M17.9
Conditions
Interventions
Group 1: Patients with symptomatic knee osteoarthritis undergo a single genicular artery embolization using permanent Tris-Acryl Gelatin Microspheres (TAGM
100–300 µm, Embosphere, Merit Medical). Assessment of KOOS (primary endpoint KOOS-Pain) at baseline and at 1, 3, 6, and 12 months. Observation period: 12 months.
Group 2: Patients with symptomatic kn
100–300 µm, Nexsphere-F, NextBiomedical). Assessment of KOOS (primary endpoint KOOS-Pain) at baseline and at 1, 3, 6, and 12 months. Observation period: 12 months.
Sponsors
Universitätsklinikum Düsseldorf
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Knee osteoarthritis with radiographic evidence (Kellgren-Lawrence grade 2–4) Knee pain (Numeric Rating Scale [NRS] > 3), refractory to conservative treatment for more than three months Age = 18 years Capacity to consent and provision of written informed consent
Exclusion criteria
Exclusion criteria: Septic or inflammatory arthritis (e.g., rheumatoid arthritis) Relevant axial malalignment (varus-valgus deviation > 15° on long-leg standing radiographs) Peripheral arterial occlusive disease (> Rutherford grade 3) Known contrast agent allergy Renal impairment (estimated glomerular filtration rate < 30 mL/min/1.73 m²) Contraindications to MRI Planned repeated or bilateral genicular artery embolization during follow-up
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Knee-related pain, assessed using the Pain subscore of the KOOS (Knee injury and Osteoarthritis Outcome Score), determined before therapy (baseline) and at 1, 3, 6, and 12 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Remaining KOOS (Knee injury and Osteoarthritis Outcome Score) subscores – Symptoms, Activities of Daily Living (ADL), Sport and Recreation, Quality of Life – determined before therapy (baseline) and at 6 weeks, 3, 6, and 12 months. Association between the degree of structural knee joint damage on baseline MRI, assessed using individual features of the MOAKS (MRI Osteoarthritis Knee Score; including bone marrow lesion-like features, Hoffa-synovitis, meniscus, cartilage, osteophytes, ligaments), and improvement in the KOOS-Pain subscore at 3 and 12 months. Periprocedural and postprocedural complications, assessed from clinical documentation, during the procedure and throughout the 12-month follow-up period. | — |
Countries
Germany
Contacts
Public ContactPeter Minko
Universitätsklinikum Düsseldorf
Outcome results
None listed