Clinical trial NCT06714110: A Review of Precice Intramedullary Limb Lengthening (IMLL) System for Limb Lengthening Procedures in Children.
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
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Limb Length Discrepancy
Keywords: Precice IMLL
external fixator
Limb length discrepancy surgery
index bone
femur
tibia
surgery
Lead sponsor: NuVasive
Sponsor class: INDUSTRY
First posted: 2024-12-03
Enrollment: 200
Sex: ALL
Minimum age (years): 0
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric (12 years and under) population

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Bone (femur or tibia) lengthening
timeFrame: At least 1 yr post-op
measure: Osteotomy Healing
timeFrame: At least 1 yr post-op
measure: Frequency of device related complications
timeFrame: Post-op through at least 1 year post-op
Secondary outcomes:
Other outcomes:
Locations:
city: West Palm Beach
country: United States
facility: Paley Institute
state: Florida
Study officials:
affiliation: Globus Medical
name: Kyle Malone
role: STUDY_DIRECTOR
References: