Condition category
Musculoskeletal Diseases
Date applied
06/02/2009
Date assigned
18/02/2009
Last edited
18/02/2009
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

Prof Alberto Migliore

ORCID ID

Contact details

Ospedale San Pietro FBF
Via Cassia
600
Rome
00189
Italy
albertomigliore@terra.es

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Q47-04-01

Study information

Scientific title

Comparative, double blind, controlled study of intra-articular hyaluronic acid (Hyalubrix®) injections versus local anaesthetic in osteoarthritis of the hip

Acronym

Study hypothesis

The study compared the benefit, duration and adverse event profile of intra-articular (IA) Hyalubrix® versus IA mepivacaine in the treatment of hip osteoarthritis (OA) using ultrasound-guidance to ensure IA injection.

Ethics approval

The Clinical Study Protocol (CSP) with all its appendices, including informed consent documentation, insurance and Summary of Product Characteristics were submitted for evaluation and approval to the competent Ethic Committee in the involved centre. The study received the favourable opinion by the Ethic Committee on the 9th November 2004.

Study design

Single-site prospective randomised double-blind controlled clinical trial

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 contact Nicola Giordan at ngiordan@fidiapharma.it to request a patient information sheet

Condition

Hip osteoarthritis

Intervention

IA hip injections were guided by ultrasound using an anterosagittal in assistance of real-time ultrasound and Doppler imaging:
Active group: IA injection of Hyalubrix® 4 ml (2 syringes, 60 mg)
Control group: Mepivacaine 4 cc of 2%

Two treatment administrations: one at baseline, and the second one after one month.

Intervention type

Drug

Phase

Not Applicable

Drug names

Hyalubrix®, mepivacaine

Primary outcome measures

Determination of the change in the Lequesne index of the hip, comparing IA Hyalubrix® to IA mepivacaine at 26 weeks.

Secondary outcome measures

Measured 90 and 180 days after first injection:
1. Pain intensity (recorded on a 10 cm VAS)
2. Patient record of non-steroidal anti-inflammatory drug (NSAID) consumption
3. Patients global assessment
4. Examining physician's global assessment
5. Demographic correlations to response
6. Hyaluronic acid (HA) safety

Overall trial start date

09/11/2004

Overall trial end date

30/06/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged greater than 40 years, either sex
2. Ambulant without assistance
3. Hip OA by American College of Rheumatology (ACR) radiographic criteria
4. Baseline Visual Analogue Scale (VAS) score of greater than 4 cm
5. Persistence of hip pain for at least 1 month before baseline
6. Signed informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

40 participants (20 patients for arm)

Participant exclusion criteria

1. Comorbidities (e.g. rheumatoid arthritis, avascular necrosis, fibromyalgia)
2. Infection around the injection site
3. Treatment with oral, parenteral, or IA steroids within 3 months
4. Use of anticoagulants or history of thrombocytopaenia
5. Allergy to local anaesthetics
6. History of adverse reaction to IA Hyalubrix®
7. Pending hip replacement surgery
8. Use of a purported OA disease modifying agent

Recruitment start date

09/11/2004

Recruitment end date

30/06/2007

Locations

Countries of recruitment

Italy

Trial participating centre

Ospedale San Pietro FBF
Rome
00189
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