Intra-articular Hyalubrix® injections versus local anaesthetic in hip osteoarthritis

Not Applicable

Completed

• Conditions: Hip osteoarthritis; Musculoskeletal Diseases; Coxarthrosis

• Registration Number: ISRCTN39397064
• Lead Sponsor: Fidia Farmaceutici S.p.A. (Italy)

Brief Summary

2009 results in https://pubmed.ncbi.nlm.nih.gov/20003205/ (added 30/12/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2007-06-30
• Study Start: 2009-02-18
• Last Update Posted: 11 January 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 42

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Determination of the change in the Lequesne index of the hip, comparing IA Hyalubrix® to IA mepivacaine at 26 weeks.

Secondary Outcome Measures

Name	Time	Method
<br> Measured 90 and 180 days after first injection:<br> 1. Pain intensity (recorded on a 10 cm VAS)<br> 2. Patient record of non-steroidal anti-inflammatory drug (NSAID) consumption<br> 3. Patients global assessment<br> 4. Examining physician's global assessment<br> 5. Demographic correlations to response<br> 6. Hyaluronic acid (HA) safety<br>