Investigation into patient characteristics and treatment factors associated with short-term and medium-term outcome following Anterior Cruciate Ligament Reconstruction

ISRCTN ISRCTN30554985
DOI https://doi.org/10.1186/ISRCTN30554985
Secondary identifying numbers N0209181918
Submission date
28/09/2007
Registration date
28/09/2007
Last edited
23/05/2016
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Fares S Haddad
Scientific

Department of Trauma & Orthopaedics
University College Hospital
235 Euston Road
London
NW1 2BU
United Kingdom

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant 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.
Scientific titleInvestigation into patient characteristics and treatment factors associated with short-term and medium-term outcome following Anterior Cruciate Ligament Reconstruction
Study objectivesWhat 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(s)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.
Health condition(s) or problem(s) studiedSurgery: Anterior cruciate ligament reconstruction
InterventionRandomised between 2 groups: normal management vs measures to reduce swelling
Intervention typeProcedure/Surgery
Primary outcome measureQuestionnaire - International Knee Documentation committee (IKDC) form
Secondary outcome measuresNot provided at time of registration
Overall study start date01/04/2006
Completion date01/03/2010

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants100
Key inclusion criteria100 patients recruited from UCLH Foundation Trust, in need of Arthroscopic anterior cruciate ligament reconstruction (ACL) for uncomplicated ACL reconstruction.
Key exclusion criteria1. 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).
Date of first enrolment01/04/2006
Date of final enrolment01/03/2010

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Department of Trauma & Orthopaedics
London
NW1 2BU
United Kingdom

Sponsor information

Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Government

The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email dhmail@doh.gsi.org.uk
Website http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

UCL Hospitals NHS Foundation Trust (UK), NHS R&D Support Funding

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Editorial Notes

23/05/2016: No publications found, verifying study status with principal investigator