A Study of Precice Intramedullary Limb Lengthening System (IMLL) Limb Lengthening Procedures
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Precice IMLL.
- Who it may be relevant to
- Registry conditions: Limb Length Discrepancy. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Clinical Benefits Survey Study of Precice Intramedullary Limb Lengthening System (IMLL) Limb Lengthening Procedures
Overview
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
- 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.
Primary outcome measures
- Perceived clinical benefits of the Precice Intramedullary Limb Lengthening (IMLL) Survey System [Time frame: 1 year post-op]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
United States · 2 centers
- Paley Orthopedic and Spine Institute — West Palm Beach
- Nationwide Childrens Hospital — Columbus
Identifiers
NCT: NCT06741514 · NUVA.ILL0923