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

NCT06741514 | Enrolling By Invitation FDA Device

• 1 other identifier: NUVA.ILL0923
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

Limb Length Discrepancy

Keywords

Precice; limb lengthening; limb lengthening discrepancy; surgery; index bone; femur; tibia; limb length

Outcome Measures

Primary Outcomes (1)

• Perceived clinical benefits of the Precice Intramedullary Limb Lengthening (IMLL) Survey System

  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.

  1 year post-op

Study Arms (1)

Parents or Legal Gaurdians

Parents or legal guardians of patients who were enrolled in the Precice IMLL arm of the retrospective data collection study (NUVA.IMLL0723).

Device: Precice IMLL

Interventions

Precice IMLL DEVICE

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

Parents or Legal Gaurdians

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Parents or legal guardians of patients who were enrolled in the Precice IMLL arm of the retrospective data collection study (NUVA.IMLL0723).

You may qualify if:

• 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).
• The parent or legal guardian must be familiar with the patient's preoperative and postoperative condition, surgical treatment, postoperative care, and clinical outcomes.
• Informed consent from the parent or legal guardian of the patient is required for participation.

Sponsors & Collaborators

• NuVasive: lead

Study Sites (2)

Paley Orthopedic and Spine Institute

West Palm Beach, Florida, 33407, United States

Location

Nationwide Childrens Hospital

Columbus, Ohio, 43205, United States

Location

Study Officials

• Medical Affairs Study Director

  Globus Medical Inc

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2024
• First Posted: December 19, 2024
• Study Start: March 25, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)