FRAME Study (Frailty-Related Ankle Fracture Management and Evaluation)

At the current time, there are few prospective studies comparing primary ankle arthrodesis versus Open Reduction and internal fixation (ORIF) for the treatment of complex fractures around the ankle in the frail elderly who have significant co-morbidities.

An effective alternative to ORIF that results in improved function, less post-operative pain and a lower rate of complications is desirable, particularly in the setting of a severely compromised soft tissue envelope, osteopenia or significant co-morbidities. Emerging clinical evidence regarding primary ankle fusion is encouraging, suggesting several potential benefits over ORIF in severely compromised cases including lower post-operative pain scores, improved functional outcomes, lower complication rates, and high union rates. However, high level evidence confirming these potential benefits is lacking. The results of the proposed investigation would have significant implications for the management of orthopaedic trauma patients with fragility fractures around the ankle and may in fact challenge ORIF as the gold standard of treatment in some cases.

Aims \& Hypotheses

Aims:

The Investigators aim to conduct a two-part, multi-center RCT comparing retrograde nailing to ORIF for unstable fractures around the ankle in frail or compromised older adults. The primary research questions are:

Part 1: Does primary ankle fusion with a retrograde tibio-talar-calcaneal hindfoot nail for the treatment of severe fractures around the ankle (tibial pilon AO/OTA type 43 C2-3 or severe ankle fracture \[fracture dislocation, severe joint impaction, severe trimalleolar) in the frail elderly result in improved outcomes and a lower rate of complications compared with ORIF?

Part 2: Does primary retrograde intramedullary fibular nailing (IMFN) result in improved outcomes compared to ORIF for frail older adults with less complex (no dislocation, no significant joint impaction), but unstable fractures(AO/OTA type 44-B2-3, C1-2) around the ankle?

Hypotheses:

The Investigators hypothesize that:

1. Retrograde nailing will result in improved health related quality of life, functional outcomes, pain and reduced complications compared to ORIF. 2. Our null hypothesis is that retrograde nailing will not result in improved post-operative health related quality of life, functional outcomes, pain, and complication rates relative to ORIF for severe fractures around the ankle in the frail elderly.

Study Design

Design:

A two-part, multi-centre randomized clinical trial (RCT)

Procedure: Patients presenting to hospital with a suspected ankle fracture will be screened and those deemed potentially eligible will be approached for consent. Consenting patients will be enrolled prospectively over a 2-year period and followed according to the research ethics board (REB) approved protocol. Patients may also consent to be contacted at 5 years to evaluate long-term changes in outcomes. Full eligibility will be determined by an orthopaedic surgeon, following appropriate radiographic scans. The local research team will measure and capture outcomes during regularly scheduled clinic or hospital visits as well as through email/phone contact for patients consenting to contact via phone/email.

• Numeric Pain Rating Scale [Срок оценки: 1 year post-surgery]
• Function IndeX (FIX-IT) [Срок оценки: 1 year post-surgery]
• Euro-Qol-5 Dimension (EQ5D) [Срок оценки: 1 year post-surgery]
• PROMIS-Physical Function Short Form (PROMIS-PF), version 10a [Срок оценки: 1 year post-surgery]
• Olerud Molander Ankle Score (OMAS) [Срок оценки: 1 year post-surgery]
• Extended Timed-up and Go (TUG) Test [Срок оценки: 1 year post-surgery]
• Rate of complications [Срок оценки: 1 year post-surgery]
• Foot and Ankle Ability Measure (FAAM) [Срок оценки: [Time Frame: 1 year post-surgery]]