Retrograde Nailing Versus Open Reduction and Internal Fixation for Unstable Fractures Around the Ankle in the Frail Elderly

Launched by LONDON HEALTH SCIENCES CENTRE RESEARCH INSTITUTE OR LAWSON RESEARCH INSTITUTE OF ST. JOSEPH'S · Nov 10, 2021

Keywords

ClinConnect Summary

This clinical trial is looking at two different ways to treat unstable ankle fractures in elderly patients. Specifically, it compares a surgical procedure called open reduction and internal fixation (ORIF) with a technique known as retrograde intramedullary fibular nailing. The goal is to see which treatment leads to better recovery outcomes for patients one year after their injury. The trial is being conducted at multiple sites, with the London Health Sciences Centre as the lead location, and is currently recruiting participants.

To participate, you need to be at least 60 years old and have certain health conditions or types of ankle fractures that make you eligible. This includes having severe injuries or health issues like diabetes or frailty. If you join the trial, you'll be randomly assigned to one of the two treatment groups and will be asked to follow up after one year to see how well the treatment worked for you. It's important to note that not everyone can participate; for example, if you have a history of certain injuries or can't provide consent due to language barriers, you won't be eligible. This study aims to improve how ankle fractures are treated in older adults, helping them recover more effectively.

Gender

ALL

Eligibility criteria

• 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 ≥5 \[13\]
• 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