Swiss VISCOsupplementation Trial 1
| ISRCTN | ISRCTN51421587 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN51421587 |
| Protocol serial number | N/A |
| Sponsor | Swiss Federal Office of Social Insurance (OFAS) (Switzerland) |
| Funders | The Swiss Federal Office of Social Insurances (Switzerland) - funding protocol development and implementation, The manufacturers do not provide any funding for the trial. |
- Submission date
- 14/05/2004
- Registration date
- 12/07/2004
- Last edited
- 07/12/2007
- 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
Dr Peter Juni
Scientific
Scientific
Departments of Social and Preventive Medicine and Rheumatology
University of Berne
Finkenhubelweg 11
Berne
3012
Switzerland
| juni@ispm.unibe.ch |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | SVISCOT-1 |
| Study objectives | To determine the comparative effectiveness, cost-utility and safety of preparations with different chemical structures and origins used for viscosupplementation in knee Osteoarthritis (OA). |
| Ethics approval(s) | Not provided at time of registration. |
| Health condition(s) or problem(s) studied | Osteoarthritis (OA) of the knee |
| Intervention | Patients will be allocated to one of three different preparations, a cross-linked formulation (Synvisc®) and non-cross-linked preparations of different origin (Orthovisc® and Ostenil®). Patients will undergo up to three treatment cycles per knee (one cycle consisting of three injections), with not more than one treatment cycle per knee every 6 months and the last injection administered not later than 18 months post-randomisation. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Orthovisc®, Ostenil®, Synvisc® |
| Primary outcome measure(s) |
Western Ontario and McMaster Universities osteoarthritis index (WOMAC) pain sub-scores. |
| Key secondary outcome measure(s) |
Cost-utility based on health related quality of life measured by EuroQoL and self-reported healthcare utilisation for osteoarthritis |
| Completion date | 31/12/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | All |
| Target sample size at registration | 600 |
| Key inclusion criteria | 1. Men and non-pregnant women with radiologically confirmed symptomatic OA of the knee for at least 6 months 2. Pain on most days for the previous 3 months 3. Fulfil American College of Rheumatology (ACR) clinical criteria for OA of the knee: 3.1. Have an ACR functional class rating of II to IV 3.2. Failed to respond sufficiently 3.3. Intolerant to conservative treatment |
| Key exclusion criteria | Not provided at time of registration. |
| Date of first enrolment | 01/05/2002 |
| Date of final enrolment | 31/12/2004 |
Locations
Countries of recruitment
- Switzerland
Study participating centre
Departments of Social and Preventive Medicine and Rheumatology
Berne
3012
Switzerland
3012
Switzerland
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 | 01/11/2007 | Yes | No | |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
