Contact information
Type
Scientific
Primary contact
Dr N Shaath
ORCID ID
Contact details
Barnsley District General Hospital
Orthipaedics Dept
Gawber Rd
Barnsley
S752EP
United Kingdom
+44 (0)1226 730000
abc@email.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0034162610
Study information
Scientific title
Study of the difference in outcomes between two treatment modalities of the patella in total knee replacement
Acronym
Study hypothesis
To compare the outcomes of two types of surgical procedures used to manage the patella during total knee replacement (TKR) by assessing: anterior knee pain, radiographs of the patella, post-operative range of movement, score as measured by the American Knee Society clinical rating system.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Musculoskeletal Diseases: Total knee replacement (TKR)
Intervention
Randomised prospective study
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measures
To ascertain the outcomes of these two treatment modalities in terms of function. This may lead to a change of practice at BHNFT and nationwide if the results of one procedure are found to be significantly better than the other.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/05/2005
Overall trial end date
01/11/2006
Reason abandoned
Eligibility
Participant inclusion criteria
100 patients (undergoing cemented or uncemented Corin rotaglide total knee replacement to treat osteoarthritis)
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
100
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/05/2005
Recruitment end date
01/11/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Barnsley District General Hospital
Barnsley
S75 2EP
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Barnsley Hospital NHS Foundation 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