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NCT06525610From ClinicalTrials.govRecruiting

Weight-Bearing CT Periprosthetic Distal Knee Fractures

Assessment of Bone Displacement Under Loading Following Periprosthetic Fracture Repair With Weight-Bearing CT

  • Periprosthetic Fracture Around Prosthetic Joint Implant Knee

At a glance

Phase
Phase not stated
Study type
Interventional
Sponsor
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Enrolment target
21
Started
24 September 2025
Main results due
August 2027
Study sites
1
Registry updated
29 September 2026

Can you take part?

  • Ages 50 years to 90 years.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria
Inclusion Criteria:

* 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
* Able and willing to do study assessments and follow instructions

Exclusion Criteria:

* 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
* Cannot independently stand on one leg in the weight-bearing CT during the inducible displacement exam

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(1)

  • London Health Sciences Centre Research Institute

    London, Ontario, Canada

    Recruiting

Showing 1 of 1 sites. 1 of the 1 site on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT06525610. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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Weight-Bearing CT Periprosthetic Distal Knee Fractures | Trialion