ANZCTR - Registration

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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

5/04/2023

Date data sharing statement initially provided

24/04/2019

Date results provided

5/04/2023

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]

none

Universal Trial Number (UTN)

Trial acronym

EIEIO

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

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]

Treatment: Surgery

Intervention code [2]

Treatment: Other

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Change in knee pain as assessed by the Knee injury and Osteoarthritis Outcome Score (KOOS)

Timepoint [1]

1 month post intervention

Secondary outcome [1]

Change in knee pain as assessed by the Knee injury and Osteoarthritis Outcome Score (KOOS)

Timepoint [1]

6,12,24 months post intervention

Secondary outcome [2]

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]

1, 6, 12 and 24 months post intervention

Secondary outcome [3]

Change in self-reported joint stiffness as measured by the KOOS Stiffness scale

Timepoint [3]

1,6,12 and 24 months post intervention

Secondary outcome [4]

Change in self-reported quality of life as measured by the EQ-5D-5L and KOOS Quality of life scale

Timepoint [4]

1,6,12 and 24 months post intervention

Secondary outcome [5]

Self-reported global overall change (7 point ordinal scale)

Timepoint [5]

1,6,12, and 24 months post intervention

Secondary outcome [6]

Self-reported global overall change in pain (7 point ordinal scale)

Timepoint [6]

1,6,12, and 24 months post intervention

Secondary outcome [7]

Self-reported global overall change in physical function (7 point ordinal scale)

Timepoint [7]

1,6,12, and 24 months post intervention

Secondary outcome [8]

Change in six minute walk test performance

Timepoint [8]

1,6,12 and 24 months post intervention

Secondary outcome [9]

Change in 30 second chair stand test performance

Timepoint [9]

1,6,12,and 24 months post intervention

Secondary outcome [10]

Change in pharmacotherapy usage (patient report of the frequency and dosage of medication) for knee pain secondary to OA

Timepoint [10]

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

Sex

Both males and females

Can healthy volunteers participate?

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

Completed

Date of first participant enrolment

Anticipated

20/06/2016

Actual

1/08/2016

Date of last participant enrolment

Anticipated

30/09/2016

Actual

16/02/2017

Date of last data collection

Anticipated

30/04/2019

Actual

19/06/2019

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Barwon Health - Geelong Hospital campus - Geelong

Recruitment postcode(s) [1]

3220 - Geelong

Funding & Sponsors

Funding source category [1]

Other

Name [1]

Barwon Medical Imaging

Address [1]

c/o University Hospital Geelong,
PO Box 281
Geelong, Victoria, Australia, 3220

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Barwon Health Human Research Ethics Committee

Ethics committee address [1]

Research Ethics Governance and Integrity Unit
Barwon Health
PO Box 281
Geelong, Victoria, Australia, 3220

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

25/08/2015

Approval date [1]

31/05/2016

Ethics approval number [1]

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

Dr Steve Landers

Address

c/o Barwon Medical Imaging
Barwon Health
PO Box 281
Geelong, Victoria, Australia,
3220

Country

Australia

Phone

+61 3 42150000

Fax

stevel@barwonhealth.org.au

Contact person for public queries

Name

Rachael Hely

Address

c/o Barwon Medical Imaging
Barwon Health
PO Box 281
Geelong, Victoria, Australia
3220

Country

Australia

Phone

+61 3 42150000

Fax

Rachaehe@barwonhealth.org.au

Contact person for scientific queries

Name

Stephen Gill

Address

c/o Barwon Medical Imaging
Barwon Health
PO Box 281
Geelong, Victoria, Australia
3220

Country

Australia

Phone

+61 3 42150000

Fax

steveg@barwonhealth.org.au

Data sharing statement

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

No/undecided IPD sharing reason/comment

The investigators are currently discussing their intentions for data sharing.

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

Source	Title	Year of Publication	DOI
Embase	Genicular Artery Embolization to Improve Pain and Function in Early-Stage Knee Osteoarthritis-24-Month Pilot Study Results.	2020	https://dx.doi.org/10.1016/j.jvir.2020.05.007

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically