Weight-Bearing CT Scans for Periprosthetic Fractures

Overseen By Farzan Mohammadreza, MSc

Age: 18+

Sex: Any

Trial Phase: Academic

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

Disqualifiers: Non-English speakers, Other revision surgery, Others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 visit

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to assess bone healing after knee surgery using weight-bearing CT scans, a type of imaging test. It focuses on individuals who have had a broken bone around a knee implant repaired with a plate and screws. The aim is to determine if this scan provides better information about bone healing compared to regular X-rays. The trial seeks participants who underwent revision surgery for this specific fracture more than a year ago and can stand on one leg during the scan. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance future bone healing assessments.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that weight-bearing CT is safe for assessing periprosthetic fractures?

Research has shown that weight-bearing CT scans safely assess knee healing after surgery. These scans are non-invasive, requiring no surgery or insertion into the body. No specific risks have been reported for weight-bearing CT scans; they are similar to X-rays but offer more detailed images.

Studies have found that patients with knee fractures around implants who begin weight-bearing soon after surgery do not experience more complications than those with fractures in natural knees. This finding suggests that bearing weight, a component of this study, is generally well-tolerated by patients with similar conditions.

Overall, using these CT scans in this study appears safe and does not introduce additional risks beyond those expected in standard post-surgery care. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using weight-bearing CT scans for periprosthetic fractures because this method offers a new way to assess how well the repaired knee can handle weight after surgery. Traditionally, imaging techniques like X-rays or non-weight-bearing CT scans don't show how the bones and implants perform under pressure. This new approach allows doctors to see the knee in action, potentially leading to better treatment plans and outcomes. By understanding the real-world performance of the knee post-surgery, clinicians can tailor rehabilitation and care more effectively.

What evidence suggests that weight-bearing CT is effective for assessing periprosthetic fractures?

Research has shown that weight-bearing CT scans effectively diagnose bone healing around knee implants. These scans reveal areas where bone growth might be incomplete, which regular X-rays might miss. In this trial, participants who have undergone revision surgery for periprosthetic distal knee fractures will be evaluated using weight-bearing CT scans. Studies have found that these scans provide a clearer view of fracture healing after surgery. This clarity is crucial for doctors to make better treatment decisions and improve outcomes for patients with broken bones around an implant. By assessing bone stability and healing, doctors can offer more accurate care. ^{6 7 8 9 10}

Who Is on the Research Team?

Lyndsay Somerville, PhD

Principal Investigator

London Health Sciences Centre

Patrick J Mixa, MD

Principal Investigator

Western University

James Howard, MD

Principal Investigator

London Health Sciences Centre

Matthew Teeter, PhD

Principal Investigator

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

Brent Lanting, MD

Principal Investigator

Lawson Health Sciences Centre

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Periprosthetic Fracture Knee Repaired Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

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

Lead Sponsor

Trials

678

Recruited

421,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06909916

Weight-Bearing CT and Conventional Periprosthetic Distal Knee ... The investigators will be assessing the use of weight-bearing CT and conventional CT, specifically its imaging, with RSA-like software, for analyzing fracture ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0020138323001705

Periprosthetic distal femur fractures around total knee ... Although there is a paucity of data, DFRs have demonstrated expedient weight bearing, shorter stays in hospital and similar cost effectiveness to ORIFs. A ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4092206/

Periprosthetic fractures around the knee: current concepts ... Cohort studies have demonstrated that the use of locked plate fixation achieves satisfactory rates of union (96 %) but this may take up to 6 months and require ...

4. ctv.veeva.com ctv.veeva.com/study/weight-bearing-ct-periprosthetic-distal-knee-fractures

Weight-Bearing CT Periprosthetic Distal Knee Fractures 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 ...

5. mdpi.com mdpi.com/2077-0383/13/18/5519

Trends in the Use of Weightbearing Computed Tomography Background: This review aimed to critically appraise the most recent orthopedic literature around cone beam weightbearing computed tomography (WBCT), ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6179004/

Periprosthetic knee fractures. A review of epidemiology ... Is immediate weight bearing safe for periprosthetic distal femur fractures treated by locked plating? A feasibility study in 52 consecutive patients ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0972978X24000746

Outcomes of operatively managed periprosthetic distal ... Patients with periprosthetic femur fractures have similar time to weight bearing and complications rate with patients with distal femur fracture in native knees ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5142343/

Is immediate weight bearing safe for periprosthetic distal ... Mortality rates for periprosthetic distal femur fractures have been shown to be as high as 17–46% with 30 day, 6 month and 1 year rates of 2%, ...

9. link.springer.com link.springer.com/article/10.1007/s00590-019-02582-5

Periprosthetic fractures of the knee: a comprehensive review Researchers concluded that the use of locking plates had a 96% union rate, yet complete healing took 6 months and full weight-bearing was ...

10. withpower.com withpower.com/trial/phase-fractures-bone-5-2024-a4795

Weight-Bearing CT Scans for Periprosthetic Fractures 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 ...