21 Participants NeededMy employer runs this trial

Weight-Bearing CT for Knee Implant Fractures

BL
FM
LS
Overseen ByLyndsay Somerville, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Lawson Health Research Institute
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of 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.

Who Is on the Research Team?

BL

Brent Lanting, MD

Principal Investigator

London Health Sciences Centre

LS

Lyndsay Somerville, PhD

Principal Investigator

London Health Sciences Centre

JH

James Howard, MD

Principal Investigator

London Health Sciences Centre

MT

Matthew Teeter, PhD

Principal Investigator

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

Are You a Good Fit for This Trial?

This trial is for people aged 50-90 with a BMI up to 40 who recently (within one week) had surgery to repair a broken bone above their knee implant using plates and screws. Participants must be able to give consent and follow study instructions.

Inclusion Criteria

Body mass index up to 40kg/m2
Able to provide informed consent
I am able and willing to follow study instructions and complete assessments.
See 2 more

Exclusion Criteria

I cannot stand on one leg during the CT scan test.
Does not understand English
I have had revision surgery on my affected knee.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo revision surgery for periprosthetic distal knee fracture and receive weight-bearing CT scans

1 week
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including pain and function questionnaires and CT scans

1 year
Multiple visits (in-person)

Microbiome Analysis

Stool samples collected and analyzed to assess gut microbiome composition related to bone healing

6 weeks

What Are the Treatments Tested in This Trial?

Trial Overview

The study tests if weight-bearing CT scans (scans taken while standing or putting weight on the leg) can better assess healing of fractures around knee implants after revision surgery, compared to standard imaging methods.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Periprosthetic Fracture Knee RepairedExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Lawson Health Research Institute

Lead Sponsor

Trials
684
Recruited
432,000+

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

Lead Sponsor

Trials
678
Recruited
421,000+

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

Lead Sponsor

Trials
668
Recruited
424,000+

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

Lead Sponsor

Trials
686
Recruited
427,000+