Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0234098041
Study information
Scientific title
Acronym
Study hypothesis
Comparing two different methods of fixing an anterior cruciate ligament (ACL) graft to the tibia in patients undergoing ACL reconstruction. To identify any difference in knee stability, range of movement or return to pre-injury levels of activity between the two groups.
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
Anterior cruciate ligament (ACL) graft
Intervention
Randomised controlled trial. Patients randomised to one of two methods of fixation of ACL grafts.
Intervention type
Procedure/Surgery
Phase
Not Specified
Drug names
Primary outcome measures
Post operative knee laxity
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/06/2001
Overall trial end date
31/05/2003
Reason abandoned
Eligibility
Participant inclusion criteria
80 Patients undergoing ACL reconstruction.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
80
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
01/06/2001
Recruitment end date
31/05/2003
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Orthopaedic Surgery
Bristol
BS16 1LE
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
Hospital/treatment centre
Funder name
North Bristol 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