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

NCT ID: NCT06741514

Last Updated: 2024-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-25

Study Completion Date

2025-12-30

Brief Summary

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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

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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

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Limb Length Discrepancy

Keywords

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

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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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).

Precice IMLL

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NuVasive

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Affairs Study Director

Role: STUDY_DIRECTOR

Globus Medical Inc

Locations

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Nationwide Childrens Hospital

Columbus, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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NUVA.ILL0923

Identifier Type: -

Identifier Source: org_study_id