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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN48327946
Enrollment
30
Registered
2009-07-21
Start date
2005-07-20
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee osteoarthritis Musculoskeletal Diseases Polyarthrosis

Interventions

The patients, after a complete verbal/questionnaire evaluation, clinical evaluation, anthropometric measurement evaluation (as prescribed by the Davis protocol), and an evaluation with the NRS and WOM
the total duration of treatment was 14 days. The control group was an intra-patient control group: the study product was administered in the OA knee while the controlateral knee was considered as in

Sponsors

Fidia Farmaceutici S.p.A. (Italy)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Improving walking parameters: GAIT Analysis, measured at baseline (T1), and after 45 days (T2).

Secondary

MeasureTime frame
Reducing pain: 1. Western Ontario and McMaster Universities osteoarthritis (OA) index (WOMAC) scale 2. Numerical rating scale Measured at baseline (T1), and after 45 days (T2).

Countries

Italy

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026