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).
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
Patients with a demonstrated sensitivity to metals
Patients with an inability to follow a post-operative regimen
Anyone who meets the eligibility criteria and is within the age limits listed in the above sections can participate in this study.
Cohort
Prospective
Pediatric orthopaedic implant
DevicePatient receives a pediatric orthopaedic implant as a part of standard clinical care.
Device related adverse events
Determine the frequency and severity of device-related adverse events at device-specific end points. All adverse events will be recorded and followed during the study. The frequency and severity of device related adverse events will be analyzed to ensure the device risk profile has not changed.
Implant survival
Determine the implant survival rate at post-operative end-point: (lack of revision)
Implant efficacy
Efficacy will be assessed by post-operative clinical and radiographic evaluations at each follow-up end-point to assess bone fixation and/or deformity correction.
Numeric pain rating scale (NPRS)
The numeric pain rating scale (NPRS) is a subjective, 11-point numerical scale in which respondents self-report their pain on a scale of 0 (no pain at all) to 10 (worst pain imaginable).
LIMB-Q Kids
LIMB-Q Kids is a new patient reported outcome measure (PROM) for children with lower limb deformities.
PROMIS
The Patient Reported Outcomes Measurement Information System (PROMIS) measures are self-reported and parent-reported. It includes over 300 measures of global, physical, mental, and social health for adults and children in the general population and those living with a chronic condition. Specifically, the PROMIS Global Health will be administered to all patients while the PROMIS Physical Function - Mobility short form will be administered to those with an implant used in a lower extremity and the PROMIS Physical Function - Upper Extremity short form will be administered to those with an implant used in an upper extremity.
Click on the lead sponsor to view all of their trials.
University of British Columbia
Lead sponsor
OrthoPediatrics
Collaborator
