RecruitingNCT05131321

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

FRAME Study (Frailty-Related Ankle Fracture Management and Evaluation): Retrograde Nailing Versus Open Reduction and Internal Fixation for Unstable Fractures Around the Ankle in the Frail Elderly - A Two-Part Prospective, Randomized, Multi-Center Clinical Trial

Sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Enrollment

172 participants

Start Date

Apr 21, 2022

Study Type

OBSERVATIONAL

Conditions

Ankle Fractures Pilon Fracture

Summary

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.

Eligibility

Min Age: 40 Years

Inclusion Criteria5

(i) Age ≥ 60 years (ii) One or more of the following:
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
(i) Isolated fracture (within 4 weeks of injury): an AO/OTA type 43C2 or C3 tibial pilon fracture or severe ankle fracture (fracture-dislocation, severe joint impaction, severe trimalleolar)

Exclusion Criteria1

(i) Presence of vascular injury or pathologic fracture; (ii) Previous tibia pilon fracture or retained hardware in affected limb; (iii) Refusal to participate; (iv) Inability to obtain informed consent due to language barrier

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Interventions

PROCEDUREPrimary ankle arthrodesis (fusion)

Primary 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.

PROCEDUREORIF (open reduction and internal fixation)

ORIF: 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.

PROCEDUREIntramedullary Fibular Nailing (IMFN)

Intramedullary Fibular Nailing: Participants allocated to the IMFN group will receive a locked fibular nail using a previously described technique.