Gait analysis of changes in clinical and biomechanical parameters in osteoarthritis knee patients after intra-articular infiltration with high molecular weight hyaluronic acid (Hyalubrix®)

Completed

• Conditions: Knee osteoarthritis; Musculoskeletal Diseases; Polyarthrosis

• Registration Number: ISRCTN48327946
• Lead Sponsor: Fidia Farmaceutici S.p.A. (Italy)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07-21
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Aged at least 40 years old, either sex
2. Presence of grade 2 or 3 (according to the Kellegren and Lawrence scale) osteoarthritis (OA) of one knee
3. Knee with pain greater than 4 on the Numerical Rating Scale (NRS)

Exclusion Criteria

1. Concurrent presence of pathologies such as rheumatoid arthritis, gout, hip arthritis
2. Presence of skin infections near the knee
3. Use of corticosteroid in the last 3 months
4. Simultaneous anticoagulant therapy
5. Use of joint protective drugs
6. Clotting anomalies
7. Knee valgus
8. Known adverse reactions to hyaluronic acid
9. Presence of knee replacement or impending knee replacement surgery

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improving walking parameters: GAIT Analysis, measured at baseline (T1), and after 45 days (T2).

Secondary Outcome Measures

Name	Time	Method
Reducing pain:<br>1. Western Ontario and McMaster Universities osteoarthritis (OA) index (WOMAC) scale<br>2. Numerical rating scale <br><br>Measured at baseline (T1), and after 45 days (T2).