A Cohort Study of Bioabsorbable Screws for Syndesmosis Fixation
Research type
Research Study
Full title
A Cohort Study of Bioabsorbable Screws for Syndesmosis Fixation in Ankle Fracture
IRAS ID
209339
Contact name
Alan Johnstone
Contact email
Sponsor organisation
NHS Grampian
Duration of Study in the UK
1 years, months, days
Research summary
We 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 centers worldwide, and we therefore seek to evaluate syndesmosis fixation with them in our unit. We 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 we would use a limited CT scan (equivalent of about 3 months background radiation) after the time of fixation and at one year. We would also assess patient reported outcome measures and pain scores, length of procedure and intraoperative radiation levels.
REC name
North of Scotland Research Ethics Committee 1
REC reference
17/NS/0068
Date of REC Opinion
28 Jul 2017
REC opinion
Favourable Opinion