Brief Outline

The AIM Trial is a pragmatic, multi-centre, individually randomised controlled equivalence study with parallel prospective economic evaluation.

The trial has been designed to establish whether Close Contact Casting technique (CCC) is clinically equivalent to surgical Open Reduction and Internal Fixation (ORIF) for management of displaced unstable ankle fractures in terms of function, complications, quality of life and patient satisfaction in patients over 60 years of age. CCC will be considered accepted as the effective treatment (i) if the evidence generated by the trial suggests CCC is superior to ORIF or (ii) if the evidence generated by the trial suggests CCC is equivalent to ORIF. This is due to previously demonstrated preference of patients for non-surgical treatments and minimised infection risks.

Participants will be randomised to receive either:

Close Contact Casting technique (CCC)
Open Reduction and Internal Fixation (ORIF)

ORIF is the current standard treatment.

Primary outcome: Patient reported functional outcome score based on the Olerud & Molander Ankle Score at 6 months (post treatment)

Patients are recruited through Trauma and Orthopaedic Surgery Departments of 20 NHS acute hospitals around the UK. The first site went live on 1st July 2010 (the John Radcliffe Hospital in Oxford), and further sites will join the study between July 2010 and end June 2011. It is anticipated that each site will recruit patients for a 36 month period, and will carry out 6 week and 6 month follow up assessments.

AIM is an academic ‘Clinical Research Study’ sponsored by Oxford University and is lead by Professor Keith Willett, Professor of Orthopaedic Trauma Surgery. AIM is funded by the National Institute for Health Research Health Technology Assessment Programme.
The AIM Trial Protocol has full details. To view a copy click here
For a AIM Summary Protocol click here

Relevant Documents
Summary Protocol