20 Participants Needed

Weight-Bearing CT Scans for Periprosthetic Fractures

BL
FM
Overseen ByFarzan Mohammadreza, MSc
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of 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.

Research Team

MT

Matthew Teeter, PhD

Principal Investigator

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

BL

Brent Lanting, MD

Principal Investigator

Lawson Health Sciences Centre

LS

Lyndsay Somerville, PhD

Principal Investigator

London Health Sciences Centre

PJ

Patrick J Mixa, MD

Principal Investigator

Western University

JH

James Howard, MD

Principal Investigator

London Health Sciences Centre

Eligibility Criteria

This trial is for individuals who have had a total knee replacement and later suffered from a periprosthetic fracture near the implant. Participants should be those who underwent revision surgery with fixation plates and screws, willing to undergo CT scans under different conditions.

Inclusion Criteria

Body mass index up to 40kg/m2
Able to provide informed consent
I am between 50 and 90 years old.
See 2 more

Exclusion Criteria

I have had surgery to correct a previous procedure.
I do not understand English.
I have had surgery involving a metal rod in my bone or knee replacement.
See 1 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo weight-bearing and conventional CT scans to assess bone displacement under loading conditions

1 visit
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after CT scans, with outcome measures assessed through questionnaires

1 year

Treatment Details

Interventions

  • Weight-Bearing CT
Trial Overview The study aims to test the effectiveness of weight-bearing CT as a diagnostic tool compared to standard imaging techniques. It will involve 20 participants who will receive CT scans while bearing weight and without, to assess bone healing after fracture repair surgery.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Periprosthetic Fracture Knee RepairedExperimental Treatment1 Intervention
The one and only group will be participants that have undergone revision surgery for at least 1\> year prior for their periprosthetic distal knee fracture.

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Who Is Running the Clinical Trial?

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Lead Sponsor

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Recruited
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