Comparing two surgical methods for treating ankle fractures in elderly patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to compare the effectiveness of primary ankle fusion versus open reduction and internal fixation (ORIF) for treating unstable ankle fractures in frail elderly patients. The study will involve randomizing participants to receive one of the two surgical interventions and will assess patient outcomes one year after the injury. Additionally, a second part of the trial will evaluate retrograde intramedullary fibular nailing against ORIF for less complicated unstable fractures. The goal is to determine which method provides better functional outcomes and lower complication rates in this vulnerable population.

Why it matters

Who can join: the full rules

Patient Inclusion Criteria - Both Parts:

(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

Part 1 Specific Inclusion Criteria:

(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)

Part 2 Specific Inclusion Criteria (i) Isolated fracture (within 4 weeks of injury): an AO/OTA type 44B2, B3, C1 or C2 ankle fracture

Patient Exclusion Criteria - Both Parts:

(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

Where it's running

• London Health Sciences Centre
  London, Ontario, Canada Recruiting

Study contacts

• Study coordinator: Emil Schemitsch, MD, FRCS(C)
• Email: emil.schemitsch@lhsc.on.ca
• Phone: 519-663-3307

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.