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Weight-Bearing CT Periprosthetic Distal Knee Fractures

StatusRecruiting
PhaseNot applicable
Started2025-09-24
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 23 months later Aug 2025 → Aug 2027
See other at-risk trials from London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Amendment history

2026-09-18
critical
Trial status changed: Unknown → Recruiting
Primary completion pushed: 2025-08 → 2027-08
Completion pushed: 2025-08 → 2027-08
2026-08-02
minor
Trial status changed: Not Yet Recruiting → Unknown
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.
Trial Details
NCT Number NCT06525610
Lead Sponsor London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Conditions Periprosthetic Fracture Around Prosthetic Joint Implant Knee
Enrollment 21 participants
Start Date 2025-09-24
Primary Completion 2027-08 (estimated)
Study Completion 2027-08 (estimated)
Updated on ClinicalTrials.gov 2026-09-29