Genicular Artery Embolisation for Knee Osteoarthritis II

NCT05423587 | Recruiting

• 2 other identifiers: VAR-2021-11286849
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Knee Osteoarthritis

Keywords

Microspheres; Embozene; Artery Embolization; Joint diseases; Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (1)

• 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)

  6 months

Secondary Outcomes (3)

• Determine clinical success

  6 months

• Assessment of pain relief

  6 months

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

  6 months

Other Outcomes (40)

• Determine safety and toxicity

  6 months follow-up

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

  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

  6 months

Study Arms (2)

GAE Treatment

EXPERIMENTAL

The genicular artery embolisation procedure identifies abnormal blood vessels in the knee via angiogram imaging. Through groin access and puncture of the femoral artery through a small sheath tiny microspheres (Embozene(TM)) will be injected into this area and reduce blood flow in order to reduce pain.

Procedure: Genicular Artery Embolisation

Sham Procedure

SHAM COMPARATOR

In the control (sham) arm patients will not undergo the embolisation procedure with microspheres, instead they will have 2ml of saline injected into their knee artery supplying the abnormal area of the knee. The remainder of the procedure is otherwise identical between the two groups.

Procedure: Genicular Artery Injection

Interventions

Genicular Artery Embolisation PROCEDURE

Transarterial catheter directed embolisation of hypervascularity in patients with mild to moderate knee osteoarthritis

Also known as: Embozene Microspheres, Embozene

GAE Treatment

Genicular Artery Injection PROCEDURE

Transarterial catheter directed injection of normal (0.9%) saline in patients with mild to moderate knee osteoarthritis

Sham Procedure

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• Be able to lie flat for at least 6 hours-this will be assessed by asking how participants sleep (bed, chair recumbent, semi-recumbent) and assessing what prevents them from lying flat overnight (breathlessness, back pain, etc)
• Minimum score of 50 on baseline 0 - 100 VAS

You may not qualify if:

• The patient may not enter the study if ANY of the following apply:
• 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
• Requires oxygen on ambulation. Assessed by asking the patient and from medical records.
• Low life expectancy (\<1 year)
• Communication difficulty due to language barriers
• Contraindication to MRI
• Known allergies to barium sulfate, 3-aminopropyltrialkoxysilane, polyphosphazene or IV radiopaque contrast agent
• History of Peripheral Arterial Disease (PAD) with intermittent claudication and/or rest pain
• Pregnancy or positive pregnancy test (the participant will be exposed to ionising radiation during the fluoroscopy procedure)
• Any other significant disease or disorder which, in the opinion of the recruiting physician, may put the participants at risk because of participation in the study, or may influence the result of the study or the participant's ability to participate

Sponsors & Collaborators

• Varian, a Siemens Healthineers Company: lead

Study Sites (1)

Royal Berkshire NHS Foundation Trust

Reading, RG1 5AN, United Kingdom

RECRUITING

Related Publications (1)

• Little MW, Harrison R, MacGill S, Speirs A, Briggs JH, Tayton E, Davies NLC, Hausen HS, McCann C, Levine LL, Sharma RA, Gibson M. Genicular Artery Embolisation in Patients with Osteoarthritis of the Knee (GENESIS 2): Protocol for a Double-Blind Randomised Sham-Controlled Trial. Cardiovasc Intervent Radiol. 2023 Sep;46(9):1276-1282. doi: 10.1007/s00270-023-03477-z. Epub 2023 Jun 19.

  PMID: 37337060 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee; Joint Diseases

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Mark W Little, MD

  Royal Berkshire NHS Foundation Trust, Reading, UK

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Heike S Hausen, MD

CONTACT

2068903102; Heike.Hausen@varian.com

Kate Pietrovito

CONTACT

+19782908408; Kathleen.Pietrovito@varian.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: A randomization algorithm (hidden and protected) allocates a random number to each of the 110 subjects. The outputs of this algorithm will only be accessible to those who are unrestricted by experimental blinding (operator, radiographer, scrub nurse). For safety reasons the interventional radiologist will be aware of the treatment arm (non-blind).
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single Site, Double Blind Sham Randomized Controlled Trial with Sham subject optional crossover to the treatment arm (GAE) at 6 months post randomization to determine if embolization of abnormal blood vessels arising from branches of the genicular arteries reduces pain in patients with knee osteoarthritis.

Study Record Dates

• First Submitted: April 11, 2022
• First Posted: June 21, 2022
• Study Start: October 30, 2022
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: December 3, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)