Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001218684
Ethics application status
Approved
Date submitted
10/10/2023
Date registered
27/11/2023
Date last updated
27/11/2023
Date data sharing statement initially provided
27/11/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Genicular artery embolisation vs Sham procedure for knee pain secondary to total knee replacement.
Scientific title
Genicular artery embolisation vs Sham procedure for knee pain secondary to total knee replacement.
Secondary ID [1] 310559 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Knee pain secondary to total knee replacements 331391 0
Condition category
Condition code
Surgery 328138 328138 0 0
Surgical techniques
Musculoskeletal 328596 328596 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Genicular artery embolisation (GAE) is a procedure involving injection of small particles into knee joint arteries. It involves digital subtraction angiography to confirm areas of enhancement ("tumour blush") followed by embolisation of arteries using particles called embospheres. This inhibits growth of new blood vessels (neovascularity) and decreases inflammation.

Trans-Arterial Embolisation of the Genicular Arteries (GAE) procedure:
1. Pre-procedural Consent: Highlighting complications of the procedure.
2. Trans-femoral arterial access.
3. Allergies: Medication or iodinated contrast.
4. Light sedation (intravenous) - Midazolam and Fentanyl as needed.
5. Angiography and intervention:
a. Selective catheter angiography of superficial femoral artery identifying geniculate vessels perfusing areas of synovial hyperaemia “blushing”.
b. Super selective micro-catheterisation and embolisation of the target vessels “blush areas” with a mixture of iodinated contrast media and 100-300µm Embosphere particles (Merit Medical, USA).
c. Technical success is defined as an absent “blush” of feeding arteries.
d. Final angiography is performed to assess for complications of non-target distal embolisation.
6. Puncture site closure: FemoSeal® vascular closure device.

- This procedure will be a one-off 30 minute procedure performed by an interventional radiologist

- This procedure will be carried out on patients at least 12 months following total knee replacement, and at least 6 months of insufficient response to conservative and medical therapy

- Patients will be followed up at 2 weeks, 6 weeks, 3 months, 6 months and 12 months

- As this is a one-off procedure there will be no need to monitor adherence to the intervention
Intervention code [1] 326963 0
Treatment: Other
Comparator / control treatment
Sham procedure (GAE mimic):

Sham procedure will mimic the GAE. In this procedure, a small groin incision is made over the femoral artery anatomical landmark site. No puncture of the femoral artery will take place. Gentle bimanual pressure is then palpated over the femoral artery access point whilst patient watches a screening recording of GAE angiography. The incision site is then closed with simple sutures.

- Light sedation will be used (intravenous) - Midazolam and Fentanyl as needed.


- This procedure will be a one-off 30 minute procedure performed by an interventional radiologist

- Patients will be followed up at 2 weeks, 6 weeks, 3 months, 6 months and 12 months

- As this is a one-off procedure there will be no need to monitor adherence to the intervention
Control group
Placebo

Outcomes
Primary outcome [1] 336028 0
Change in Knee Osteoarthritis and Outcome Score (KOOS) with GAE compared with Sham procedure in knees with total knee replacements
Timepoint [1] 336028 0
Baseline (T-1) - KOOS will be measured at this time
Immediately post-procedure (T0) - KOOS will be measured at this time
3 months (T3) - KOOS will be measured at this time
6 months (T4) - KOOS will be measured at this time
12 months (T5) - KOOS will be measured at this time
Secondary outcome [1] 426510 0
Change in knee pain as assessed using Visual Analogue Scale (VAS) following GAE compared with Sham procedure in knees with total knee replacements
Timepoint [1] 426510 0
Baseline (T-1) - VAS will be measured at this time
Immediately post-procedure (T0) - VAS will be measured at this time
3 months (T3) - VAS will be measured at this time
6 months (T4) - VAS will be measured at this time
12 months (T5) - VAS will be measured at this time

Eligibility
Key inclusion criteria
Patient willing and able to consent to participate in the study
Age 40-75 years
Knee pain for a duration of > 6 months
Insufficient response to conservative and medical treatment for > 6 months
Be able to lie flat for 90 minutes
Baseline VAS (visual analogue scale, 0–100) > 50
Minimum age
40 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Musculoskeletal comorbidity (e.g., rheumatoid arthritis, gout)
Contraindications for angiography
Infectious arthritis
Renal impairment (estimated glomerular filtration rate <30)
Uncorrectable coagulopathy
Requires oxygen on ambulation
Life expectancy <1 year
Communication difficulty due to language barriers
History of peripheral arterial disease with intermittent claudication and/or rest pain
Pregnancy or positive pregnancy test
Trauma to the knee within last 12 months
Correctable causes for painful total knee replacement (Infection, malalignment, loosening) identified by treating surgeon

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/12/2023
Actual
Date of last participant enrolment
Anticipated
1/04/2024
Actual
Date of last data collection
Anticipated
1/05/2025
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 25509 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 41324 0
6000 - Perth

Funding & Sponsors
Funding source category [1] 314763 0
Hospital
Name [1] 314763 0
Royal Perth Hospital (Imaging Research Fund)
Country [1] 314763 0
Australia
Primary sponsor type
Individual
Name
Dr Julian Soares
Address
Royal Perth Hospital, Victoria Square, Perth WA 6000
Country
Australia
Secondary sponsor category [1] 316747 0
Individual
Name [1] 316747 0
Dr William Blakeney
Address [1] 316747 0
Royal Perth Hospital, Victoria Square, Perth WA 6000
Country [1] 316747 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313771 0
Royal Perth Hospital Human Research Ethics Committee (EC00270)
Ethics committee address [1] 313771 0
Ethics committee country [1] 313771 0
Australia
Date submitted for ethics approval [1] 313771 0
26/10/2023
Approval date [1] 313771 0
10/11/2023
Ethics approval number [1] 313771 0

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

Contacts
Principal investigator
Name 129310 0
Dr Julian Soares
Address 129310 0
Royal Perth Hospital, Victoria Square, Perth WA 6000
Country 129310 0
Australia
Phone 129310 0
+61 08 6457 3333
Fax 129310 0
Email 129310 0
[email protected]
Contact person for public queries
Name 129311 0
Julian Soares
Address 129311 0
Royal Perth Hospital, Victoria Square, Perth WA 6000
Country 129311 0
Australia
Phone 129311 0
+61 08 6457 3333
Fax 129311 0
Email 129311 0
[email protected]
Contact person for scientific queries
Name 129312 0
Julian Soares
Address 129312 0
Royal Perth Hospital, Victoria Square, Perth WA 6000
Country 129312 0
Australia
Phone 129312 0
+61 08 6457 3333
Fax 129312 0
Email 129312 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.