Comparative study between intraarticular ostenil versus orthovisc
| ISRCTN | ISRCTN43185756 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN43185756 |
| Secondary identifying numbers | N0237142757 |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 13/02/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English Summary
Not provided at time of registration
Contact information
Mr VS Dachepalli
Scientific
Scientific
St Helens & Knowsley Hospitals NHS Trust
Orthopaedics
Whiston Hospital
Prescot
L35 5DR
United Kingdom
Study information
| Study design | Prospective masked observer randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Comparative study between intraarticular ostenil versus orthovisc |
| 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(s) | Not provided at time of registration |
| Condition | Musculoskeletal Diseases: Osteoarthritis of the knee |
| Intervention | Intraarticular ostenil versus orthovisc |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Ostenil, orthovisc |
| Primary outcome measure | 1. WOMAC - Western Ontario and McMaster Universities Arthritis Index 2. VAS - pain scale |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/05/2004 |
| Overall study end date | 31/12/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Both |
| Target number of participants | 146 |
| Participant inclusion criteria | 1. Male and female 2. Diagnosed with osteoarthritis of the knee |
| 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
- England
- United Kingdom
Study participating centre
St Helens & Knowsley Hospitals NHS Trust
Prescot
L35 5DR
United Kingdom
L35 5DR
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
St Helens and Knowsley Hospitals NHS Trust (UK) NHS R&D Support Funding
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 |
Editorial Notes
13/02/2017: No publications found, verifying study status with principal investigator.
