Primary Ankle Arthrodesis Versus Open Reduction and Internal Fixation for Fragility Fractures Around the Ankle in the Frail Elderly. — PILON  

Ankle Fractures Clinical Trial

Official title: PILON Study: Primary Ankle Arthrodesis Versus Open Reduction and Internal Fixation for Fragility Fractures Around the Ankle in the Frail Elderly: A Prospective, Randomized, Multi-Center, Clinical Trial

Status Recruiting

Clinical Trial 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

Clinical Trial Description

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 compare primary ankle arthrodesis to ORIF for the treatment of complex fractures around the ankle in the frail elderly. The primary research question is:

1) Does primary ankle fusion for the treatment of severe fractures around the ankle in the frail elderly result in improved outcomes and a lower rate of complications compared with ORIF?

Hypotheses:

The Investigators hypothesize that:

1. Primary fusion will result in improved health related quality of life, functional outcomes, pain and reduced complications compared to ORIF.

2. 2) Our null hypothesis is that primary fusion 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 multi-centre randomized clinical trial (RCT)

Setting: London Health Sciences Centre - Victoria Hospital, ON (coordinating centre); other participating centres thus far include:

St. Michael's Hospital, ON, Winnipeg Regional Hospital, Winnipeg, MN, Royal Columbian Hospital, New Westminster, BC.

Procedure: The local research team will screen admissions and clinic lists for eligible patients who will be characterized and 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 during the primary appointment with an orthopaedic surgeon, following appropriate radiographic scans, at which point an informed consent discussion will take place. The local research team will measure and capture outcomes during regularly scheduled clinic or hospital visits. ;

Related Conditions & MeSH terms

• Ankle Fractures
• Fractures, Bone
• Pilon Fracture

• NCT number: NCT05131321
• Study type: Observational
• Source: Lawson Health Research Institute
• Contact: Emil Schemitsch, MD, FRCS(C)
• Phone: 519-663-3307
• Email: emil.schemitsch@lhsc.on.ca
• Status: Recruiting
• Start date: April 21, 2022
• Completion date: December 2026