ANZCTR12622000621718

Prospective registry for geniculate arterial embolisation as treatment for osteoarthritis and neovascularity.

PRAETORIAN: Prospective Registry for geniculate Arterial Embolisation as Treatment for OsteoaRthrItis And Neovascularity
I-MED Radiology Network·Not Applicable·Australian New Zealand Clinical Trials Registry·diagnostic testRecruiting
Study focus
Disease/Condition
Knee osteoarthritis
Study type
Observational
Intervention type
diagnostic test
Sponsor & location
Primary sponsor
I-MED Radiology Network
Funder
Bio-Excel ;; I-MED Radiology Network
Location
Australia
Timeline & enrollment
Phase
Not Applicable
Start date
May 08, 2023
End date
Feb 14, 2024
Primary outcome

Safety of the genicular artery embolisation (GAE) procedure measured by occurrence of adverse events as reported by the patient and investigators. Whilst severe or long-term complications are very rare, the most consistently reported side effect of GAE is non-target embolisation to the overlying skin resulting in temporary skin discoloration over the embolised territory. Other reported adverse events include moderate subcutaneous hemorrhage at the puncture site, small self-limiting groin hematoma, transient mild knee pain, self-resolving focal skin ulceration, and asymptomatic small bone infarct. ;; Overall efficacy of the genicular artery embolisation (GAE) procedure. This is a composite outcome. It is determined based on the results obtained from the changes in overall and current health status; patient-reported outcomes (PROMs); average knee joint pain; patient satisfaction and problems following GAE procedure; and patient expectations for pain, mobility, and health. These data will be collected from the study questionnaire.

Summary

Genicular artery embolisation (GAE) or embolisation of the knee is a minimally-invasive procedure used to reduce pain caused by KOA. GAE is a legitimate course of treatment for patients referred by their orthopaedic surgeons who meet the inclusion criteria. A small number of human studies investigating GAE in patients with knee osteoarthritis (KOA) have been conducted in Australia and internationally. We seek to establish a prospective registry on GAE to consolidate local experiences and collect evidence to affirm the safety and efficacy of GAE procedure in patients experiencing moderate-to-severe persistent chronic pain following total knee arthroplasty (TKA) and also those with moderate-to-severe knee OA who are not yet suitable for surgical intervention.

ICD-10 classifications
Chronic instability of kneeGonarthrosis [arthrosis of knee]Other hypertrophic osteoarthropathyDislocation, sprain and strain of joints and ligaments of kneePatellofemoral disorders
Data source
Registry
Australian New Zealand Clinical Trials Registry
Trial ID
ANZCTR12622000621718
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for ANZCTR12622000621718 through Pure Global AI's free database. This Not Applicable trial is sponsored by I-MED Radiology Network and is currently Recruiting. The study focuses on Knee osteoarthritis.

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