Study of sodium hyaluronate injections for trapeziometacarpal osteoarthritis
| ISRCTN | ISRCTN83189455 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN83189455 |
| Secondary identifying numbers | Q03-08-01 |
- Submission date
- 23/01/2012
- Registration date
- 22/02/2012
- Last edited
- 14/08/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Hand osteoarthritis (OA) is a common disease, and the trapeziometacarpal joint (TMCJ) is commonly targeted by OA. With respect to the long-term results, Hyaluronic Acid (HA) seems to be the better alternative in the treatment of TMCJ OA, even with a single injection. HA injections were found to be effective in reducing pain and improving fine hand function. The aim of this study was to evaluate the effectiveness of injections of HA for the treatment of pain and disability due to TMCJ OA.
Who can participate?
Patients aged 50 to 80 with symptomatic TMCJ OA treated with Hyaluronic Acid between January 2000 and December 2002.
What does the study involve?
All patients received an injection of Hyaluronic Acid once weekly for three consecutive weeks. Examinations were carried out 1, 3 and 6 months after the first treatment.
What are the possible benefits and risks of participating?
All participants will receive a treatment that may improve pain, radial and palmar abduction, pinch strength, duration of morning stiffness and swelling. There are no known serious risks to participants.
Where is the study run from?
This study has been conducted in the private hospitals Villa Regina, at the rheumatology services , and conducted by Prof. Frizziero as principal investigator.
When is the study starting and how long is it expected to run for?
It is a retrospective study collecting data of patients treated in the period within January 2000 and December 2002.
Who is funding the study?
Hospital Accredited Private Villa Regina [L' Ospedale Privato Accreditato Villa Regina] (Italy).
Who is the main contact?
Dr Nicola Giordan
ngiordan@fidiapharma.it
Contact information
Scientific
Via Rubiani, 2
Bologna
40124
Italy
| luigi.frizziero@libero.it |
Study information
| Study design | Retrospective open-label study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | A retrospective study of intra-articular sodium hyaluronate (MW 500-730 KDa) injections for trapeziometacarpal osteoarthritis |
| Study objectives | The purpose of this retrospective open-label study was to evaluate the efficacy and tolerability of intra-articular injections of HA for the treatment of pain and disability due to trapeziometacarpal joint osteoarthritis. |
| Ethics approval(s) | Local Health Authority of Bologna Ethics Committee for Medical Research, 05/05/2009 |
| Health condition(s) or problem(s) studied | Trapeziometacrpal osteoarthritis |
| Intervention | All patients underwent one cycle of three weekly intra-articular (i.a.) injections of 0.8 mL (10 mg/mL) of Hyalgan® (hyaluronan) (MW 500 730 KDa) using a dorsolateral approach after palpating the joint space. Joints were injected with a 22-gauge needle after preparation with 10% povidone iodine and ethyl chloride local spray. Five visits were scheduled: Visit one: enrolment and start of therapy Visit two: during study treatment Visit three: during study treatment Visit four: during study treatment (1 months after baseline) Visit five: during study treatment (3 months after baseline) Visit six: patient final evaluation (6 months after baseline) |
| Intervention type | Other |
| Primary outcome measure | At baseline and at each subsequent observation times at 1, 3 and 6 months after the treatment, the efficacy and safety parameters were assessed by the investigator and by patients. The following variables were considered and recorded during the visits: 1. Anamnestic and demographic data (only at baseline) 2. Spontaneous pain on movement 3. Provoked pain on movement 4. Pain during night and day 5. Morning stiffness 6. Physicians global assessment 7. Patients global assessment 8. Palmar and radial abduction 9. Pinch strength 10. Nonsteroidal Antiinflammatory Drugs (NSAIDs) intake 11. Tolerability of the product |
| Secondary outcome measures | Local or systemic safety profile of Hyalgan® |
| Overall study start date | 01/01/2000 |
| Completion date | 31/12/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 58 |
| Key inclusion criteria | 1. Patients treated with Hyalgan® in the period within January 2000 and December 2002 2. Patients presenting symptomatic trapeziometacarpal osteoarthritis stated by Kellgren and Lawrence grade scale 3. Patients with at least 6 months of follow-up 4. Patients aged within 50 and 80 years |
| Key exclusion criteria | 1. Arthritic or metabolic pathologies and/or serious trauma 2. Less than 6 months of follow-up 3. Clinically relevant differences in the treatment within enrolled patients |
| Date of first enrolment | 01/01/2000 |
| Date of final enrolment | 31/12/2002 |
Locations
Countries of recruitment
- Italy
Study participating centre
40124
Italy
Sponsor information
Hospital/treatment centre
Rheumatology Services
Via Castiglione 115
Bologna
40100
Italy
| Website | http://www.villaregina-bo.it/ |
|---|---|
"ROR" |
https://ror.org/05gwp6g74 |
Funders
Funder type
Hospital/treatment centre
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 |
