IS&E: Pediatric Orthopaedic Implant Safety & Efficacy
Study Details
Study Description
Brief 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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
STUDY PROCEDURES Screening Patients will be screened against basic inclusion/exclusion criteria to see if patients may be appropriate for study participation according to any standard of care assessments available, and where appropriate with the site's REB/IRB screening procedures and local regulatory requirements. If a patient is deemed eligible, data outlined throughout this protocol will be collected, de-identified and entered into a Research Electronic Database Capture (REDCap) system managed at BCCH.
Enrollment Patients will be assigned a sequential, unique study number (subject ID) and de-identified data will be entered in the study database. The center number is designated by the BCCH team for each individual investigational site. The patient number will be in sequential order by the patient screening date starting with 001. Once a patient has been assigned a subject ID, the number will not be reused.
Pre-Operative Procedures Once a patient is identified as eligible for an Implant Safety and Efficacy device report, it will be determined whether that patient is already enrolled in one of the existing condition-specific registries. Should participants be enrolled in a condition-specific registry, demographic data, medical history, preoperative clinical data, including any pre-existing infections at or near the operative site, and data on pre-operative radiographs for the relevant underlying diagnosis will have already been prospectively collected under registry procedures. If a patient has not been previously enrolled in a condition-specific registry, the patient will be offered enrollment in both the condition registry and for the purposes of the Implant Safety and Efficacy device report. Demographic data, medical history, preoperative clinical data and data on pre-operative radiographs for the relevant underlying diagnosis will then be collected retrospectively from the medical record.
Required Data Collection:
Operative details in the source documentation will be collected that provide specific information from the subject's surgery such as surgical approach, complications, and unique device identification (UDI) numbers for the implanted device.
The following data will be collected and entered into the registry:
-
Operative data, specific to the technique related to the relevant OrthoPediatrics system/device
-
Assessments of any device-related adverse events
-
Assessment for other adverse events
-
When possible, the UDI number for the device(s) implanted, or information on the device implanted
Follow-up Procedures
Data collected during routine standard of care follow-up visits will be collected as part of this study. The following data will be collected:
-
Radiographs obtained during study clinical evaluations to determine bony union, as well as healing or complications
-
Device-related adverse events
-
Unanticipated device-related serious adverse device effects
-
Information on implant removals not related to an adverse event; degree of bony union just prior to implant removal Unscheduled Visits [if or when needed]
The condition-specific registries are designed to capture every visit that occurs, whether scheduled or unscheduled. An unscheduled visit may occur when an adverse event occurs, or when a patient returns outside of the planned interval window. If an unscheduled visit occurs, the following assessments are to be done:
-
Assessment of any adverse events related to the device
-
Survivorship of the device
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Longitudinal Observational Group Pediatric patients indicated for the device-specific indication, per physician discretion and as indicated in the device IFU. |
Device: Pediatric orthopaedic implant
Patient receives a pediatric orthopaedic implant as a part of standard clinical care.
|
Outcome Measures
Primary Outcome Measures
- Device related adverse events [2 years post implant insertion]
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 [2 years post implant insertion]
Determine the implant survival rate at post-operative end-point: (lack of revision)
- Implant efficacy [2 years post implant insertion]
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.
Secondary Outcome Measures
- Pediatric Outcomes Data Collection Instrument (PODCI) [2 years post implant insertion]
PODCI - The Pediatric Outcomes Data Collection Instrument (PODCI) was developed by the Pediatric Orthopaedic Society of North America (POSNA) to assess functional health status in children with musculoskeletal disorders. This validated tool consists of seven domains (upper extremity function, transfers and mobility, physical function and sports, comfort, happiness, satisfaction and expectations) and was designed for self-report (adolescents) or parent-report (children or adolescents). Both self-report and parent-report versions will be administered.
- Numeric pain rating scale (NPRS) [2 years post implant insertion]
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 [2 years post implant insertion]
LIMB-Q Kids is a new patient reported outcome measure (PROM) for children with lower limb deformities.
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | BC Children's Hospital | Vancouver | British Columbia | Canada | V6H 3N1 |
Sponsors and Collaborators
- University of British Columbia
- OrthoPediatrics
Investigators
- Study Director: Emily Schaeffer, PhD, University of British Columbia
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- H21-03076