Intraarticular Gold Microparticles for Hip Osteoarthritis

Northern Orthopaedic Division, Denmark

Status: Not yet enrolling

Conditions: Osteoarthritis, Hip

Treatments: Combination Product: Gold

Study type: Observational

Funder types: Other

Identifiers

NCT06186115

ArthroGold-6

Details and patient eligibility

About

In a pilot study, the investigators recently showed that intraarticular metallic gold microparticles reduce knee osteoarthritis pain for up to two years and found associated significant proteomic changes in serum and synovial fluid within eight weeks. This study aim to evaluate the outcome after intra-articular injection of gold microparticles for hip osteoarthritis.

Full description

A cohort of 20 patients, aged ≥ 18 years, with pain ≥ 3 months, and Kellgren-Lawrence OA grade 2-4, will beincluded. Metallic gold 20 mg, 72.000 pieces, 20-40 µ-meter (Berlock-Micro-Implants, HumanGoldInject) (1) were injected into the hip joint using hyaluronic acid as the carrier. In total, we treated 24 hip joints. The primary outcome was the Western Ontario and McMaster Universities Arthritis Index (WOMAC).

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• confirmed moderate hip OA (Kellgren-Lawrence grade ≥ 2), pain for more than 3 months, and maximal pain intensity VAS (Visual Analogue Scale, 0-10) ≥ 5 during the last week

Exclusion criteria

• exclusion criteria were 1) malignancy, 2) active infection and antibiotic treatment, 3) active treatment with steroids, biological or other anti-rheumatic medication, 4) history of chronic pain condition, 5) inability to comply with the protocol, and 6) inadequacy in written and spoken national language.