Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05361980 |
| Other study ID # |
H21-03076 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 6, 2022 |
| Est. completion date |
December 2027 |
Study information
| Verified date |
May 2023 |
| Source |
University of British Columbia |
| Contact |
Emily Schaeffer, PhD |
| Phone |
604-875-2359 |
| Email |
emily.schaeffer[@]cw.bc.ca |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial 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).
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
