Ask to take part

Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Mariam Sattar, MBChB(Hons) 00441224552310
mariam.sattar@nhs.scot


Alan Johnstone, MBChB FRCS Alan.johnstone2@nhs.scot


Study Location:

Skip to Main Content
English | Cymraeg
Be Part of Research - Trial Details - A Cohort Study of Bioabsorbable Screws for Syndesmosis Fixation Fixation in Ankle Fracture

A Cohort Study of Bioabsorbable Screws for Syndesmosis Fixation Fixation in Ankle Fracture

Recruiting

Open to: ALL

Age: 18.0 - 65.0

Medical Conditions

Wounds and Injuries
Fractures, Bone
Ankle Fractures
Ankle Injuries


This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


The investigators aim to evaluate the fixation of the ankle syndesmosis in appropriate ankle fractures with bioabsorbable screws.

Ankle fractures are common, and a proportion of them involve both fracture of the bone and also disruption of the syndesmosis, a strong ligamentous complex connecting the distal fibula and tibia. If left without fixation this causes a high incidence of pain and early arthritis. The most common technique for fixation of this syndesmosis involves the use of the same type of metal screws used to fix the fractured bones. As the syndesmosis permits small degrees of movement in normal subjects, fixation of this with metal usually leads to screw breakage and, or pain. It is common practice to remove these screws after a period of time once the syndesmosis has healed in the correct position.

Bioabsorbable screws have the advantage of allowing small increments of movement, and also resorb naturally therefore do not have to be removed with a second surgical procedure. They are used in other centres worldwide, and the investigators therefore seek to evaluate syndesmosis fixation with them in their unit. The investigators would aim to recruit patients who have a syndesmotic injury requiring fixation, and who can consent to participating. They would undergo an identical surgical procedure to the standard current practice, apart from using a bioabsorbable screw in exchange for the metallic screw for syndesmosis fixation. All other components would remain unchanged, as would post operative protocol and management. To evaluate the fixation the investigators would use a limited CT scan (equivalent of about 3 months background radiation) after the time of fixation and at one year. This will help to assess the maintenance of reduction of the syndesmosis with time. The investigators would also assess patient reported outcome measures and pain scores, length of procedure and intraoperative radiation levels, weight bearing distribution tests, as well as any complication that may arise.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Apr 2021 Dec 2024

Publications

"Phisitkul P, Ebinger T, Goetz J, Vaseenon T, Marsh JL. Forceps reduction of the syndesmosis in rotational ankle fractures: a cadaveric study. J Bone Joint Surg Am. 2012 Dec 19;94(24):2256-61. doi: 10.2106/JBJS.K.01726."; "23318616"

OBSERVATIONAL

Intervention Type : DEVICE
Intervention Description : as described prior

Intervention Arm Group : Ankle fracture with syndesmosis injury;



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Aberdeen Royal Infirmary
    Aberdeen
    AB25 2ZN

Alan Johnstone, MBChB FRCS Alan.johnstone2@nhs.scot


Mariam Sattar, MBChB(Hons) 00441224552310
mariam.sattar@nhs.scot



The study is sponsored by NHS Grampian




We'd like your feedback

Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.


Is this study information helpful?

What will you do next?

Read full details for Trial ID: NCT05662449
Last updated 14 December 2022

This page is to help you find out about a research study and if you may be able to take part

You can print or share the study information with your GP/healthcare provider or contact the research team directly.