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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Limb Length Discrepancy
• Intervention / Treatment: Device: Precice IMLL

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 Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

Study Locations

• United States
  • Florida
    • West Palm Beach, Florida, United States, 33407
      • Paley Orthopedic and Spine Institute
  • Ohio
    • Columbus, Ohio, United States, 43205
      • Nationwide Childrens Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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).

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Parents or legal guardians of children that previously received the Precice IMLL will complete a survey. No additional or new interventions will be administered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: NuVasive
• Investigators: Study Director: Medical Affairs Study Director, Globus Medical Inc

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: November 7, 2024
• First Submitted That Met QC Criteria: December 18, 2024
• First Posted (Actual): December 19, 2024

Study Record Updates

• Last Update Posted (Actual): December 18, 2025
• Last Update Submitted That Met QC Criteria: December 16, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: surgery; tibia; femur; limb lengthening; index bone; Precice; limb lengthening discrepancy; limb length
• Other Study ID Numbers: NUVA.ILL0923

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No