Effect of sodium hyaluranate on recovery after arthroscopic knee surgery
| ISRCTN | ISRCTN21215727 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN21215727 |
| Secondary identifying numbers | N0155126378 |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 19/10/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr S Anand
Scientific
Scientific
Orthopaedics Department
Royal Oldham Hospital
Rochdale Road
Oldham
OL1 2JH
United Kingdom
| Phone | +44 (0)161 624 0420 |
|---|---|
| sanjeevanand65@hotmail.com |
Study information
| Study design | Prospective randomised controlled single blinded single centre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | |
| Study objectives | To determine effect of single post-operative intra-articular injection of sodium hyaluranate on the pain and joint function following arthroscopic knee surgery. |
| Ethics approval(s) | Added July 2008: approved by Oldham Local Ethics Research Committee |
| Health condition(s) or problem(s) studied | Surgery: Knee |
| Intervention | Single post-operative intra-articular injection of sodium hyaluranate vs placebo |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | sodium hyaluranate |
| Primary outcome measure | Added July 2008: Pain on weight bearing as measured on 10 point Visual Analogue score. |
| Secondary outcome measures | Added July 2008: 1. Pain on rest and squatting, as measured on 10 point Visual Analogue score 2. SF-12 and WOMAC score |
| Overall study start date | 10/04/2003 |
| Completion date | 31/08/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 60 Years |
| Sex | Both |
| Target number of participants | 25 patients approx |
| Key inclusion criteria | Male and female patients 18-60 waiting for their arthroscopic knee surgery will be invited to participate. |
| Key exclusion criteria | 1. Infection 2. Inflammatory arthropathy 3. Patellofemoral disease 4. Allergy to Viscoseal |
| Date of first enrolment | 10/04/2003 |
| Date of final enrolment | 31/08/2003 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Orthopaedics Department
Oldham
OL1 2JH
United Kingdom
OL1 2JH
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.dh.gov.uk/Home/fs/en |
|---|
Funders
Funder type
Government
Pennine Acute Hospitals NHS Trust (UK)
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Poster results | poster results | 02/12/2004 | No | No |
