About this trial
Total knee arthroplasty (TKA), a knee implant surgery, is a treatment for end-stage knee osteoarthritis. In some cases, patients suffer an associated periprosthetic fracture, a broken bone that occurs around the implant of a TKA, they may not receive excellent care due to a lack of a trustworthy assessments for fracture healing in the research world. The prevalence of TKA surgeries is increasing annually and is expected to increase 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 important to set a standard for fracture stabilization and bone healing assessments to lessen revision burdens and improve patient outcomes. CT imaging is the main clinical tool to evaluate implant stabilization in TKA, which can effectively visualize areas of incomplete bone ingrowth, bone growing into the implant, that may be hidden from overlapping bone and muscle tissue on plain x-rays. The purpose of this prospective study is to examine the efficacy of weight-bearing CT as a diagnostic tool for 21 participants who experienced a distal femur periprosthetic fracture and have underwent revision surgery using a fracture fixation plate and screws, internal splints that hold the bone pieces together. Participants will be scanned under loaded (applying weight on limb) and unloaded conditions. Radiographic outcomes, x-ray imaging from the weight-bearing CT, will be evaluated, including any movement of the bone segments and how they would relate to participants' reports of pain.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Recently underwent revision surgery for repair of a distal femur fracture surgery for total knee arthroplasty femoral component using a fracture fixation plate. Due to the study requiring the potential participant to be scanned <1-week post-operation, the duration of "recently" will be defined as <1 week post-operation.
Age 50-90 years
Body mass index up to 40kg/m2
Able to provide informed consent
Disqualifiers
Prior revision surgery on the targeted knee
Does not understand English
Undergoing and/or have undergone revision surgery for any other indication
Received intramedullary nail or distal femur replacement
Trial design
Single group
Treatments tested in this trial
Periprosthetic Fracture Knee Repaired CT Scans
Other interventionWe will be assessing the use of weight-bearing CT, specifically its imaging, with RSA-like software, for analyzing fracture healing over time for a periprosthetic distal knee fracture.
Treatment groups
Trial outcomes
Primary outcomes
Weight-Bearing CT Scans
Weight-bearing CT scans of the periprosthetic distal knee fracture that has undergone revision surgery
Pain and Function Questionnaires
Pain and function questionnaires that assess the pain and ability-to-function of the knee. These are participant-reported outcomes and they will be compared to the CT scans
Secondary outcomes
Stool sample
Stool sample collected from participant and analyzed and compared to CT scans for bone healing assessments.
Sponsors and contacts
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