ISRCTN39397064
Completed
未知
Comparative, double blind, controlled study of intra-articular hyaluronic acid (Hyalubrix®) injections versus local anaesthetic in osteoarthritis of the hip
Fidia Farmaceutici S.p.A. (Italy)0 sites42 target enrollmentFebruary 18, 2009
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Hip osteoarthritis
- Sponsor
- Fidia Farmaceutici S.p.A. (Italy)
- Enrollment
- 42
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
2009 results in https://pubmed.ncbi.nlm.nih.gov/20003205/ (added 30/12/2020)
Investigators
Eligibility 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
- •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
Outcomes
Primary Outcomes
Not specified
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