Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0209181918
Study information
Scientific title
Investigation into patient characteristics and treatment factors associated with short-term and medium-term outcome following Anterior Cruciate Ligament Reconstruction
Acronym
Study hypothesis
What are the factors pre-operatively, intra-operatively and post-operative and related to patient characteristics that have the most influence on outcomes of ACL reconstruction? Particular focus on post operative/rehabilitation factors (knee swelling and initial rehabilitation) and patient psychological factors (adherence to rehabilitation, motivation and sense of control).
Ethics approval
Added 28/08/09:
Joint UCL/UCLH Committees on the Ethics of Human Research (Committee A), Research & Development Directorate, 1st Floor Maple House, 149 Tottenham Court Road, London W1P 9LL. REC reference number: 05/Q0505/120. Meeting date 26th January 2006, approval letter dated 9th February 2006.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Please contact Bruce.Paton@uclh.nhs.uk or Bruce Paton, Extended Scope Practitioner, Physiotherapy Dept., University College Hospital, 235 Euston Road, London NW1 2BU.
Condition
Surgery: Anterior cruciate ligament reconstruction
Intervention
Randomised between 2 groups: normal management vs measures to reduce swelling
Intervention type
Procedure/Surgery
Phase
Not Specified
Drug names
Primary outcome measure
Questionnaire - International Knee Documentation committee (IKDC) form
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/04/2006
Overall trial end date
01/03/2010
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
100 patients recruited from UCLH Foundation Trust, in need of Arthroscopic anterior cruciate ligament reconstruction (ACL) for uncomplicated ACL reconstruction.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
100
Participant exclusion criteria
1. Concurrent surgery (meniscus repair, posterior cruciate ligament reconstruction, other ligament injuries)
2. Patients with gross pre-operative swelling/inflammation, pre-operative loss of normal movement (esp. leg straightening), heavy manual/impact type of work, compulsory return to work before 4 weeks post op).
Recruitment start date
01/04/2006
Recruitment end date
01/03/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Trauma & Orthopaedics
London
NW1 2BU
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2007 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
UCL Hospitals NHS Foundation Trust (UK), NHS R&D Support Funding
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
Basic results (scientific)
Publication list