Abstract
Flexible fixation techniques combined with anatomic (open) syndesmosis reduction have demonstrated improved functional outcomes and rates of malreduction. Suture-button devices allow physiologic motion of the syndesmosis without need for implant removal, which may lower the risk of recurrent syndesmotic diastasis. There is limited longer-term assessment of the maintenance of reduction between static and flexible syndesmotic fixation using bilateral ankle CT evaluation.
This is an a priori planned subgroup analysis of a multi-centre, randomized clinical trial comparing static syndesmosis fixation (two 3.5 mm screws) with flexible fixation (single knotless Tightrope) for patients with AO- OTA 44-C injuries. Patients who completed bilateral ankle CT scans at 3- and 12-month follow-up were included. The primary outcome measure was syndesmotic malreduction based on bilateral ankle CT scans, using the uninjured, contralateral ankle as a control. Anterior (ASD), middle (MSD), and posterior (PSD) syndesmosis distance were calculated to measure syndesmosis reduction. Secondary outcomes included re-operation, adverse events and functional outcomes including the EQ5D, Olerud-Molander Ankle Score (OM), Foot and Ankle Disability Index (FADI), and Work Productivity Activity Impairment Questionnaire (WPAI). Paired samples t-tests were used to compare injured to control ankles (R, v 3.5.1).
42 patients (24 Group S, 18 Group T) were included. ASD for Group T was 5.22mm (95%CI 4.69–5.77) at 3 months compared to 4.26mm (95%CI 3.82–4.71; p=0.007) in controls and 5.38mm (95%CI 4.72–6.04) at 12 months compared to 4.44mm (95%CI 3.73–5.16; p=0.048) in controls. ASD for Group S was 4.63mm (95%CI 4.17– 5.10) at 3 months compared to 4.67mm (95%CI 4.24–5.10; p=0.61) in controls, but significantly increased to 5.73mm (95%CI 4.81–6.66) at 12 months compared to 4.65mm (95%CI 4.15–5.15; p=0.04) in controls. MSD results were similar; Group T had a larger MSD than control ankles at 3 months (p=0.03) and 12 months (p=0.01), while the MSD in Group S was not different at 3 months (p=0.80) but increased at 12 months (p=<0.01). 88% (21/24) of Group S had broken or removed screws by 12 months. Unplanned re-operation was 15% in Group S and 4% in Group T (p=0.02), with an overall re-operation rate of 30% in Group S. There was no significant difference between treatment groups for EQ-5D, OM, FADI or WPAI at 3- or 12-month follow-up.
Tightrope fixation resulted in greater diastasis of the ASD and MSD compared to contralateral, uninjured ankles at 3- and 12-months post-fixation. Group S initially had syndesmotic reduction similar to control ankles, but between 3- and 12-months post-fixation, there was significantly increased syndesmosis diastasis compared to controls. The majority of Group S (88%) had either broken screws or scheduled screw removal, which may explain the increased tibio-fibular diastasis seen at 12-months.
