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 |
| Secondary identifying numbers | Q47_05_01 |
- 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
| Study design | Randomised intra-patient comparison clinical study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Hyalubrix® |
| Primary outcome measure | Improving walking parameters: GAIT Analysis, measured at baseline (T1), and after 45 days (T2). |
| Secondary outcome measures | 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). |
| Overall study start date | 20/07/2005 |
| Completion date | 11/05/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 30 patients |
| 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
Sponsor information
Fidia Farmaceutici S.p.A. (Italy)
Industry
Industry
Via Ponte della Fabbrica 3/A
Abano Terme - Padova
35031
Italy
| ngiordan@fidiapharma.it | |
| Website | http://www.fidiapharma.it |
"ROR" |
https://ror.org/00dy5wm60 |
Funders
Funder type
Industry
Fidia Farmaceutici S.p.A. (Italy)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
