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

• Conditions: Limb Length Discrepancy

• Registration Number: NCT06714110
• Lead Sponsor: NuVasive

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.

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.

Study Timeline

• Study First Submitted: 2024-11-07
• Status Verified: 2024-12
• Study Start: 2024-12-01
• Study First Submitted QC: 2024-12-02
• Last Update Submitted: 2024-12-02
• Study First Posted: 2024-12-03
• Last Update Posted: 2024-12-03
• Primary Completion: 2024-12-31
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Bone (femur or tibia) lengthening	At least 1 yr post-op	Achievement of targeted limb length
Osteotomy Healing	At least 1 yr post-op	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.
Frequency of device related complications	Post-op through at least 1 year post-op	Review of investigator-reported device-related complications

Trial Locations

Locations (1)

Paley Institute; 🇺🇸 West Palm Beach, Florida, United States