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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
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Inclusion Criteria:
To be eligible for inclusion in this perceived clinical benefit survey study, the following inclusion criteria must be met:
Exclusion Criteria:
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Parents or legal guardians of patients who were enrolled in the Precice IMLL arm of the retrospective data collection study (NUVA.IMLL0723).
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| Name | Affiliation | Role |
|---|---|---|
| Medical Affairs Study Director | Globus Medical Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Paley Orthopedic and Spine Institute | West Palm Beach | Florida | 33407 | United States | ||
| Nationwide Childrens Hospital |
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| Columbus |
| Ohio |
| 43205 |
| United States |