Recruiting

Weight-Bearing CT

Sponsor:

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

Code:

NCT06525610

Conditions

Periprosthetic Fracture Around Prosthetic Joint Implant Knee

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Interventions

Periprosthetic Fracture Knee Repaired CT Scans

Study Details

Brief summary:

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.

Conditions

Periprosthetic Fracture Around Prosthetic Joint Implant Knee

Study ID

NCT06525610

Start date

Sep 24, 2025

Status verified date

Sep, 2026

Completion date

Aug, 2027

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

21 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Periprosthetic Fracture Knee Repaired

The one and only group will be participants that have recently undergone revision surgery for their periprosthetic distal knee fracture.

Interventions

Periprosthetic Fracture Knee Repaired CT Scans

We will be assessing the use of weight-bearing CT, specifically its imaging, with RSA-like software, for analyzing fracture healing over time for a periprosthetic distal knee fracture.

Primary outcome measure

  • Weight-Bearing CT Scans [ Time Frame: Scans obtained: <1-week post-operation, 6-weeks, and 1-year ]
  • Pain and Function Questionnaires [ Time Frame: <1-week post-operation, 6 weeks, and 1-year ]

Central Contacts and Locations

Central contacts

Locations

London Health Sciences Centre Research Institute

Recruiting

London, Ontario, Canada, N6A5A5

Contacts

Principal Investigator:

Brent Lanting

More Information

Sponsor

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

Last update posted

Sep 17, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-18. This information was provided to ClinicalTrials.gov by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's on 2026-09-17.