Pediatric Orthopaedic Implant Safety & Efficacy

Launched by UNIVERSITY OF BRITISH COLUMBIA · May 2, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at the safety and effectiveness of special implant devices used in children with various orthopedic conditions, such as bone fractures, limb deformities, and hip problems. These implants are important because they help keep bones aligned, promote healing, and prevent issues with joints. The study aims to gather information about how well these devices work and their expected lifespan, especially in light of new regulations that require ongoing monitoring of medical devices after they are used.

To be part of this trial, participants should be children who need these implants based on their doctor’s advice. They must also be able to follow the required check-up schedule after receiving the implant. Participants will need to give consent, and their parents or guardians will also need to be involved in the process. However, children with allergies to metals or those who cannot follow post-surgery care instructions will not be eligible. Overall, this trial is an important step in ensuring that these devices are safe and effective for young patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients indicated for the device-specific indication, per physician discretion and as indicated in the device IFU. Off-label use is strongly discouraged; however, any and all on- and off-label indications for use of the products in this program will be collected and stratified accordingly
• • Patients must be able to adhere to the required length of follow-up for the endpoints of each individual product
• • Informed consent/assent is required
• Exclusion Criteria:
• • Patients with a demonstrated sensitivity to metals
• • Patients with an inability to follow a post-operative regimen