Recruiting

Observational Study

Sponsor:

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

Code:

NCT06909916

Conditions

Periprosthetic Fracture Around Prosthetic Joint Implant

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) 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.

Conditions

Periprosthetic Fracture Around Prosthetic Joint Implant

Study ID

NCT06909916

Start date

Jun 20, 2024

Status verified date

Aug, 2024

Completion date

May, 2025

Anticipated

Primary completion date

May, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Underwent revision surgery for repair of a distal femur fracture surrounding a primary TKA femoral component using a fracture fixation plate >1 year
  • 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:

  • Does not understand English
  • 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

20 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 undergone revision surgery for at least 1> year prior for their periprosthetic distal knee fracture.

Interventions

Periprosthetic Fracture Knee Repaired CT Scans

The investigators will be assessing the use of weight-bearing CT and conventional CT, specifically its imaging, with RSA-like software, for analyzing fracture healing for a periprosthetic distal knee fracture.

Primary outcome measure

  • Maximum Total Point Motion of Fracture Segments from Conventional CT scans [ Time Frame: 1 visit is only required for which the outcome measure will then be assessed. Through study completion, approximately of 1 year. ]
  • Maximum Total Point Motion of Fracture Segments from Conventional CT scans [ Time Frame: 1 visit is only required for which the outcome measure will then be assessed. Through study completion, approximately of 1 year. ]
  • Western Ontario and McMaster Universities Arthritis Index (WOMAC) Questionnaire [ Time Frame: 1 visit is only required for which the outcome measure will then be assessed. Through study completion, approximately of 1 year. ]
  • The Knee Society Score (KSS) Questionnaire [ Time Frame: 1 visit is only required for which the outcome measure will then be assessed. Through study completion, approximately of 1 year. ]
  • UCLA Activity Score Guideline Questionnaire [ Time Frame: 1 visit is only required for which the outcome measure will then be assessed. Through study completion, approximately of 1 year. ]

Central Contacts and Locations

Central contacts

Locations

University Hospital - London Health Sciences Centre

Recruiting

London, Ontario, Canada, N6A 5A5

Contacts

Farzan Mohammadreza Mohammadreza, MSc

519-729-8079farzan.mohammadreza@lhsc.on.ca

More Information

Sponsor

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

Last update posted

Apr 4, 2025

Last verified

Aug, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's on 2025-04-04.