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

NuVasive

Status

Invitation-only

Conditions

Limb Length Discrepancy

Treatments

Device: Intramedullary Limb Lengthening Device

Device: External Fixator Limb Lengthening Device

Study type

Observational

Funder types

Industry

Identifiers

NCT06714110

NUVA.ILL0723

Details and patient eligibility

About

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.

Full 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.

Enrollment

200 estimated patients

Sex

All

Ages

Under 12 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

All potential index surgeries must meet the inclusion criteria below in order to be considered for enrollment:
1. Patient was 12 years of age or younger at the time of the index surgery.
2. Diagnosis of femoral or tibial limb length discrepancy greater than or equal to 2.0 cm.
3. Limb length discrepancy secondary to congenital or acquired etiologies.
4. Patients received limb lengthening treatment of the femur or tibia with the Precice IMLL System or an external fixator limb lengthening device.
5. Minimum medullary canal diameter ≥6 mm in the treated bone - Precice IMLL System treatment group only.
6. Closed or nonfunctioning physeal growth plates in the treated bone - Precice IMLL System treatment group only.
7. Minimum of 12 months of follow-up.
8. 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:
1. Patients with unresolved limb lengthening-related adjacent joint contractures (loss of range of motion), subluxation, or dislocation prior to the index surgical procedure.
2. Patients with uncorrected coronal or sagittal plane angular malalignment following the index surgical procedure.
3. 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.
4. Patients with femoral head osteonecrosis from a previous implantation of a femoral nail prior to the index surgical procedure.
5. Patients with a previous implantation of a femoral or tibial nail across an open physeal growth plate prior to the index surgical procedure.