Comparative study between intraarticular ostenil versus orthovisc
| ISRCTN | ISRCTN43185756 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN43185756 |
| Protocol serial number | N0237142757 |
| Sponsor | Department of Health |
| Funder | St Helens and Knowsley Hospitals NHS Trust (UK) NHS R&D Support Funding |
- 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 of protocol
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
| Primary study design | Interventional |
|---|---|
| Study design | Prospective masked observer randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Comparative study between intraarticular ostenil versus orthovisc |
| Study objectives | 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 |
| Health condition(s) or problem(s) studied | Musculoskeletal Diseases: Osteoarthritis of the knee |
| Intervention | Intraarticular ostenil versus orthovisc |
| Intervention type | Drug |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Ostenil, orthovisc |
| Primary outcome measure(s) |
1. WOMAC - Western Ontario and McMaster Universities Arthritis Index |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/12/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | All |
| Target sample size at registration | 146 |
| Key inclusion criteria | 1. Male and female 2. Diagnosed with osteoarthritis of the knee |
| Key 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 |
| Date of first enrolment | 01/05/2004 |
| Date of final enrolment | 31/12/2006 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
St Helens & Knowsley Hospitals NHS Trust
Prescot
L35 5DR
United Kingdom
L35 5DR
United Kingdom
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? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
13/02/2017: No publications found, verifying study status with principal investigator.
