Clinical trial · Observational
Pediatric Orthopaedic Implant Safety & Efficacy
Global Pediatric Orthopaedic Implant Safety & Efficacy Clinical Follow-up Program
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (11)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Deformity; Bone | — | UNRESOLVED | — |
| Deformity of Limb | — | UNRESOLVED | — |
| Fracture | — | UNRESOLVED | — |
| Hip Disease | — | UNRESOLVED | — |
| Hip Dislocation | — | UNRESOLVED | — |
| Hip Dysplasia | — | UNRESOLVED | — |
| Implant Breakage | — | UNRESOLVED | — |
| Implant Complication | — | UNRESOLVED | — |
| Lengthening; Leg | — | UNRESOLVED | — |
| Orthopedic Disorder | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pediatric orthopaedic implant | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Longitudinal Observational Group
- description
- Pediatric patients indicated for the device-specific indication, per physician discretion and as indicated in the device IFU.
- interventionNames
- Device: Pediatric orthopaedic implant
Primary outcomes (3)
- measure
- Device related adverse events
- timeFrame
- 2 years post implant insertion
- description
- 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.
- measure
- Implant survival
- timeFrame
- 2 years post implant insertion
- description
- Determine the implant survival rate at post-operative end-point: (lack of revision)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 0 Years
- Maximum age
- 25 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available