Hip osteoarthritis Musculoskeletal Diseases Coxarthrosis
Conditions
Interventions
IA hip injections were guided by ultrasound using an anterosagittal in assistance of real-time ultrasound and Doppler imaging:
Active group: IA injection of Hyalubrix® 4 ml (2 syringes
Sponsors
Fidia Farmaceutici S.p.A. (Italy)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged greater than 40 years, either sex 2. Ambulant without assistance 3. Hip OA by American College of Rheumatology (ACR) radiographic criteria 4. Baseline Visual Analogue Scale (VAS) score of greater than 4 cm 5. Persistence of hip pain for at least 1 month before baseline 6. Signed informed consent
Exclusion criteria
Exclusion criteria: 1. Comorbidities (e.g. rheumatoid arthritis, avascular necrosis, fibromyalgia) 2. Infection around the injection site 3. Treatment with oral, parenteral, or IA steroids within 3 months 4. Use of anticoagulants or history of thrombocytopaenia 5. Allergy to local anaesthetics 6. History of adverse reaction to IA Hyalubrix® 7. Pending hip replacement surgery 8. Use of a purported OA disease modifying agent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determination of the change in the Lequesne index of the hip, comparing IA Hyalubrix® to IA mepivacaine at 26 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Measured 90 and 180 days after first injection: 1. Pain intensity (recorded on a 10 cm VAS) 2. Patient record of non-steroidal anti-inflammatory drug (NSAID) consumption 3. Patients global assessment 4. Examining physician's global assessment 5. Demographic correlations to response 6. Hyaluronic acid (HA) safety | — |
Countries
Italy
Outcome results
None listed