Condition category
Surgery
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
19/10/2011
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 S Anand

ORCID ID

Contact details

Orthopaedics Department
Royal Oldham Hospital
Rochdale Road
Oldham
OL1 2JH
United Kingdom
+44 (0)161 624 0420
sanjeevanand65@hotmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0155126378

Study information

Scientific title

Acronym

Study hypothesis

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

Added July 2008: approved by Oldham Local Ethics Research Committee

Study design

Prospective randomised controlled single blinded single centre trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Surgery: Knee

Intervention

Single post-operative intra-articular injection of sodium hyaluranate vs placebo

Intervention type

Drug

Phase

Not Specified

Drug names

sodium hyaluranate

Primary outcome measures

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 trial start date

10/04/2003

Overall trial end date

31/08/2003

Reason abandoned

Eligibility

Participant inclusion criteria

Male and female patients 18-60 waiting for their arthroscopic knee surgery will be invited to participate.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

25 patients approx

Participant exclusion criteria

1. Infection
2. Inflammatory arthropathy
3. Patellofemoral disease
4. Allergy to Viscoseal

Recruitment start date

10/04/2003

Recruitment end date

31/08/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Orthopaedics Department
Oldham
OL1 2JH
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

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

Funders

Funder type

Government

Funder name

Pennine Acute Hospitals NHS Trust (UK)

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

2004 poster results in http://www.trbchemedica.co.uk/docs/Anand%20OARSI%202004%20poster%20.pdf

Publication citations

Additional files

Editorial Notes