NCT06909916 Weight-Bearing CT and Conventional Periprosthetic Distal Knee Fractures
| NCT ID | NCT06909916 |
| Status | Recruiting |
| Phase | — |
| Sponsor | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's |
| Condition | Periprosthetic Fracture Around Prosthetic Joint Implant |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2024-06-20 |
| Primary Completion | 2025-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2024-06-20 with a primary completion date of 2025-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Total knee arthroplasty (TKA) is a surgical procedure commonly conducted for patients with end-stage knee osteoarthritis, often leading to improved pain relief and function. However, for patients that have suffered an associated periprosthetic fracture, a broken bone that occurs around the implant of a TKA, they may receive sub-optical care due to a lack of a trustworthy assessments for component fixation and fracture healing in the literature. The prevalence of TKA surgeries is increasing annually and is projected to rise further due to an ageing population and obesity issue. By extension to this primary surgery, more Canadians will require an invasive revision surgery that risks patient morbidity and mortality. Thus, it is imperative to set a standard for fixation and bone healing assessments to lessen revision burdens and improve patient outcomes. CT imaging can effectively visualize areas of incomplete bone ingrowth that may be hidden from overlapping anatomy on plain radiographs, which remains the go-to imaging modality for orthopaedic surgeons to assess periprosthetic fracture healing. The purpose of this prospective cross-sectional study is to examine the efficacy of weight-bearing CT as a diagnostic tool for 20 participants who experienced a distal femur periprosthetic fracture and underwent revision surgery using a fracture fixation plate and screws. Participants will be scanned under loaded and unloaded conditions. Radiographic outcomes will be evaluated, including bone segment displacement and its relation to participants' reports of pain.
Eligibility Criteria
Inclusion Criteria: * Underwent revision surgery for repair of a distal femur fracture surrounding a primary TKA femoral component using a fracture fixation plate \>1 year * Age 50-90 years * Body mass index up to 40kg/m2 * Able to provide informed consent * Able and willing to do study assessments and follow instructions Exclusion Criteria: * Does not understand English * Undergone revision surgery for any other indication * Received Intramedullary nail or distal femur replacement * Cannot independently stand on one leg in the weight-bearing CT during the inducible displacement exam
Contact & Investigator
Matthew Teeter, PhD
STUDY DIRECTOR
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Frequently Asked Questions
Who can join the NCT06909916 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, up to 90 Years, studying Periprosthetic Fracture Around Prosthetic Joint Implant. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06909916 currently recruiting?
Yes, NCT06909916 is actively recruiting participants. Contact the research team at brent.lanting@lhsc.on.ca for enrollment information.
Where is the NCT06909916 trial being conducted?
This trial is being conducted at London, Canada.
Who is sponsoring the NCT06909916 clinical trial?
NCT06909916 is sponsored by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's. The principal investigator is Matthew Teeter, PhD at London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's. The trial plans to enroll 20 participants.