Ankle Injury Management (AIM): design of a pragmatic multi-centre equivalence randomised controlled trial comparing Close Contact Casting (CCC) to Open surgical Reduction and Internal Fixation (ORIF) in the treatment of unstable ankle fractures in patients over 60 years

Table 1 Outcome measures by time-point for the AIM study

Outcome	Baseline assessments	Theatre	6 weeks	6 months (Outcome assessor blinded)
Olerud & Molander ankle score	+ (prior to injury status)		+	+
EQ-5D	+ (day before injury status and on the day of assessment)		+	+
SF-12	+ (prior to injury status)		+	+
General health - medical history, smoking, alcohol intake, allergies and medication	+
Social circumstances - place of residence, mobility status and care requirements	+
Ankle range of movement - goniometer measurement of dorsiflexion, plantarflexion, inversion and eversion, uninjured and injured ankles.			+	+
Radiological measurements of fracture and ankle joint congruence		+	+	+
Theatre procedure data - Time in and out of theatre, experience of operating surgeon, implants used, type of anaesthetic, complications		+
Patient satisfaction measure - 2 questions (Likert-type scale)			+	+
Health economics questionnaire			+	+
Timed ‘Get up and Go’ test				+

ISSN: 1471-2474