Pediatric Orthopaedic Implant Safety & Efficacy

Summary

Implant devices are important tools - their use is essential across a number of orthopaedic indications, including hip conditions, trauma and limb deformity. Given the vital role fixation devices play in maintaining alignment, promoting healthy bone healing and preventing joint degeneration, it is essential to understand the expected lifetime outcomes of these implants, and evaluate their safety and efficacy. Prospective implant efficacy and safety registries are needed to support this endeavour, especially considering new regulatory requirements from the European Union Medical Devices Regulation (EU MDR) in relation to post-market clinical follow-up (PMCF).

Eligibility

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

Conditions12

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