A Study of Precice Intramedullary Limb Lengthening System (IMLL) Limb Lengthening Procedures

• Conditions: Limb Length Discrepancy

• Registration Number: NCT06741514
• Lead Sponsor: NuVasive

Brief Summary

The Sponsor is conducting a survey to understand how parents or legal guardians feel about the benefits of using the Precice IMLL System to lengthen limbs in children who are 12 years old or younger.

Detailed Description

All participants in this survey study will be the parent or legal guardian of a child who previously underwent surgery for limb length discrepancy according to the practitioner's standard of care, was 12 years of age or younger at the time of surgery, and is enrolled in the Precice IMLL arm in protocol NUVA.IMLL0723. The parent or legal guardian will be familiar with the patient's preoperative and postoperative condition, surgical treatment, postoperative care, and clinical outcomes.

Each parent or legal guardian will complete the perceived clinical benefits survey questionnaire once. The survey will be administered as either a paper-based questionnaire via mail or over the phone or an electronic questionnaire completed via a secure online application.

Study Timeline

• Study Start: 2024-03-25
• Study First Submitted: 2024-11-07
• Status Verified: 2024-12
• Study First Submitted QC: 2024-12-18
• Last Update Submitted: 2024-12-18
• Study First Posted: 2024-12-19
• Last Update Posted: 2024-12-19
• Primary Completion: 2025-03-01
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• To be eligible for inclusion in this perceived clinical benefit survey study, the following inclusion criteria must be met:

  1. Participants must be a parent or legal guardian of a subject already enrolled in the Precice IMLL arm of the study, "A Retrospective Review of the Clinical and Radiographic Outcomes Following the Use of the Precice Intramedullary Limb Lengthening System (IMLL) in Pediatric Limb Lengthening Procedures" (NUVA.IMLL0723).
  2. The parent or legal guardian must be familiar with the patient's preoperative and postoperative condition, surgical treatment, postoperative care, and clinical outcomes.
  3. Informed consent from the parent or legal guardian of the patient is required for participation.

Exclusion Criteria

• There are no exclusion criteria.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Perceived clinical benefits of the Precice Intramedullary Limb Lengthening (IMLL) Survey System	1 year post-op	Non-validated survey to assess the perceived clinical benefits of the Precice Intramedullary Limb Lengthening (IMLL) System in limb lengthening procedures in pediatric patients ages 12 years and younger as reported by parents or legal guardians.

Trial Locations

Locations (1)

Nationwide Childrens Hospital; 🇺🇸 Columbus, Ohio, United States