Image

The Benefit of Repairing the Deltoid Ligament in Unstable Ankle Fractures

The Benefit of Repairing the Deltoid Ligament in Unstable Ankle Fractures

Recruiting
18-65 years
All
Phase N/A

Powered by AI

Overview

Ankle fractures occur in 1 out of 800 persons a year and is a common injury. The deltoid ligament is necessary for the stability of the joint and guides choice of treatment. Cadaveric studies have shown that deltoid ligament repair gives more stability than the osteosynthesis of the lateral malleolus itself. The investigators want to show if suture of the deltoid ligament in unstable ankle fractures contribute to a better functional result and/or prevent long term osteoarthritis for our participants. Patients sustaining severe ankle fractures have shown a considerable loss of function that might affect their long term activities of daily living (ADL) function. Improving outcome for this group may preserve some patients' ability to work and reduce community expenses.

Description

During the last two decades less severe ankle fractures have been shown not to need operative treatment in general. The total number of ankle fracture surgeries has gone down. Therefore, surgically treated ankle fractures nowadays are on average more complex. The understanding of these injuries implies a recognition of the role of the deep deltoid ligament as a main stabilizer of the ankle joint. Deltoid ligament repair is documented to be a good option to regain ankle joint anatomy from smaller studies. This repair also compensates for syndesmotic injury to some extent. The effect of deep deltoid ligament repair in Weber B ankle fractures and its effect on long term function and arthritis is not yet known from clinical studies.

The investigators aim to show whether deltoid ligament suture gives a clinically significant superior result than solely osteosynthesis of the lateral malleolus in unstable ankle fractures. This will be performed as a multicentre randomized controlled study.

Eligibility

Inclusion criteria; fluent in oral and written Norwegian language

  • isolated Weber type B fractures and Weber B+ posterior malleolar Mason Molloy class I.
  • Initial medial clear space (MCS)>=7mm or weightbearing x-ray evaluated as unstable or primary reposition after fracture dislocation.
  • Pre-injury walking ability without aids.

Exclusion criteria

  • assumed not compliant (drug use, cognitive- and/or psychiatric disorders).
  • previous history of ipsilateral ankle fracture or ipsilateral major ankle-/foot surgery.
  • open fx Gustilo Anderson II or more, multi-trauma and pathologic fracture.
  • neuropathies and generalized joint disease such as Rheumatoid Arthritis or other more severe condition in same extremity
  • fixation of tibial fragment or syndesmotic screw or suture button planned prior to surgery

Study details
    Ankle Fractures
    Deltoid Ligament; Sprain (Strain) (Ankle)

NCT06568276

Ostfold Hospital Trust

15 October 2025

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.