About this trial
The investigators have shown in three pilot studies that intra-articular metallic gold microparticles can reduce knee osteoarthritis pain for up to two years. These results are noteworthy considering the growing number of older adults who suffer from osteoarthritis pain, which contributes to increased demand on healthcare resources. Demonstrating effective treatment could alleviate this burden for a significant portion of the aging population.
The specific aim is to evaluate whether intra-articular metallic gold microparticles are superior to placebo in reducing the need for additional treatment in patients with knee osteoarthritis within one year. The investigators will test the hypothesis that intra-articular metallic gold microparticles reduce subsequent treatment events by more than 50% compared to placebo during this period.
Eligibility criteria
Qualifiers
more than 6 months of knee pain without efficacy on pain of conservative treatment, radiographic knee osteoarthritis according to Kellgren-Lawrence grade 1-4, and age ≥18years
Disqualifiers
malalignment, indication for knee replacement surgery, malignancy, active infection and antibiotic treatment, active treatment with steroids, biological or other anti-Rheumatic medication, inability to comply with the protocol, inadequacy in the written and spoken national language
Trial design
Treatments tested in this trial
- 20 mg metallic gold microparticles (72.000 particles, 20-40 µm) will be injected into the knee joint using 2 mL hyaluronic acid.
- Intervention
Treatment groups
Locations
Sponsors and collaborators
Northern Orthopaedic Division, Denmark
Lead sponsor
Aalborg University Hospital
Sponsor institution
Aalborg University
Collaborator