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OpenTrials
Enrolling by Invitation

NCT Number: NCT06741514

A 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.

Enrolling by Invitation

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Paley Orthopedic and Spine Institute, West Palm Beach, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • There are no exclusion criteria.

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

NuVasive

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Dec 19, 2024
Registry last updated
Dec 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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