Intra-articular Hyalubrix® injections versus local anaesthetic in hip osteoarthritis

ISRCTN	ISRCTN39397064
DOI	https://doi.org/10.1186/ISRCTN39397064
Secondary identifying numbers	Q47-04-01

Submission date: 06/02/2009
Registration date: 18/02/2009
Last edited: 30/12/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Alberto Migliore
Scientific

Ospedale San Pietro FBF
Via Cassia, 600
Rome
00189
Italy

Email	albertomigliore@terra.es

Study information

Study design	Single-site prospective randomised double-blind controlled clinical trial
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 contact Nicola Giordan at ngiordan@fidiapharma.it to request a patient information sheet
Scientific title	Comparative, double blind, controlled study of intra-articular hyaluronic acid (Hyalubrix®) injections versus local anaesthetic in osteoarthritis of the hip
Study objectives	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(s)	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.
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Hyalubrix®, mepivacaine
Primary outcome measure	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 study start date	09/11/2004
Completion date	30/06/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	40 participants (20 patients for arm)
Total final enrolment	42
Key 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
Key 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
Date of first enrolment	09/11/2004
Date of final enrolment	30/06/2007

Locations

Countries of recruitment

Italy

Study participating centre

Ospedale San Pietro FBF

Rome
00189
Italy

Sponsor information

Fidia Farmaceutici S.p.A. (Italy)
Industry

Via ponte della fabbrica 3/A
Abano Terme
Padova
35031
Italy

Email	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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/12/2009	30/12/2020	Yes	No

Editorial Notes

30/12/2020: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.