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

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 designSingle-site prospective randomised double-blind controlled clinical trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please contact Nicola Giordan at ngiordan@fidiapharma.it to request a patient information sheet
Scientific titleComparative, double blind, controlled study of intra-articular hyaluronic acid (Hyalubrix®) injections versus local anaesthetic in osteoarthritis of the hip
Study hypothesisThe 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.
ConditionHip osteoarthritis
InterventionIA 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Hyalubrix®, mepivacaine
Primary outcome measureDetermination of the change in the Lequesne index of the hip, comparing IA Hyalubrix® to IA mepivacaine at 26 weeks.
Secondary outcome measuresMeasured 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 date09/11/2004
Overall study end date30/06/2007

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants40 participants (20 patients for arm)
Total final enrolment42
Participant inclusion criteria1. 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 exclusion criteria1. 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 date09/11/2004
Recruitment end date30/06/2007

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 logo "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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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.