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Trial registered on ANZCTR


Registration number
ACTRN12624001179527
Ethics application status
Approved
Date submitted
4/09/2024
Date registered
25/09/2024
Date last updated
5/10/2024
Date data sharing statement initially provided
25/09/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Genicular Artery Embolisation (GAE) in Mild to Moderate Osteoarthritis: Correlation between Treatment Effect and Biochemical Biomarkers
Scientific title
Genicular Artery Embolisation (GAE) in Mild to Moderate Osteoarthritis: Correlation between Treatment Effect and Biochemical Biomarkers
Secondary ID [1] 312900 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record
This project is a sub-study of the PRAETORIAN registry (Trial Id: ACTRN12622000621718).

Health condition
Health condition(s) or problem(s) studied:
Knee osteoarthritis 335054 0
Condition category
Condition code
Musculoskeletal 331564 331564 0 0
Osteoarthritis

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This study is a sub-study of a clinical registry called the PRAETORIAN registry (ACTRN12622000621718). It aims to explore the correlation between a series of established biomarkers associated with osteoarthritis (OA) and the data collected as part of the PRAETORIAN registry. The PRAETORIAN registry is designed to collect data on the Genicular Artery Embolisation (GAE) procedure and patient outcomes to assess the safety and efficacy of GAE.

Participants deemed suitable for recruitment into the PRAETORIAN registry will be invited to decide if they would also like to participate in the sub-study. The inclusion and exclusion criteria for the PRAETORIAN registry are as follows:

Inclusion criteria for group A (patients with moderate-to-severe chronic pain following Total Knee Arthroplasty (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 mild-to-severe Knee Osteoarthritis (KOA)):
- Age 40 yrs or older who are willing and able to provide informed consent
- Presence of mild 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)

The data from these two groups are primarily intended to be collected in parallel. However, if notable findings emerge, the outcomes may be compared between the groups in the final analysis.

Participants recruited for this sub-study will be asked to provide blood samples specifically for the purpose of this research at four time points: before their GAE procedure (baseline), and at 1, 6, and 12 months post-GAE procedure.

The collected blood samples will be transferred to the Queensland University of Technology (QUT) for analysis, where they will be used to measure a panel of established biomarkers associated with osteoarthritis. The biomarker levels will be correlated with patient-reported outcomes recorded in the PRAETORIAN registry.

These biomarkers are crucial for understanding the underlying biological processes of osteoarthritis and may reveal important insights into disease progression and treatment efficacy. This additional research seeks to enhance our understanding of the biological mechanisms that drive the patient-reported outcomes observed in the PRAETORIAN registry.
Intervention code [1] 329437 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 339302 0
The primary outcome is the assessment of biomarkers in blood samples.

A diverse set of biomarkers, identified in previous research and potential novel candidates, will be examined through proteomic analysis of serum collected pre- and post-GAE. The main biomarkers to be evaluated include, but are not limited to, CRTAC1 (Cartilage acidic protein 1), Fibrillin-1, Vitamin D-binding Protein, Serpin F1 (Pigment epithelium-derived factor), LGALS1 and LGALS3 (Galectins), CD44, IGFBPs (Insulin-like Growth Factor Binding Proteins), immune-related proteins (such as FCGRT and CEACAM5), C-Reactive Protein, Lysozyme, Prostaglandin D2 Synthase, Complement Component 1q, Complement Component 1r, Complement Component 1q subcomponent C, and pro-inflammatory cytokines (e.g., Interleukin-1 beta (IL-1ß), Tumor Necrosis Factor-alpha (TNF-a), Interleukin-6 (IL-6), Interleukin-15 (IL-15), and Interleukin-17 (IL-17)).
Timepoint [1] 339302 0
Baseline (pre-GAE) and at 1, 6, 12 months post-GAE.
Secondary outcome [1] 439396 0
The assessment of pain levels using patient-reported outcomes recorded in the PRAETORIAN registry questionnaires (ACTRN12622000621718).
Timepoint [1] 439396 0
Baseline (Pre-GAE) and at 1, 6, and 12 months post-GAE.
Secondary outcome [2] 439630 0
Assessment of patient-reported outcomes (PROMs), measured by KOOS-12 (assesses pain, function, and quality of life) questionnaire and recorded in the PRAETORIAN registry (ACTRN12622000621718).
Timepoint [2] 439630 0
Baseline (Pre-GAE) and at 1, 6, and 12 months post-GAE.
Secondary outcome [3] 440104 0
Assessment of overall health status, measured using the EQ-5D-5L questionnaire and recorded in the PRAETORIAN registry (ACTRN12622000621718).
Timepoint [3] 440104 0
Baseline (Pre-GAE) and at 1, 6, and 12 months post-GAE.
Secondary outcome [4] 440105 0
Assessment of current health status, measured using EQ VAS scale and recorded in the PRAETORIAN registry (ACTRN12622000621718).
Timepoint [4] 440105 0
Baseline (Pre-GAE) and at 1, 6, and 12 months post-GAE.
Secondary outcome [5] 440106 0
Assessment of patient-reported outcomes (PROMs), measured by Oxford Knee Score (assesses function and pain) questionnaire and recorded in the PRAETORIAN registry (ACTRN12622000621718).
Timepoint [5] 440106 0
Baseline (Pre-GAE) and at 1, 6, and 12 months post-GAE.
Secondary outcome [6] 440107 0
Assessment of participants’ expectations regarding pain, as recorded in the PRAETORIAN registry (ACTRN12622000621718).
Timepoint [6] 440107 0
Baseline (Pre-GAE) and at 1, 6, and 12 months post-GAE.
Secondary outcome [7] 440108 0
Assessment of participants’ satisfaction following the GAE procedure, as recorded in the PRAETORIAN registry (ACTRN12622000621718).
Timepoint [7] 440108 0
Baseline (Pre-GAE) and at 1, 6, and 12 months post-GAE.
Secondary outcome [8] 440109 0
Assessment of current status of problems associated with knee joint following the GAE procedure, as recorded in the PRAETORIAN registry (ACTRN12622000621718).
Timepoint [8] 440109 0
Baseline (Pre-GAE) and at 1, 6, and 12 months post-GAE
Secondary outcome [9] 440110 0
Assessment of participants’ expectations regarding mobility, as recorded in the PRAETORIAN registry (ACTRN12622000621718).
Timepoint [9] 440110 0
Baseline (Pre-GAE) and at 1, 6, and 12 months post-GAE.
Secondary outcome [10] 440111 0
Assessment of participants’ expectations regarding their health, as recorded in the PRAETORIAN registry (ACTRN12622000621718).
Timepoint [10] 440111 0
Baseline (Pre-GAE) and at 1, 6, and 12 months post-GAE.

Eligibility
Key inclusion criteria
Participants deemed suitable for recruitment into the PRAETORIAN registry will be invited to decide if they would also like to participate in the sub-study. The inclusion and exclusion criteria for the PRAETORIAN registry are as follows, and there are no additional criteria for inclusion in this sub-study beyond those listed for the PRAETORIAN registry.

Inclusion criteria for group A (patients with moderate-to-severe chronic pain following Total Knee Arthroplasty (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 mild-to-severe Knee Osteoarthritis (KOA)):
- Age 40 yrs or older who are willing and able to provide informed consent
- Presence of mild 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
The exclusion criteria are the same as those for the PRAETORIAN registry, with no additional exclusion criteria for this sub-study. The exclusion criteria are as follows:

Exclusion criteria for group A (patients with moderate-to-severe chronic pain following Total Knee Arthroplasty (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 mild-to-severe Knee Osteoarthritis (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
Statistical methods / analysis
Data analysis will involve correlating changes in osteoarthritis biomarkers with clinical outcomes and patient-reported data (pain levels, function, and quality of life) collected from the PRAETORIAN registry (ACTRN12622000621718) at baseline (pre-GAE), and at 1, 6, and 12 months post-GAE. Correlation analyses will be conducted to assess the relationships between biomarker levels, patient-reported outcomes, and clinical measures.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/10/2024
Actual
Date of last participant enrolment
Anticipated
15/11/2025
Actual
Date of last data collection
Anticipated
15/11/2026
Actual
Sample size
Target
70
Accrual to date
0
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 27071 0
The Wesley Hospital - Auchenflower
Recruitment hospital [2] 27072 0
St Andrew's War Memorial Hospital - Brisbane
Recruitment hospital [3] 27073 0
The Prince Charles Hospital - Chermside
Recruitment hospital [4] 27074 0
Sunshine Coast University Private Hospital - Birtinya
Recruitment hospital [5] 27075 0
Pindara Private Hospital - Benowa
Recruitment hospital [6] 27076 0
John Flynn - Gold Coast Private Hospital - Tugun
Recruitment hospital [7] 27077 0
St Andrew's - Ipswich Private Hospital - Ipswich
Recruitment postcode(s) [1] 43139 0
4000 - Brisbane
Recruitment postcode(s) [2] 43140 0
4032 - Chermside
Recruitment postcode(s) [3] 43138 0
4066 - Auchenflower
Recruitment postcode(s) [4] 43142 0
4217 - Benowa
Recruitment postcode(s) [5] 43143 0
4224 - Tugun
Recruitment postcode(s) [6] 43144 0
4305 - Ipswich
Recruitment postcode(s) [7] 43141 0
4575 - Birtinya

Funding & Sponsors
Funding source category [1] 317333 0
Charities/Societies/Foundations
Name [1] 317333 0
Ramsay Hospital Research Foundation
Country [1] 317333 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
I-MED Radiology Network
Address
Country
Australia
Secondary sponsor category [1] 319618 0
None
Name [1] 319618 0
Address [1] 319618 0
Country [1] 319618 0
Other collaborator category [1] 283181 0
University
Name [1] 283181 0
Queensland University of Technology
Address [1] 283181 0
Country [1] 283181 0
Australia
Other collaborator category [2] 283182 0
Individual
Name [2] 283182 0
Dr Brendon May - The Prince Charles Hospital, Pindara Private Hospital &John Flynn Private Hospital
Address [2] 283182 0
Country [2] 283182 0
Australia
Other collaborator category [3] 283188 0
Hospital
Name [3] 283188 0
The Prince Charles Hospital
Address [3] 283188 0
Country [3] 283188 0
Australia
Other collaborator category [4] 283189 0
Hospital
Name [4] 283189 0
Pindara Private Hospital
Address [4] 283189 0
Country [4] 283189 0
Australia
Other collaborator category [5] 283190 0
Hospital
Name [5] 283190 0
John Flynn Private Hospital
Address [5] 283190 0
Country [5] 283190 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316065 0
UnitingCare Health Human Research Ethics Committee
Ethics committee address [1] 316065 0
Ethics committee country [1] 316065 0
Australia
Date submitted for ethics approval [1] 316065 0
10/06/2024
Approval date [1] 316065 0
13/06/2024
Ethics approval number [1] 316065 0
202201

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

Contacts
Principal investigator
Name 136662 0
Dr Brendon May
Address 136662 0
The Prince Charles Hospital, Rode Road, Chermside Queensland 4032
Country 136662 0
Australia
Phone 136662 0
+61409586575
Fax 136662 0
Email 136662 0
brendon.may@health.qld.gov.au
Contact person for public queries
Name 136663 0
Sepinoud Firouzmand
Address 136663 0
I-MED Radiology Network, Wesley Specialist Centre, Level 1, 87 Lang Pde, Auchenflower, QLD 4066
Country 136663 0
Australia
Phone 136663 0
+61 07 3371 9588
Fax 136663 0
Email 136663 0
research@i-med.com.au
Contact person for scientific queries
Name 136664 0
Sepinoud Firouzmand
Address 136664 0
I-MED Radiology Network, Wesley Specialist Centre, Level 1, 87 Lang Pde, Auchenflower, QLD 4066
Country 136664 0
Australia
Phone 136664 0
+61 07 3371 9588
Fax 136664 0
Email 136664 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 individual identifiable participant information will be shared outside the study investigator group. However, de-identified data and results from the cohort may be shared publicly through presentations at conferences, seminars, and publications in academic journals.


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.