Condition category
Musculoskeletal Diseases
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
07/04/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr VS Dachepalli

ORCID ID

Contact details

St Helens & Knowsley Hospitals NHS Trust
Orthopaedics
Whiston Hospital
Prescot
L35 5DR
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0237142757

Study information

Scientific title

Acronym

Study hypothesis

Which one is most effective in providing short to medium term relief for patients with osteoarthritis of the knee either ostenil or orthovisc, if used as a single course?

Ethics approval

Not provided at time of registration

Study design

Prospective masked observer randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Musculoskeletal Diseases: Osteoarthritis of the knee

Intervention

Intraarticular ostenil versus orthovisc

Intervention type

Drug

Phase

Not Specified

Drug names

ostenil versus orthovisc

Primary outcome measures

1. WOMAC - Western Ontario and McMaster Universities Arthritis Index
2. VAS - pain scale

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/05/2004

Overall trial end date

31/12/2006

Reason abandoned

Eligibility

Participant inclusion criteria

73 patients will be entered in each arm of the trial. Selection of the study group will be from the group of patients diagnosed to have osteoarthritis of the knee. All eligible patients both male and female would be invited to participate. The total number of patients involved will be 146

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

146

Participant exclusion criteria

1. Other known inflammatory arthropathies eg psoriasis, sero-negative arthropathies
2. Grade 4 osteoarthritis on the Kellgren score
3. Previous intra articular injections (except previous steroids or local anaesthetic)
4. Laxity or deformity
5. Uncontrolled diabetes, pregnancy, major existing medical problems, liver and renal diseases
6. Immunosuppressed and those on high dose steroids for any reason
7. Local infection at site and patients with gross pedal oedema
8. Patients with hypersensitivity to hyaluronic acid
9. Patients unwilling to participate or unable to give consent

Recruitment start date

01/05/2004

Recruitment end date

31/12/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

St Helens & Knowsley Hospitals NHS Trust
Prescot
L35 5DR
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

St Helens and Knowsley Hospitals NHS Trust (UK) NHS R&D Support Funding

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

Publication citations

Additional files

Editorial Notes