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Enrolling by invitation NCT06714110

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

— Observational Limb Length Discrepancy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Intramedullary Limb Lengthening Device, External Fixator Limb Lengthening Device.
Who it may be relevant to
Registry conditions: Limb Length Discrepancy. Basic parameters: 0 months — 12 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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.

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

Primary outcome measures

  • Bone (femur or tibia) lengthening [Time frame: At least 1 yr post-op]
  • Osteotomy Healing [Time frame: At least 1 yr post-op]
  • Frequency of device related complications [Time frame: Post-op through at least 1 year post-op]

Eligibility criteria

Inclusion criteria

  • All potential index surgeries must meet the inclusion criteria below in order to be considered for enrollment:
  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Paley Institute — West Palm Beach

Identifiers

NCT: NCT06714110 · NUVA.ILL0723

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗