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Anterior Cruciate Ligament (ACL) Reconstruction using two different types of Femoral Fixation i.e. Mitec Rigidfix femoral polylactide (PLA) cross pin and the Anthrex Bio Transfix implant
ISRCTN ISRCTN80878260
ClinicalTrials.gov identifier
Public title Anterior Cruciate Ligament (ACL) Reconstruction using two different types of Femoral Fixation i.e. Mitec Rigidfix femoral polylactide (PLA) cross pin and the Anthrex Bio Transfix implant
Scientific title
Acronym N/A
Serial number at source N0020129460
Study hypothesis Is there any difference in the outcome of the ACL reconstruction using two types of femoral fixation?
Lay summary
Ethics approval Not provided at time of registration
Study design Randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Surgery: Anterior cruciate ligament reconstruction
Participants - inclusion criteria 100 ligament reconstruction patients
Participants - exclusion criteria Not provided at time of registration
Anticipated start date 01/09/2003
Anticipated end date 01/09/2006
Status of trial Completed
Patient information material
Target number of participants 100 patients - 50 in each group
Interventions Patients with ACL deficiency to be reconstructed using hamstring graft (4 strands) with two types of fixture.
Primary outcome measure(s) International Knee Documentation Committee (IKDC) scoring system - tagner scoring system
Secondary outcome measure(s) Not provided at time of registration
Sources of funding Barking, Havering and Redbridge Hospitals NHS Trust (UK)
Trial website
Publications
Contact name Mr  Ahmad  Ali
  Address Orthopaedic Consultant Surgeon
Orthopaedics
Oldchurch Hospital
  City/town Romford
  Zip/Postcode RM7 0BE
  Country United Kingdom
  Tel +44 (0)1708 708 478
  Fax +44 (0)1708 708 477
  Email amali@rcsed.ac.uk
Sponsor Record Provided by the NHSTCT Register - 2004 Update - Department of Health (UK)
  Address The Department of Health,
Richmond House,
79 Whitehall
  City/town London
  Zip/Postcode SW1A 2NL
  Country United Kingdom
  Tel +44 (0)20 7307 2622
  Email dhmail@doh.gsi.org.uk
  Sponsor website: http://www.dh.gov.uk/Home/fs/en
Date applied 30/09/2004
Last edited 13/04/2011
Date ISRCTN assigned 30/09/2004
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