NCT06741514

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

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

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: NuVasive · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Limb Length Discrepancy

Interventions

Type	Name	Description
DEVICE	Precice IMLL	Parents or legal guardians of children that previously received the Precice IMLL will complete a survey. No additional or new interventions will be administered.

Timeline

• Start date: 2024-03-25
• Primary completion: 2026-07-01
• Completion: 2026-12-30
• First posted: 2024-12-19
• Last updated: 2025-12-18

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study