Cookies on this website
We use cookies to ensure that we give you the best experience on our website. If you click 'Continue' we'll assume that you are happy to receive all cookies and you won't see this message again. Click 'Find out more' for information on how to change your cookie settings.

This was a pragmatic, multi-centre, individually randomised controlled equivalence study with parallel prospective economic evaluation comparing close contact casting technique (CCC) to open reduction and Internal Fixation (ORIF) for patients over 60 years of age with unstable ankle fractures.

BRIEF SUMMARY:

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)
or
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)


The study protocol publication can be found here https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4234276/

 

The results can be found here http://jamanetwork.com/journals/jama/fullarticle/2565749

 

The JAMA Editorial on the results can be found here http://jamanetwork.com/journals/jama/fullarticle/2565734?resultClick=1

 

The Full HTA Report is here https://www.ncbi.nlm.nih.gov/pubmed/27735787


Our team