Limb Length Discrepancy
Conditions
Keywords
Precice, limb lengthening, limb lengthening discrepancy, surgery, index bone, femur, tibia, limb length
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.
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.
Interventions
DEVICEPrecice 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.
Sponsors
NuVasive
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Perceived clinical benefits of the Precice Intramedullary Limb Lengthening (IMLL) Survey System | 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. |
Countries
United States
Outcome results
None listed