This section describes efficacy outcomes from the published literature that the Committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the interventional procedure overview.
4.1 A randomised controlled trial of 70 patients with acute ankle syndesmosis rupture compared suture fixation (n=34) against screw fixation (n=36). Sixty‑five patients completed the study (suture fixation, n=33; screw fixation, n=32) and were included in the analysis. The study reported that patients with suture fixation had significantly better functional scores than those in the screw fixation group (measured with the Olerud and Molander Ankle Score) at 12 months (93.3 versus 87.6, p=0.046), but the difference was not significant at 3 months (68.8 versus 60.2, p=0.067) or at 6 months (84.2 versus 76.9, p=0.082). Statistically significantly better American Orthopaedic Foot and Ankle Society (AOFAS) scores were seen at 3 months in the suture fixation group compared with the screw fixation group (78.6 versus 70.6, p=0.016), but these were not significant at 6 months (87.1 versus 83.8, p=0.260) or at 12 months (93.1 vs 89.9, p=0.260). A retrospective case series of 49 patients with ankle diastasis treated with suture fixation (a slightly modified technique was used in 31 patients) reported that the mean AOFAS score was 85.57 and the mean Foot and Ankle Disability Index score was 81.20 at a 24‑month average follow‑up.
4.2 A non‑randomised comparative study of 50 patients with distal tibiofibular diastasis comparing suture fixation (n=25) against screw fixation (n=25) reported no significant difference in the average time to full weight bearing between the suture fixation group and the screw fixation group at an average follow‑up of 10.8 months and 8.2 months respectively (mean time 5.5 weeks versus 10.5 weeks, but the difference was not significant).
4.3 The randomised controlled trial of 70 patients reported that there were no significant differences in return to previous work or sporting activities between the suture fixation and screw fixation groups at 12‑month follow‑up (return to work, 97% versus 88%, p=0.19; return to sporting activities, 79% versus 69%, p=0.41).
4.4 The randomised controlled trial of 70 patients reported that adequate syndesmosis reduction was achieved in both groups. Patients in the screw fixation group had a statistically significantly higher mean radiological 'loss of reduction' compared with those in the suture fixation group (medial clear space 0.41 mm versus 0.05 mm, p=0.02; lateral tibiofibular clear space 1.34 mm versus 0.32 mm, p=0.0005).
4.5 The randomised controlled trial of 70 patients reported no significant difference in the range of ankle motion (dorsal and plantar flexion, and ankle circumference) or in ankle pain (Visual Analogue Scale for pain) between the screw and suture fixation groups at 6‑ and 12‑month follow‑up.
4.6 A retrospective comparative case series of 35 patients (12 in the suture fixation group and 23 in the screw fixation group) reported that no patients in the suture fixation group had recurrent diastasis at discharge, while 1 patient in the screw fixation group had syndesmotic diastasis.
4.7 The specialist advisers listed key efficacy outcomes as maintaining ankle stability and anatomic reduction of the tibiofibular syndesmosis, and assessment of ankle pain, function and range of movement using common foot and ankle scoring systems (the AOFAS score, the Olerud and Molander Ankle Score and the Manchester–Oxford Foot Questionnaire).