ISRCTN ISRCTN21215727
DOI https://doi.org/10.1186/ISRCTN21215727
Protocol serial number N0155126378
Sponsor Department of Health
Funder Pennine Acute Hospitals NHS Trust (UK)
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

Orthopaedics Department
Royal Oldham Hospital
Rochdale Road
Oldham
OL1 2JH
United Kingdom

Phone +44 (0)161 624 0420
Email sanjeevanand65@hotmail.com

Study information

Primary study designInterventional
Study designProspective randomised controlled single blinded single centre trial
Secondary study designRandomised controlled trial
Study type Participant information sheet
Scientific title
Study objectivesTo 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) studiedSurgery: Knee
InterventionSingle post-operative intra-articular injection of sodium hyaluranate vs placebo
Intervention typeDrug
PhaseNot Specified
Drug / device / biological / vaccine name(s)sodium hyaluranate
Primary outcome measure(s)

Added July 2008:
Pain on weight bearing as measured on 10 point Visual Analogue score.

Key secondary outcome measure(s)

Added July 2008:
1. Pain on rest and squatting, as measured on 10 point Visual Analogue score
2. SF-12 and WOMAC score

Completion date31/08/2003

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit60 Years
SexAll
Target sample size at registration25
Key inclusion criteriaMale and female patients 18-60 waiting for their arthroscopic knee surgery will be invited to participate.
Key exclusion criteria1. Infection
2. Inflammatory arthropathy
3. Patellofemoral disease
4. Allergy to Viscoseal
Date of first enrolment10/04/2003
Date of final enrolment31/08/2003

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

Orthopaedics Department
Oldham
OL1 2JH
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot 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
Poster results poster results 02/12/2004 No No