Intra-articular injection of hyaluronic acid (MW 1500-2000 KDa; HyalOne®) in symptomatic osteoarthritis of the hip

Completed

• Conditions: Patients suffering from hip osteoarthritis; Musculoskeletal Diseases; Coxarthrosis

• Registration Number: ISRCTN32694665
• Lead Sponsor: Fidia Farmaceutici S.p.A (Italy)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05-20
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 304

Inclusion Criteria

1. Age > 40 years
2. Hip OA with joint pain of at least one year?s duration
2.1. Symptomatic hip OA according to the American College of Rheumatology (ACR)
2.2. Grade I, II, III or IV hip OA according to the Kellgren-Lawrence classification
2.3. Evaluated on an X-ray taken no more than two months before enrolment

Exclusion Criteria

1. Concomitant use of oral anticoagulant therapy
2. Severe reduction of joint space narrowing evident on X-ray
3. Significant co-morbidities, hypersensitivity to HA or to avian proteins
4. Chronic systemic steroid treatment

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes from baseline to the final visit with respect to Lequesne index

Secondary Outcome Measures

Name	Time	Method
1. Changes from baseline to the final visit with respect to <br>1.1. Visual Analogue Scale (VAS) <br>1.2. Non-steroidal anti-inflammatory drug (NSAID) intake<br>2. Assessment of predictive indices for the response variables (lequesne and VAS indexes)