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

  • End date
    Dec 19, 2026
  • participants needed
  • sponsor
    Lawson Health Research Institute
Updated on 7 October 2022
internal fixation
open reduction


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


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


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?

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


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.

Condition Ankle Fractures, Pilon Fracture
Treatment Primary ankle arthrodesis (fusion), ORIF (open reduction and internal fixation)
Clinical Study IdentifierNCT05131321
SponsorLawson Health Research Institute
Last Modified on7 October 2022


How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact


Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note