This will be a multi-centre randomized controlled trial, with London Health Sciences Centre (LHSC) as the lead site. Elderly patients with complex ankle fractures who meet the inclusion criteria and provide consent will be randomized (through a web-based randomization system) to one of the two treatment arms. One group (Group A) will receive primary ankle fusion, and the second group (Group B) will receive primary ankle open reduction and internal fixation (ORIF). Patient important outcomes will be compared at one year post injury
The Investigators have amended the study to include a second part for patients with less complicated but still unstable ankle fractures. In this part, patients will be randomly assigned to receive either a procedure called ORIF or another one called retrograde intramedullary fibular nailing.
Severe soft tissue compromise
Significant co-morbidities (vascular disease + chronic trophic changes, diabetes + neuropathy, chronic renal failure, morbid obesity (BMI> 40))
Frailty as defined by a Dalhousie Clinical Frailty Scale score ≥4
None
Ankle fracture patients receiving care at the participating institutions will be eligible for enrolment based on the eligibility criteria.
Other
Prospective
Primary ankle arthrodesis (fusion)
Procedure/SurgeryPrimary arthrodesis: Subjects allocated to the fusion group will have insertion of a retrograde locked calcaneal nail. Tibiotalar joint preparation, bone grafting, subtalar preparation, and fibulectomy will not be performed unless deemed necessary by the treating surgeon.
ORIF (open reduction and internal fixation)
Procedure/SurgeryORIF: ORIF will be performed using modern techniques for timing and staging of fixation, soft tissue and fibula management, surgical approaches, reduction techniques, and plate choice.
Intramedullary Fibular Nailing (IMFN)
Procedure/SurgeryIntramedullary Fibular Nailing: Participants allocated to the IMFN group will receive a locked fibular nail using a previously described technique.
Short-Form 12 (SF-12).
• The primary outcome will be health related quality of life, measured by the SF-12 at one year post surgery. The SF12 measures patient reported, health related quality of life from 0 to 100, with higher scores indicating better physical and mental health functioning.
Numeric Pain Rating Scale
• Pain will be measured on a scale of 0 to 10 with 0 being no pain and 10 being the worst pain imaginable.
Function IndeX (FIX-IT)
• Weight-bearing will be assessed by the FIX-IT score, which provides a simple, standardized and validated approach to assess weight bearing and pain from 0 to 12 with 12 being no pain or weigh-bearing limitations.
Euro-Qol-5 Dimension (EQ5D)
• Health-related quality of life will also be measured by the EQ5D. The EQ5D measures patient-reported health related quality of life from 0 to 100, with 100 being the best health imaginable.
PROMIS-Physical Function Short Form (PROMIS-PF), version 10a
• Patient-reported function will be measured via the PROMIS-PF Short form, a rigorously developed, patient-centred measure that measures functional ability from 10 to 50, with 50 being no functional limitations.
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