Genicular Artery Embolisation for Knee Osteoarthritis II

ConditionKnee Osteoarthritis

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age45+

SponsorVarian, a Siemens Healthineers Company

About this trial

This clinical study is designed as a double-blind sham controlled randomised trial with the option of sham group crossover to receive the GAE treatment at 6 months after unblinding. This study will determine if embolisation of abnormal neovasculature arising from branches of the genicular arteries reduces pain in patients with knee osteoarthritis. The study patient population will consist of up to 110 subjects with knee pain for at least 3 months that is resistant to conservative treatment measures. Subjects will be treated with knee embolisation or 2 mL of saline in the sham arm. At 6 months, all subjects in the sham arm will be allowed to cross-over and receive the embolisation procedure with a follow-up duration of 18 months. The total planned study duration is 3.5 years.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participant is willing and able to give informed consent for participation in the study.

Participants aged 45 years or above.

Grade 1-3 knee OA on X-ray as per Kellgren-Lawrence Grading Scale

Knee pain for at least 3 months resistant to conservative non-surgical treatment (e.g., physiotherapy, steroid injections, weight loss programs, PRP (platelet-rich plasma) injections)

Disqualifiers

Rheumatoid arthritis or infectious arthritis

Severe knee OA (grade 4 on x-ray as per Kellgren-Lawrence Grade)

Renal impairment: eGFR <45. Assessed from medical records or a blood test if required as is part of standard clinical practice when considering a patient for a therapeutic intervention.

Patients with a bleeding diathesis, or other bleeding risk such as patients on warfarin which cannot be stopped easily (e.g., patients with metallic heart valves) assessed by asking the patient and from medical records. Uncorrectable bleeding diathesis: INR>1.6, Platelets <50,000

Trial design

Design model

Crossover

Treatments tested in this trial

Genicular Artery Embolisation
Procedure/Surgery
Transarterial catheter directed embolisation of hypervascularity in patients with mild to moderate knee osteoarthritis
Genicular Artery Injection
Procedure/Surgery
Transarterial catheter directed injection of normal (0.9%) saline in patients with mild to moderate knee osteoarthritis

Treatment groups

110 Participants

are divided into 2 treatment groups

Group A: GAE TreatmentExperimental treatment 1 intervention

Group B: Sham ProcedureSham comparator 1 intervention

Trial outcomes

Primary outcomes

Determine if embolisation of abnormal neovasculature arising from branches of the genicular arteries reduces pain in patients with knee OA compared to Sham treatment

Change from baseline to 6 months post randomisation in the mean score on four Knee Injury and Osteoarthritis Outcome Score subscales, covering pain, symptoms, activities of daily living, and quality of life (KOOS4); scores range from 0 (worst) to 100 (best)

Time frame

6 months

Secondary outcomes

Determine clinical success

The proportion of subjects reporting at least a 10- point improvement in KOOS scores at 6-months (where a 10-point change from baseline is defined as the minimum clinically important difference (MCID)

Time frame

6 months

Assessment of pain relief

Pain relief at 6 months post randomisation, using the patient-reported 0 - 100 visual analogue scale (VAS) pain score

Time frame

6 months

Determine if embolisation improves pain, function, and quality of life in patients with knee OA compared to Sham treatment

All 5 subscales of the KOOS questionnaire will be analysed at 6 months post randomisation.

Time frame

6 months

Other outcomes

Determine safety and toxicity

Proportion of subjects experiencing relevant adverse events (as per SIR Adverse Event Classification System) at 6 months post randomisation

Time frame

6 months follow-up

Determine if improvement of knee osteoarthritis can be described by imaging analysis following GAE vs Sham

Whole Organ Magnetic Resonance Imaging Score (WORMS) for non-invasive assessment of synovial hypertrophy and neo-vascularization for osteoarthritis at 6 months post randomisation.

Time frame

6 months

Quantification of a personalised psychometric pain profile to determine whether treatment response can be predicted using behavioural indicators of predisposition to central facilitation of pain

Pain Catastrophizing Scale (PCS) patient questionnaire: Score reflects on painful experiences of the patient. Score from 0 (minimum) to 52 (maximum). A higher score means worse outcome

Time frame

6 months

Determine quality of life changes

Changes in quality of life measured by Euro-Quality of Life-5D-3L (EQ-5D-3L) assessing five dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression), each having three levels (3L): no problems, some problems, extreme problems (labelled 1-3) in a descriptive fashion.

Time frame

6 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Varian, a Siemens Healthineers Company

Lead sponsor

Source ClinicalTrials.gov

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