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Trial registered on ANZCTR

Registration number

ACTRN12622001157763

Ethics application status

Approved

Date submitted

1/07/2021

Date registered

24/08/2022

Date last updated

24/08/2022

Date data sharing statement initially provided

24/08/2022

Type of registration

Prospectively registered

Titles & IDs

Public title

Genicular artery embolisation and the effect on Knee Osteoarthritis - a randomised controlled trial.

Scientific title

Safety and Efficacy of Genicular artery embolisation and the effect on knee osteoarthritis - a randomised controlled trial.

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

Trial acronym

KOGAE trial.

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Knee osteoarthritis

Condition category

Condition code

Musculoskeletal

Osteoarthritis

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The research team will be studying the impact that embolisation of neo-vascularisation of the geniculate arteries has on patient’s pain and functional outcomes associated with their knee osteoarthritis.

Brief name: geniculate artery embolization, there will be two arms to this study; an intervention arm and a placebo/control arm.

The procedures will be carried out face to face by a qualified Interventional Radiologist with a minimum of 3 years’ experience of performing endovascular procedures. The procedures will be carried out at the interventional radiology department within Liverpool Hospital, NSW, Australia. The team aims to carry out one procedure for each participant with the timing of procedures ranging from 2-3hours.

Intervention description:
The contralateral/ipsilateral femoral artery or ipsilateral dorsalis pedis artery will be assessed with ultrasound. The region will be prepped utilising sterile technique.
The artery will be punctured; an endovascular sheath used to replace the needle using seldinger technique. Guide wires, angiographic catheters/microcatheters will be advanced to the affected knee and the abnormal/neovascularised vessels will be imaged with diagnostic angiography.
The abnormal arteries will then be embolised utilising micron embosphere beads.

Vessel anatomy and the abnormal/neovascularised vessels will differ from one patient to another. Thus, each participant will have personalised or adapted treatment. These personalised differences will range from
- Puncture/ arterial access site.
- Type of catheters/microcatheters used.
- Number of vessels embolised.
- Determine the number of vessels needed to be embolised due to the patient’s symptoms at the time of the original consultation.

These treatment differences will occur at the time of the intervention.

The procedure is a one time procedure, there is no need for strategies to monitor adherence/fidelity.

Intervention code [1]

Treatment: Other

Comparator / control treatment

The intervention group will be compared with the placebo/control group.
Within this group, each participant will have the contralateral/ipsilateral femoral artery or ipsilateral dorsalis pedis artery will be assessed with ultrasound. The region will be prepped utilising sterile technique.
The artery will be punctured; an endovascular sheath used to replace the needle using seldinger technique. Guide wires, angiographic catheters/microcatheters will be advanced to the affected knee and the abnormal/neo-vascularised vessels will be imaged with diagnostic angiography.

No embolisation will be performed.

The procedures will not be directly matched (timing wise) as some patients may have more complex anatomy requiring a longer time for the procedure to be completed compared to others. The research team does have a minimum procedure duration time of 30 minutes to ensure that the comparator procedure will be of an appropriate time to resemble the actual procedure to the intervention procedure.

Control group

Placebo

Outcomes

Primary outcome [1]

Safety of transcatheter arterial embolisation of genicular arteries in the treatment of pain from knee osteoarthritis.

Safety will be monitored at a variety of check points.
all adverse events will documented and alerted to the principle sponsor and the local HREC office.

Timepoint [1]

Patients will be monitored at regular intervals post procedure for 12 months. These intervals include day 1 post procedure, week one post procedure, 1,3,6 and 12 months post procedure.

Primary outcome [2]

Efficacy of transcatheter arterial embolisation of genicular arteries in the treatment of pain from knee osteoarthritis.

Treatment efficacy is assessed via a composite of the VAS and Knee injury and osteoarthritis outcome score.

Timepoint [2]

The time points for assessment will be at
baseline, day 1, 1 week, 3 months, 6 months and 12 months (primary end point) post procedure.

Primary outcome [3]

Assessment of pain in patients who undergo genicular artery embolisation in comparison with the control group who do not undergo the procedure.
Pain will be assessed by a composite of the Visual analogue scale, Knee injury osteoarthritis outcome score and the usage of their analgesia (reduction or increase).
Analgesia usage will be determined by review of the participants diaries.

Timepoint [3]

Pain will be assessed at the previously mentioned time points i.e. at baseline, day 1, 1 week, 3 months, 6 months and 12 months (primary end point) post procedure

Secondary outcome [1]

Assessment of quality of life in patients who undergo genicular artery embolisation in comparison with the control group who do not undergo the procedure.

Quality of life will be assessed via a subset of the questions in the knee injury and osteoarthritis outcome score.

Timepoint [1]

The time points for assessment will be at
baseline, day 1, 1 week, 3 months, 6 months and 12 months post procedure.

Secondary outcome [2]

Pedal vessel patency

Timepoint [2]

ultrasound of the pedal arteries will be done at baseline and then one week post procedure.

Eligibility

Key inclusion criteria

>40 years of age.
Grade 2 and 3 knee Osteoarthritis on plain radiographs (Kellgren-lawrence scale).
Knee pain for 6 months or more, moderate to severe knee pain (VAS >50mm).
Pain refractory to conservative management for at least 3 months.
Patients capable of consenting for the trial.

Minimum age

41 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Current local infection.
Life expectancy is less than 6 months.
Active malignancy.
Grade 1 or 4 knee OA on x-rays as per Kellgren-Lawrence Grading scale.
Known advanced atherosclerosis in lower limb.
Rheumatoid or infectious arthritis.
Prior ipsilateral knee surgery excluding arthroscopic surgery more than three months ago.
Uncorrectable coagulopathy greater with INR greater than 1.5 (APTT will not be taken).
Renal dysfunction as defined by eGFR <45 within the last 60 days.
Contraindications for MR imaging.
Known history of allergy to contrast media.
Women who are lactating, pregnant or trying to become pregnant.
Patients with a history of psychological illness, especially severe depression.

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)

The allocation was concealed by utilising a computer based randomisation.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Dynamic random allocation method (minimisation).

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s

The people assessing the outcomes

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

54 patients (27 in each arm) in total are needed for statistical significance. This is based on previous research which states that the mean Knee Injury and Osteoarthritis Severity Score (KOOS) ranges from 48-57, assuming an average of 50 with a standard deviation of 13 and assuming a 20% reduction in the KOOS score will be significant. Thus a total of 54 patients (27 in each group is needed).

After compiling all study questionnaires, the overall assessment between the two groups will be carried out using two sample T tests to assess the difference between intervention and placebo group. In addition, the use of means, medians and averages will also allow understanding of the cohort demographics (age, KOOS score etc). The above statistics was discussed with a statistician prior to ethics lodgement.

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

1/09/2022

Actual

Date of last participant enrolment

Anticipated

30/06/2023

Actual

Date of last data collection

Anticipated

31/07/2024

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

Liverpool Hospital - Liverpool

Recruitment postcode(s) [1]

2170 - Liverpool

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Merit Medical

Address [1]

53 Canterbury Rd, Braeside VIC 3195

Country [1]

Australia

Funding source category [2]

Commercial sector/Industry

Name [2]

Terumo Medical Corporation

Address [2]

5 Talavera Rd, Macquarie Park NSW 2113

Country [2]

Australia

Primary sponsor type

Hospital

Name

South Western Sydney Local health District

Address

South Western Sydney Local Health District Executive Office
Liverpool Hospital Eastern Campus
Scrivener Street
LIVERPOOL NSW 2170

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

South Western Sydney Local Health District

Ethics committee address [1]

South Western Sydney Local Health District Executive Office
Liverpool Hospital Eastern Campus
Scrivener Street
LIVERPOOL NSW 2170

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

17/05/2022

Approval date [1]

27/05/2022

Ethics approval number [1]

Summary

Brief summary

Osteoarthritis (OA) is a chronic and progressive condition affecting 1 in 8 Australians. Recent advancement suggests that there is a vascular (formation of new vessels) and inflammatory component associated with OA. 

Osteoarthritis of the knee is the most common form of OA. The risk of functional limitations from knee osteoarthritis is greater than that from any other medical condition for those aged 65 and above.

Blockage (embolisation) of these newly developed blood vessels in knee OA represents a method to reduce a patient's symptoms but also delay the progression of their condition. Across Japan, USA and UK, many researchers have looked at the safety and efficacy in carrying out embolisation of geniculate arteries. These studies have shown a reduction in patient’s pain and nil adverse outcomes associated with the procedure itself. This procedure represents a potential intermediate management tool with reduction in the costs associated with total knee replacements as well as increasing economic productivity for patients and the community. 
 
This study hypothesises that patients who undergo blockage of the newly developed vessels will result in a reduction in analgesic consumption and an increase in quality of life for patients in comparison to the placebo. 

This study aims to compare geniculate artery embolisation with non-procedural intervention to ascertain further data and aid the growing literature in the global community for the use of this procedure as a method to manage patients with osteoarthritis.

Participants will be assessed prior with a thorough clinical/medication history, physical examination and a questionnaire (visual analogue scale and Knee injury and osteoarthritis severity score) related to the patient’s experience with regards to their knee issues. 

Once the participant has consented and enrolled in the study. The study will randomise participants into an intervention group (those that receive the blockage of vessels) and those that do not. Both participants will be followed up post procedure at the 1 day, 1 week, 1 month, 3-month, 6 month and 12-month mark for functional and subjective assessment of the knee.

Trial website

Trial related presentations / publications

Public notes



Okuno Y, Korchi AM, Shinjo T, et al. Transcatheter Arterial Embolization as a Treatment for Medial Knee Pain in Patients with Mild to Moderate Osteoarthritis. Cardiovasc Intervent Radiol 2015;38:336–43. doi:10.1007/s00270-014-0944-8

Okuno Y, Korchi AM, Shinjo T, et al. Midterm Clinical Outcomes and MR Imaging Changes after Transcatheter Arterial Embolization as a Treatment for Mild to Moderate Radiographic Knee Osteoarthritis Resistant to Conservative Treatment. J Vasc Interv Radiol 2017;28:995–1002. doi:10.1016/j.jvir.2017.02.033

Landers S, Hely A, Harrison B, et al. Protocol for a single-centre, parallel-arm, randomised controlled superiority trial evaluating the effects of transcatheter arterial embolisation of abnormal knee neovasculature on pain, function and quality of life in people with knee osteoarthritisBMJ Open 2017;7:e014266. doi: 10.1136/bmjopen-2016-014266

Contacts

Principal investigator

Name

Dr Yehia El Hgar

Address

Liverpool Hospital, Corner of Elizabeth and Goulburn Street, Liverpool, NSW 2127

Country

Australia

Phone

+61428355658

Fax

y.elhgar@gmail.com

Contact person for public queries

Name

Jasjit Walia

Address

Liverpool Hospital, Corner of Elizabeth and Goulburn Street, Liverpool, NSW, 2127

Country

Australia

Phone

+6187383462

Fax

jasjit.walia@health.nsw.gov.au

Contact person for scientific queries

Name

Jasjit Walia

Address

Liverpool Hospital, Corner of Elizabeth and Goulburn Street, Liverpool, NSW, 2127

Country

Australia

Phone

+61287383462

Fax

jasjit.walia@health.nsw.gov.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

Once summation of results and interpretation of results has occurred, then these results will be published. Only aggregate results will be shared. No individual data results will be released.

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

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