Swiss VISCOsupplementation Trial 1

ISRCTN	ISRCTN51421587
DOI	https://doi.org/10.1186/ISRCTN51421587
Secondary identifying numbers	N/A

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Peter Juni
Scientific

Departments of Social and Preventive Medicine and Rheumatology
University of Berne
Finkenhubelweg 11
Berne
3012
Switzerland

Email	juni@ispm.unibe.ch

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Orthovisc®, Ostenil®, Synvisc®
Primary outcome measure	Western Ontario and McMaster Universities osteoarthritis index (WOMAC) pain sub-scores.
Secondary outcome measures	Cost-utility based on health related quality of life measured by EuroQoL and self-reported healthcare utilisation for osteoarthritis
Overall study start date	01/05/2002
Completion date	31/12/2004

Participant type(s)	Patient
Age group	Not Specified
Sex	Both
Target number of participants	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

Departments of Social and Preventive Medicine and Rheumatology

Berne
3012
Switzerland

Swiss Federal Office of Social Insurance (OFAS) (Switzerland)
Government

Effingerstrasse 20
Berne
3003
Switzerland

"ROR"	https://ror.org/03zv4m970

Government

The Swiss Federal Office of Social Insurances (Switzerland) - funding protocol development and implementation

No information available

The manufacturers do not provide any funding for the trial.

No information available

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

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results	01/11/2007		Yes	No