Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000621718
Ethics application status
Approved
Date submitted
11/04/2022
Date registered
27/04/2022
Date last updated
10/05/2023
Date data sharing statement initially provided
27/04/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Prospective registry for geniculate arterial embolisation as treatment for osteoarthritis and neovascularity.
Scientific title
PRAETORIAN: Prospective Registry for geniculate Arterial Embolisation as Treatment for OsteoaRthrItis And Neovascularity
Secondary ID [1] 306901 0
None
Universal Trial Number (UTN)
Trial acronym
PRAETORIAN
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Knee osteoarthritis 326009 0
Condition category
Condition code
Musculoskeletal 323314 323314 0 0
Osteoarthritis

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
12
Target follow-up type
Months
Description of intervention(s) / exposure
Genicular artery embolisation (GAE) or embolisation of the knee is a minimally-invasive procedure used to reduce pain caused by knee osteoarthritis (KOA).

We aim to establish a prospective registry to collect evidence on the safety and effectiveness of GAE in two distinct patient groups: a) patients experiencing moderate-to-severe persistent chronic pain due to neovascularization or haemarthrosis following total knee arthroplasty (TKA), and b) patients with moderate-to-severe KOA refractory to conservative or medical therapies who are not currently suitable total knee arthroplasty (TKA) candidates.

Patients referred by orthopaedic consultants (following the start date of the registry) to undergo GAE will be approached to be included in the registry. During the screening, the investigators will describe the nature of the patient registry and assess potential participants’ eligibility according to the registry’s inclusion/exclusion criteria. Eligible participants will be provided with a Patient Information and Consent Form (PICF). Participation in the prospective registry will be voluntary and potential participants will be given enough time to decide whether or not to take part in the registry. Referred patients will undergo the GAE procedure (per the investigational site’s standard of care) irrespective of their decision. Examinations, evaluations, treatment and hospital discharge procedures will be conducted per the investigational site’s standard of care.

Registry subjects are to be followed according to the investigational sites’ standard of care practices. There are no additional treatments or scans to be performed for the purpose of this registry. The only difference between the routine clinical practice and this registry is that participants will be asked to complete an online questionnaire at baseline and 6 and 12 months (±2 weeks) post-GAE for the registry. The anticipated time needed to complete the online questionnaire at each time point is 25 minutes.


The subject’s following information will be collected (directly from their health records and/or via a Data Collection form) for the registry:
- Demographic information (e.g. date of birth, sex, BMI, etc.)
- Medical history and list of medication
- FBC and U&E blood test results
- Knee radiographs and magnetic resonance imaging (MRI) results and interpretations. Imaging will be usually performed prior to GAE and may be repeated at the follow-up consultation at 3 months (±2 weeks) as per the investigational site’s standard of care
- Procedural information (e.g. type of embolic used, length of the procedure, injected contrast volume, skin dose, amount of embolic used, etc.)
- Adverse events (AEs) will be documented immediately after the GAE procedure and at the follow-up consultation at 3 months (±2 weeks) as per the investigational site’s standard of care. Each AE will be classified for its severity, or the intensity of an event, experienced by the subject


The online questionnaire will consist of the validated and standardised questionnaires used by the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) for patients undergoing knee replacement procedures. These include:
1. EQ-5D-5L questionnaire. The EQ-5D-5L is a standardised instrument for measuring overall health status. The descriptive system is comprised of 5 dimensions: mobility, personal care, usual activities, pain/discomfort and anxiety/depression.
2. EQ VAS. The EQ VAS is a validated self-rated health instrument. Patients are asked to indicate their current health status on a scale from 0 (the worst health patient can imagine) to 100 (the best health patient can imagine).
3. Oxford Knee Score. The Oxford Knee Score (OKS) is a standardised and validated patient-reported outcomes (PROMs) instrument developed to assess function and pain in patients undergoing knee surgery. The OKS provides a single summed score; the lower the scoring, the higher the severity of the patient’s problems.
4. KOOS-12. The KOOS-12 instrument is a 12-item measure derived from the original Knee Injury and Osteoarthritis Outcome Score (KOOS). KOOS-12 contains 4 KOOS Pain items, 4 KOOS Function (Activities of Daily Living and Sport/Recreation) items, and 4 KOOS Quality of Life (QOL) items. KOOS-12 reduces respondent burden by 70% from the original KOOS while providing scale scores for knee-specific pain, function and QoL, along with a summary measure of overall knee impact. To interpret KOOS scoring, the outcome measure is a scale from worst to best from 0 to 100, with 100 indicating no symptoms and 0 indicating extreme symptoms.
5. Average pain scale (last 7 days). Patients will use a scale to indicate the average knee joint pain they had experienced over the last 7 days (from 0: no pain at all to 10: the worst pain imaginable).
6. Expectation questions. Patients will be asked their expectations for pain, mobility, and health in 6 and 12 months’ time at the pre-operative collection point. At the post-GAE collection point, patients will rate their perceptions based on that day.
7. Satisfaction and joint change questions. At 6 and 12 months post-GAE timepoints, patients will be asked to describe how satisfied they are with the results of their procedures and their perceived change in the problems associated with their knee.
8. Side effects/Complications question. At 6 and 12 months post-GAE timepoints, patients will be asked to describe whether they experienced any side effects/complications following GAE.

The use of these questionnaires will allow us to directly compare GAE results with those collected from patients undergoing total knee replacement procedures from the National Joint Registery. The direct comparison is expected to provide crucial information for orthopaedic surgeons and affect future KOA pain management plans.
Intervention code [1] 323351 0
Diagnosis / Prognosis
Comparator / control treatment
The outcome of the questionnaires used in this registry will be compared to those collected from patients undergoing total knee replacement procedures by the Australian Orthopaedic Association National Joint Replacement Registry.
Control group
Active

Outcomes
Primary outcome [1] 331051 0
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.
Timepoint [1] 331051 0
Assessed immediately after the GAE procedure and at 6 and 12 months (±2 weeks) post GAE procedure.
Primary outcome [2] 331052 0
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.
Timepoint [2] 331052 0
Assessed at baseline (pre-GAE), and at 6 and 12 months (±2 weeks) post GAE procedure.
Secondary outcome [1] 408598 0
Change in overall health status measured by EQ-5D-5L questionnaire.
Timepoint [1] 408598 0
Assessed at baseline (pre-GAE), and at 6 and 12 months (±2 weeks) post GAE procedure.
Secondary outcome [2] 408599 0
Change in current health status measured EQ VAS scale.
Timepoint [2] 408599 0
Assessed at baseline (pre-GAE), and at 6 and 12 months (±2 weeks) post GAE procedure.
Secondary outcome [3] 408600 0
Change in patient-reported outcomes (PROMs) measured by Oxford Knee Score (assesses function and pain) questionnaire.
Timepoint [3] 408600 0
Assessed at baseline (pre-GAE), and at 6 and 12 months (±2 weeks) post GAE procedure.
Secondary outcome [4] 408601 0
Change in patient-reported outcomes (PROMs) measured by KOOS-12 (assesses pain, function, and quality of life) questionnaire (the questionnaire was amended to suit GAE procedure).
Timepoint [4] 408601 0
Assessed at baseline (pre-GAE), and at 6 and 12 months (±2 weeks) post GAE procedure.
Secondary outcome [5] 408602 0
Change in average knee joint pain, measured by Visual Analogue Scale (VAS).
Timepoint [5] 408602 0
Assessed at baseline (pre-GAE), and at 6 and 12 months (±2 weeks) post GAE procedure.
Secondary outcome [6] 408603 0
Patient expectation for pain, measured by an online question that was previously used by the Australian Orthopaedic Association National Joint Replacement Registry (the question was amended to suit the GAE procedure).
Timepoint [6] 408603 0
Assessed at baseline (pre-GAE), and at 6 and 12 months (±2 weeks) post GAE procedure.
Secondary outcome [7] 408604 0
Patient satisfaction following the GAE procedure, measured by an online question that was previously used by the Australian Orthopaedic Association National Joint Replacement Registry (the question was amended to suit the GAE procedure).
Timepoint [7] 408604 0
Assessed at 6 and 12 months (±2 weeks) post GAE procedure.
Secondary outcome [8] 408605 0
Current status of problems associated with knee joint following the GAE procedure, measured by an online question that was previously used by the Australian Orthopaedic Association National Joint Replacement Registry (the question was amended to suit the GAE procedure).
Timepoint [8] 408605 0
Assessed at 6 and 12 months (±2 weeks) post GAE procedure.
Secondary outcome [9] 408932 0
Patient expectation for mobility, measured by an online question that was previously used by the Australian Orthopaedic Association National Joint Replacement Registry (the question was amended to suit the GAE procedure).
Timepoint [9] 408932 0
Assessed at baseline (pre-GAE), and at 6 and 12 months (±2 weeks) post GAE procedure.
Secondary outcome [10] 408933 0
Patient expectation for their health, measured by an online question that was previously used by the Australian Orthopaedic Association National Joint Replacement Registry (the question was amended to suit the GAE procedure).
Timepoint [10] 408933 0
Assessed at baseline (pre-GAE), and at 6 and 12 months (±2 weeks) post GAE procedure.

Eligibility
Key inclusion criteria
Inclusion criteria for group A (patients with moderate-to-severe chronic pain following TKA):
- Age 40 yrs or older who are willing and able to provide informed consent
- Experiencing ongoing moderate to severe pain for at least 6 months after total knee arthroplasty
- and having failed conservative medical treatment for at least 6 months (e.g. physiotherapy/anti-inflammatory/analgesia/masso-kinesiotherapy, etc.)



Inclusion criteria for group B (patients with moderate-to-severe KOA):
- Age 40 yrs or older who are willing and able to provide informed consent
- Presence of moderate to severe knee OA as stipulated by referring orthopedic surgeon
- Presence of knee pain for at least 6 months, resistant to conservative treatments (e.g. physiotherapy, analgesia, exercise, weight loss, intra-articular injections, etc.)
- Non-surgical candidates: ineligible/refused total knee arthroplasty (TKA)
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria for group A (patients with moderate-to-severe chronic pain following TKA):
- Rheumatoid, infectious arthritis, osteonecrosis, or advanced atherosclerosis
- Malignancy
- Renal impairment (eGFR <45)
- A bleeding diathesis
- Irreversible coagulopathy
- Re-operation
- Allergic to contrast media



Exclusion criteria for group B (patients with moderate-to-severe KOA):
- Rheumatoid, infectious arthritis, osteonecrosis, or advanced atherosclerosis
- Malignancy
- Renal impairment (eGFR <45)
- A bleeding diathesis
- Irreversible coagulopathy
- Allergic to contrast media

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
This will be a prospective registry designed to collect and analyse sufficient patient data to confirm the efficacy and safety of a pre-existing procedure that is attracting increased clinical use globally.
The safety (i.e. number and percentage of adverse outcomes) and GAE efficacy will be determined by evaluating data obtained from pre-procedural, intra-procedural and post-procedural timepoints. Questionnaire data collected at baseline and 6 and 12 months post-GAE procedure will be analysed using appropriate statistical tests to determine the efficacy of GAE for pain management. In addition, obtained results will be compared to those collected by the Australian Orthopaedic Association National Joint Replacement Registry. This will allow us to perform a direct comparison analysis, which will provide crucial information about the safety and effectiveness of GAE compared to knee replacement procedures. Descriptive statistics will be used as appropriate, for example, when presenting data on patient characteristics such as mean, median and range of patient age and BMI.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
8/05/2023
Actual
Date of last participant enrolment
Anticipated
14/02/2024
Actual
Date of last data collection
Anticipated
14/02/2025
Actual
Sample size
Target
150
Accrual to date
0
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 22186 0
The Wesley Hospital - Auchenflower
Recruitment hospital [2] 22187 0
St Andrew's War Memorial Hospital - Brisbane
Recruitment hospital [3] 22188 0
The Prince Charles Hospital - Chermside
Recruitment hospital [4] 22189 0
Sunshine Coast University Private Hospital - Birtinya
Recruitment postcode(s) [1] 37341 0
4000 - Brisbane
Recruitment postcode(s) [2] 37342 0
4032 - Chermside
Recruitment postcode(s) [3] 37340 0
4066 - Auchenflower
Recruitment postcode(s) [4] 37343 0
4575 - Birtinya

Funding & Sponsors
Funding source category [1] 311214 0
Commercial sector/Industry
Name [1] 311214 0
Bio-Excel
Country [1] 311214 0
Australia
Funding source category [2] 311216 0
Commercial sector/Industry
Name [2] 311216 0
I-MED Radiology Network
Country [2] 311216 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
I-MED Radiology Network
Address
Wesley Specialist Centre
Level 1
87 Lang Pde
Auchenflower
QLD
4066
Country
Australia
Secondary sponsor category [1] 312583 0
None
Name [1] 312583 0
Address [1] 312583 0
Country [1] 312583 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310742 0
UnitingCare Human Research Ethics Committee
Ethics committee address [1] 310742 0
UnitingCare Health Human Research Ethics Committee
Ground Floor Moorlands House
The Wesley Hospital
451 Coronation Drive, Auchenflower QLD 4066
PO Box 499 Toowong QLD 4066
Ethics committee country [1] 310742 0
Australia
Date submitted for ethics approval [1] 310742 0
07/01/2022
Approval date [1] 310742 0
20/05/2022
Ethics approval number [1] 310742 0
202201

Summary
Brief 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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 118710 0
Dr Nicholas Brown
Address 118710 0
I-MED Radiology
Level 2 Sandford Jackson Building
The Wesley Hospital
30 Chasely St
Auchenflower
QLD
4066
Country 118710 0
Australia
Phone 118710 0
+61403 324 362
Fax 118710 0
Email 118710 0
nicholas.brown@i-med.com.au
Contact person for public queries
Name 118711 0
Dr Sepinoud Firouzmand
Address 118711 0
I-MED Radiology
Wesley Specialist Centre
Level 1
87 Lang Pde
Auchenflower
QLD
4066
Country 118711 0
Australia
Phone 118711 0
+61 7 3371 9588
Fax 118711 0
Email 118711 0
research@i-med.com.au
Contact person for scientific queries
Name 118712 0
Dr Sepinoud Firouzmand
Address 118712 0
I-MED Radiology
Wesley Specialist Centre
Level 1
87 Lang Pde
Auchenflower
QLD
4066
Country 118712 0
Australia
Phone 118712 0
+61 7 3371 9588
Fax 118712 0
Email 118712 0
research@i-med.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
It is not anticipated that patient information will be shared outside the registry investigator group.
Publishing/sharing of de-identified data via conference presentations or journal articles is planned to share the cohort data publicly.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.