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Trial registered on ANZCTR


Registration number
ACTRN12616000770460
Ethics application status
Approved
Date submitted
11/06/2016
Date registered
14/06/2016
Date last updated
24/04/2019
Date data sharing statement initially provided
24/04/2019
Date results information initially provided
24/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating transcatheter arterial embolisation for improvement of pain in osteoarthritis (OA) of the knee - a pilot study
Scientific title
Evaluating transcatheter arterial embolisation for improvement of pain in osteoarthritis (OA) of the knee - a pilot study
Secondary ID [1] 289414 0
none
Universal Trial Number (UTN)
Trial acronym
EIEIO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Knee osteoarthritis 299087 0
Condition category
Condition code
Musculoskeletal 299118 299118 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will have abnormal blood vessels about the study knee embolised. Participants will receive a local anaesthetic (1% lignocaine) injected into their groin. Femoral artery access will be obtained with a 3French sheath and a micro-catheter introduced. Digital subtraction angiogram using contrast (iodine-containing contrast medium) will be obtained of the knee identifying abnormal neovasculature arising from the genicular arterial branches. The abnormal vessels will be embolised with <500um embolic material. The guide wire will be removed. A dressing will be applied to the puncture site.

All procedures will be conducted by a fully qualified interventional radiologist who is trained to perform vascular embolisation.

The procedure is expected to take 30-60minutes depending on the number of vessels embolised.
Intervention code [1] 295001 0
Treatment: Surgery
Intervention code [2] 295002 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 298588 0
Change in knee pain as assessed by the Knee injury and Osteoarthritis Outcome Score (KOOS)
Timepoint [1] 298588 0
1 month post intervention
Secondary outcome [1] 324657 0
Change in knee pain as assessed by the Knee injury and Osteoarthritis Outcome Score (KOOS)
Timepoint [1] 324657 0
6,12,24 months post intervention
Secondary outcome [2] 324658 0
Change in self-reported physical function as measured by the KOOS Function Daily Living scale and KOOS Function, Sports and Recreational Activities scale
Timepoint [2] 324658 0
1, 6, 12 and 24 months post intervention
Secondary outcome [3] 324659 0
Change in self-reported joint stiffness as measured by the KOOS Stiffness scale
Timepoint [3] 324659 0
1,6,12 and 24 months post intervention
Secondary outcome [4] 324660 0
Change in self-reported quality of life as measured by the EQ-5D-5L and KOOS Quality of life scale
Timepoint [4] 324660 0
1,6,12 and 24 months post intervention
Secondary outcome [5] 324661 0
Self-reported global overall change (7 point ordinal scale)
Timepoint [5] 324661 0
1,6,12, and 24 months post intervention
Secondary outcome [6] 324662 0
Self-reported global overall change in pain (7 point ordinal scale)
Timepoint [6] 324662 0
1,6,12, and 24 months post intervention
Secondary outcome [7] 324663 0
Self-reported global overall change in physical function (7 point ordinal scale)
Timepoint [7] 324663 0
1,6,12, and 24 months post intervention
Secondary outcome [8] 324665 0
Change in six minute walk test performance
Timepoint [8] 324665 0
1,6,12 and 24 months post intervention
Secondary outcome [9] 324666 0
Change in 30 second chair stand test performance
Timepoint [9] 324666 0
1,6,12,and 24 months post intervention
Secondary outcome [10] 324667 0
Change in pharmacotherapy usage (patient report of the frequency and dosage of medication) for knee pain secondary to OA
Timepoint [10] 324667 0
1,6,12 and 24 months post intervention

Eligibility
Key inclusion criteria
1. People aged 18 to 75 years
2. Grade 1 or 2 knee OA (obtained via baseline imaging (X-Ray) as per Kellgren-Lawrence Grading Scale)
3. Moderate to severe knee pain
4. Pain resistant to conservative treatment
a. Conservative treatment includes medication (e.g. paracetamol, anti-inflammatories), or intra-articular injections, or physiotherapy or exercise, or weight loss.
5. Participants must be willing, able and mentally competent to provide informed consent (able to read and understand the Patient Information and Consent Form).
Minimum age
18 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Local infection
2. Active malignancy
3. Rheumatoid Arthritis or Seronegative Arthropathies
4. Prior Ipsilateral Knee Surgery
5. Kellgren-Lawrence Grade 3 and above
6. Current pregnancy
a. If participant is unsure of their current pregnancy status clarification from their GP including arranging a pregnancy test and following up the result can be obtained
7. Known history of allergy to contrast media
8. Reduced kidney function or failure (chronic or acute)
a. Acute kidney injury (Defined by KDIGO: Increase in a participant’s serum creatinine level by >0.3mg/dL (>26.5 micromol/L) within 48 hours OR Increase in a participants serum creatinine by >1.5x their baseline OR Oliguria (urinary output <0.5mL/kg/hr) for 6 hours
9. Weight greater than 200kg
10. Barwon Medical Imaging Protocols:
a.Platelets < 100 x 109/L
b. INR > 1.5
c. Estimated GFR < 30ml/min.1.73m2
11. Approved for knee joint replacement surgery
12. Moderate to severe pain in other lower limb joints

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
There is no concealment. All participants will receive the intervention and know that they are receiving the intervention.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not appliable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
Adverse events
Close monitoring for adverse events will occur in the first month post intervention. Participants will be observed for 4 hours post intervention and discharged home if no adverse events occur. Participants will then be assessed for adverse events the next day (phone) and at weekly intervals (alternating phone and in person) until four weeks.

Pain, function, and quality of life
The primary analysis will be performed on the transformed KOOS pain scale, using percentage reduction from baseline and a two-sample t-test if no dropout occurs and all 12 month data is available on each participant. Normality of the outcomes will be assessed, and if the assumptions are not met, the primary analysis will be conducted using the Wilcoxon rank sum test.

In the case of dropouts or missing data at 12 months, the primary analysis will be conducted under a linear regression model, with random effects accounting for intra-individual correlations.

Secondary outcomes:
Outcome data that is available at multiple time points will also be analysed using linear regression model, with random effects accounting for intra-individual correlations. Differences between intervention and placebo arms will be analysed and presented for each timepoint using a time-by-intervention product term.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 5953 0
Barwon Health - Geelong Hospital campus - Geelong
Recruitment postcode(s) [1] 13379 0
3220 - Geelong

Funding & Sponsors
Funding source category [1] 293787 0
Other
Name [1] 293787 0
Barwon Medical Imaging
Address [1] 293787 0
c/o University Hospital Geelong,
PO Box 281
Geelong, Victoria, Australia, 3220
Country [1] 293787 0
Australia
Primary sponsor type
Other
Name
Barwon Medical Imaging
Address
c/o University Hospital Geelong,
PO Box 281
Geelong, Victoria, Australia, 3220
Country
Australia
Secondary sponsor category [1] 292621 0
None
Name [1] 292621 0
Address [1] 292621 0
Country [1] 292621 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295222 0
Barwon Health Human Research Ethics Committee
Ethics committee address [1] 295222 0
Research Ethics Governance and Integrity Unit
Barwon Health
PO Box 281
Geelong, Victoria, Australia, 3220
Ethics committee country [1] 295222 0
Australia
Date submitted for ethics approval [1] 295222 0
25/08/2015
Approval date [1] 295222 0
31/05/2016
Ethics approval number [1] 295222 0

Summary
Brief summary
Knee osteoarthritis (OA) is a leading cause of pain and disability around the world. OA involves the breakdown of joint cartilage, but it also appears to include the proliferation of blood vessels and nerves about the joint. It is suggested that these blood vessels and nerves contribute to the experience of pain. One pilot study found that embolising abnormal vessels about the knee substantially improved individual's pain.

Prior to a full randomised trial, 10 participants will be recruited to this non-randomised pilot study. The purpose of the pilot study is to test the protocol for feasibility and assess for effects on pain and function and any unexpected effects due to the intervention in the first month post procedure.

All pilot study participants will unblinded and will receive the intervention. Participants will be reassessed the day following the intervention and then once a week for the first month. At each assessment, participants will complete an abbreviated assessment (KOOS, Global Assessment of Change, Six Minute Walk Test and 30-second Chair Stand Test). Participants will then complete full assessments (using all assessment tools) at 1, 6, 12, and 24 months following the procedure.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 66590 0
Dr Steve Landers
Address 66590 0
c/o Barwon Medical Imaging
Barwon Health
PO Box 281
Geelong, Victoria, Australia,
3220
Country 66590 0
Australia
Phone 66590 0
+61 3 42150000
Fax 66590 0
Email 66590 0
stevel@barwonhealth.org.au
Contact person for public queries
Name 66591 0
Ms Rachael Hely
Address 66591 0
c/o Barwon Medical Imaging
Barwon Health
PO Box 281
Geelong, Victoria, Australia
3220
Country 66591 0
Australia
Phone 66591 0
+61 3 42150000
Fax 66591 0
Email 66591 0
Rachaehe@barwonhealth.org.au
Contact person for scientific queries
Name 66592 0
Dr Stephen Gill
Address 66592 0
c/o Barwon Medical Imaging
Barwon Health
PO Box 281
Geelong, Victoria, Australia
3220
Country 66592 0
Australia
Phone 66592 0
+61 3 42150000
Fax 66592 0
Email 66592 0
steveg@barwonhealth.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The investigators are currently discussing their intentions for data sharing.
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary