Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0019113851
Study information
Scientific title
Acronym
Study hypothesis
A prospective randomised study comparing the minimal invasive approach with the standard medical parapatellar approach.
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
Surgery: Knee arthroplasty
Intervention
Minimal invasive approach vs standard medical parapatellar approach
Intervention type
Procedure/Surgery
Phase
Not Applicable
Drug names
Primary outcome measures
Decreased costs, hospital stay, and rehabilitation for patients with unicompartmental prostheses compared with total knee replacement.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/05/2002
Overall trial end date
31/05/2004
Reason abandoned
Eligibility
Participant inclusion criteria
All patients on the waiting list for unicompartmental knee replacement under the care of Consultant Orthopaedic Surgeons Mr Apthorp and Mr Butler-Manuel.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/05/2002
Recruitment end date
31/05/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Conquest Hospital
St Leonard's on Sea
TN37 7RD
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
East Sussex 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