Condition category
Musculoskeletal Diseases
Date applied
26/05/2009
Date assigned
21/07/2009
Last edited
21/07/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Cristina Smiderle

ORCID ID

Contact details

Department of Physical Medicine and Rehabilitation
“S.Bassiano” Hospital
Bassano del Grappa
Vicenza
36061
Italy

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Q47_05_01

Study information

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

Acronym

Study hypothesis

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

Ethics Committee of San Bassiano Hospital approved on the 20th July 2005

Study design

Randomised intra-patient comparison clinical study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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 names

Hyalubrix®

Primary outcome measures

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 trial start date

20/07/2005

Overall trial end date

11/05/2009

Reason abandoned

Eligibility

Participant 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)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

30 patients

Participant 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

Recruitment start date

20/07/2005

Recruitment end date

11/05/2009

Locations

Countries of recruitment

Italy

Trial participating centre

Department of Physical Medicine and Rehabilitation
Bassano del Grappa, Vicenza
36061
Italy

Sponsor information

Organisation

Fidia Farmaceutici S.p.A. (Italy)

Sponsor details

Via Ponte della Fabbrica 3/A
Abano Terme - Padova
35031
Italy
ngiordan@fidiapharma.it

Sponsor type

Industry

Website

http://www.fidiapharma.it

Funders

Funder type

Industry

Funder name

Fidia Farmaceutici S.p.A. (Italy)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes