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Genicular Artery Embolisation for Knee Osteoarthritis II

NCT05423587 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2024-12-03

No results posted yet for this study

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

Interventions

PROCEDURE

Genicular Artery Embolisation

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

PROCEDURE

Genicular Artery Injection

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

Sponsors & Collaborators

  • Varian, a Siemens Healthineers Company

    lead INDUSTRY

Principal Investigators

  • Mark W Little, MD · Royal Berkshire NHS Foundation Trust, Reading, UK

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-30
Primary Completion
2027-12-31
Completion
2028-06-30

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05423587 on ClinicalTrials.gov