolidation.

You may not qualify if:

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

Sponsors & Collaborators

• NuVasive: lead

Study Sites (1)

Paley Institute

West Palm Beach, Florida, 33407, United States

Location

Study Officials

• Kyle Malone

  Globus Medical

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2024
• First Posted: December 3, 2024
• Study Start: March 13, 2025
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)