Condition category
Musculoskeletal Diseases
Date applied
14/05/2004
Date assigned
12/07/2004
Last edited
07/12/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.ispm.unibe.ch/research/ongprojects_epstat/sviscot-1.html

Contact information

Type

Scientific

Primary contact

Dr Peter Juni

ORCID ID

Contact details

Departments of Social and Preventive Medicine and Rheumatology
University of Berne
Finkenhubelweg 11
Berne
3012
Switzerland
juni@ispm.unibe.ch

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

SVISCOT-1

Study hypothesis

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

Not provided at time of registration.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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 names

Orthovisc®, Ostenil®, Synvisc®

Primary outcome measures

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 trial start date

01/05/2002

Overall trial end date

31/12/2004

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Not Specified

Gender

Both

Target number of participants

600

Participant exclusion criteria

Not provided at time of registration.

Recruitment start date

01/05/2002

Recruitment end date

31/12/2004

Locations

Countries of recruitment

Switzerland

Trial participating centre

Departments of Social and Preventive Medicine and Rheumatology
Berne
3012
Switzerland

Sponsor information

Organisation

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

Sponsor details

Effingerstrasse 20
Berne
3003
Switzerland

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The manufacturers do not provide any funding for the trial.

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Results in: http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=retrieve&db=pubmed&list_uids=17968921

Publication citations

  1. Results

    Jüni P, Reichenbach S, Trelle S, Tschannen B, Wandel S, Jordi B, Züllig M, Guetg R, Häuselmann HJ, Schwarz H, Theiler R, Ziswiler HR, Dieppe PA, Villiger PM, Egger M, , Efficacy and safety of intraarticular hylan or hyaluronic acids for osteoarthritis of the knee: a randomized controlled trial., Arthritis Rheum., 2007, 56, 11, 3610-3619, doi: 10.1002/art.23026.

Additional files

Editorial Notes