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Which surgery is best for frail seniors with broken ankles? new study aims to find out

NCT ID NCT05131321

Disease control Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares two types of surgery for unstable ankle fractures in frail adults aged 60 and older. One group gets ankle fusion (joining the bones together), and the other gets open reduction and internal fixation (using plates and screws to hold the bones in place). A second part of the study also compares a less invasive nailing technique to standard fixation. The goal is to see which approach leads to better quality of life and less pain one year after surgery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
surgery (ankle fusion or open reduction and internal fixation)
What this could lead to
If this trial succeeds, it could identify the best surgical approach for frail elderly patients with ankle fractures, improving their recovery and quality of life.
What could go wrong
This is a relatively small trial (172 participants) comparing two established procedures, so it may not find a clear winner. Results may not apply to all patients or settings.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 172 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2022

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Ankle fracture patients receiving care at the participating institutions will be eligible for enrolment based on the eligibility criteria.

Ages

40 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Ankle Fractures tibia fracture

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Ankle fractures Pilon fracture

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • London Health Sciences Centre

    RECRUITING

    London, Ontario, N6A5W9, Canada

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