About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Single group
Treatments tested in this trial
Periprosthetic Fracture Knee Repaired CT Scans
Other interventionThe investigators will be assessing the use of weight-bearing CT and conventional CT, specifically its imaging, with RSA-like software, for analyzing fracture healing for a periprosthetic distal knee fracture.
Treatment groups
Trial outcomes
Primary outcomes
Maximum Total Point Motion of Fracture Segments from Conventional CT scans
Weight-Bearing CT scans of participants will be analyzed for any potential movement between the fracture segments from the identified fracture lines. This will be reported as the maximum total point motion, which refers to the largest observed movement of a point along the fracture line from its initial position.
Maximum Total Point Motion of Fracture Segments from Conventional CT scans
Conventional CT scans of participants will be analyzed for any potential movement between the fracture segments from the identified fracture lines. This will be reported as the maximum total point motion, which refers to the largest observed movement of a point along the fracture line from its initial position.
Western Ontario and McMaster Universities Arthritis Index (WOMAC) Questionnaire
This Pain and function questionnaire will be used to assess the pain and ability-to-function of the knee of the participant. This is a participant-reported outcome and it will be compared to the weight-bearing and conventional CT scans.
The Knee Society Score (KSS) Questionnaire
Knee function and patient outcome questionnaire that will be used to assess the pain and functionality of the knee of the participant. This is a participant-reported outcome and ut will be compared to the weight-bearing and conventional CT scans.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.