Gait analysis of changes in clinical and biomechanical parameters in osteoarthritis knee patients after intra-articular infiltration with high molecular weight hyaluronic acid (Hyalubrix®)
| ISRCTN | ISRCTN48327946 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN48327946 |
| Protocol serial number | Q47_05_01 |
| Sponsor | Fidia Farmaceutici S.p.A. (Italy) |
| Funder | Fidia Farmaceutici S.p.A. (Italy) |
- Submission date
- 26/05/2009
- Registration date
- 21/07/2009
- Last edited
- 21/07/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Cristina Smiderle
Scientific
Scientific
Department of Physical Medicine and Rehabilitation
S.Bassiano Hospital
Bassano del Grappa, Vicenza
36061
Italy
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised intra-patient comparison clinical study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | 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 |
| Study objectives | The goal of the research was to evaluate, in osteoarthritis of the knee patients, the efficacy of intra-articular high molecular weight hyaluronic acid (Hyalubrix®) with the use of gait analysis analysing both kinematics and kinetic parameters. |
| Ethics approval(s) | Ethics Committee of San Bassiano Hospital approved on the 20th July 2005 |
| Health condition(s) or problem(s) studied | Knee osteoarthritis |
| Intervention | 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 WOMAC scales, underwent the first round of gait analysis (T1). On the same day, after the instrumental analysis, the patients were given the first infiltration with hyaluronic acid: patients received three intra-articular injections once a week; 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 intra-patient control group. After 45 days from the first evaluation, the patients were assessed again with the NRS and WOMAC scales, and gait analysis. |
| Intervention type | Drug |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Hyalubrix® |
| Primary outcome measure(s) |
Improving walking parameters: GAIT Analysis, measured at baseline (T1), and after 45 days (T2). |
| Key secondary outcome measure(s) |
Reducing pain: |
| Completion date | 11/05/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 30 |
| Key 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) |
| Key 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 |
| Date of first enrolment | 20/07/2005 |
| Date of final enrolment | 11/05/2009 |
Locations
Countries of recruitment
- Italy
Study participating centre
Department of Physical Medicine and Rehabilitation
Bassano del Grappa, Vicenza
36061
Italy
36061
Italy
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
