Intra-articular Hyalubrix® injections versus local anaesthetic in hip osteoarthritis
| ISRCTN | ISRCTN39397064 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN39397064 |
| Protocol serial number | Q47-04-01 |
| Sponsor | Fidia Farmaceutici S.p.A. (Italy) |
| Funder | Fidia Farmaceutici S.p.A. (Italy) |
- 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
Scientific
Ospedale San Pietro FBF
Via Cassia, 600
Rome
00189
Italy
| albertomigliore@terra.es |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-site prospective randomised double-blind controlled clinical trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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 |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Hyalubrix®, mepivacaine |
| Primary outcome measure(s) |
Determination of the change in the Lequesne index of the hip, comparing IA Hyalubrix® to IA mepivacaine at 26 weeks. |
| Key secondary outcome measure(s) |
Measured 90 and 180 days after first injection: |
| Completion date | 30/06/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 40 |
| 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
00189
Italy
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
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.
