Intra-articular Hyalubrix® injections versus local anaesthetic in hip osteoarthritis
ISRCTN | ISRCTN39397064 |
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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
Scientific
Ospedale San Pietro FBF
Via Cassia, 600
Rome
00189
Italy
albertomigliore@terra.es |
Study information
Study design | Single-site prospective randomised double-blind controlled clinical trial |
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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 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(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. |
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 |
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 |
Overall study end date | 30/06/2007 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Both |
Target number of participants | 40 participants (20 patients for arm) |
Total final enrolment | 42 |
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 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
Study participating centre
Ospedale San Pietro FBF
Rome
00189
Italy
00189
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 |
https://ror.org/00dy5wm60 |
Funders
Funder type
Industry
Fidia Farmaceutici S.p.A. (Italy)
No information available
Results and Publications
Intention to publish date | |
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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.