Weight-Bearing CT and Conventional Periprosthetic Distal Knee Fractures

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-90
SponsorLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Periprosthetic Fracture Knee Repaired CT Scans

    Other intervention

    The 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

20 Participants
are divided into 1 treatment group
Group A: Periprosthetic Fracture Knee RepairedExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
1 visit is only required for which the outcome measure will then be assessed. Through study completion, approximately of 1 year.
2

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.

Time frame
1 visit is only required for which the outcome measure will then be assessed. Through study completion, approximately of 1 year.
3

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.

Time frame
1 visit is only required for which the outcome measure will then be assessed. Through study completion, approximately of 1 year.
4

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.

Time frame
1 visit is only required for which the outcome measure will then be assessed. Through study completion, approximately of 1 year.

Secondary outcomes

Other outcomes

Sponsors and contacts

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