5 Safety

5 Safety

This section describes safety 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.

5.1 Device removal was reported in: 25% (6/24) of patients in a retrospective case series of 24 patients at a mean follow‑up of 20 months; 17% (3/18) of patients treated with a standard suture technique in a case series of 49 patients at a mean follow‑up of 24 months; 8% (8/102) of patients in a retrospective case series of 102 patients at a median follow‑up of 85 days; 17% (2/12) of patients in the suture fixation group in a retrospective comparative case series of 35 patients at a mean follow‑up of 12.4 weeks; and 11% (4/37) of patients in a retrospective case series of 37 patients at a mean follow‑up of 23.6 months. The reported reasons for device removal in these studies included: prominent knot causing local skin irritation a few months after surgery (n=10); persistent pain with activity and restriction of motion in the ankle (n=1); deep wound infection or infectious sinus formation on the lateral side (n=2); osteomyelitis surrounding the device (n=3); radiological track widening (caused by painful aseptic osteolysis, n=2); failed stabilisation of the syndesmosis (n=2); unexplained pain (n=1); small stitch abscess in the medial ankle wound (n=1); peroneal nerve injury with neuropraxia (n=1); and osteochondral defect (n=1).

5.2 Subsidence of the suture buttons into the bone (caused by osteolysis of the bone adjacent to the buttons) was reported in 17% (4/24) of patients in the case series of 24 patients. The suture buttons subsided 2–4 mm into the cortex of either the fibula or tibia, seen on final radiographs at 32‑month mean follow‑up.

5.3 Non‑fatal pulmonary emboli and symptomatic deep vein thrombosis were each reported in 2% (2/102) of patients in the case series of 102 patients at a median follow‑up of 85 days (further details were not reported).

5.4 Tibialis anterior tendon entrapment from the medial suture button in close proximity to the peroneal nerve was reported in the immediate postoperative period after double‑suture fixation in a case report of 1 patient with re‑fracture of a Weber B, bimalleolar ankle fracture and distal tibiofibular diastasis. The suture and a screw were removed and a second suture was inserted through the plate. Paraesthesia resolved completely and the patient returned to pre‑fracture mobility after 6 weeks.

5.5 Heterotopic ossification within the syndesmosis intraosseous ligaments adjacent to the sutures (seen on computed tomography) was reported in 13% (3/24) of patients in the case series of 24 patients.

5.6 Distal tibiofibular synostosis after suture fixation of an ankle fracture with syndesmotic instability was reported in a case report of 1 patient. Six weeks after surgery, radiographs showed some signs of callus formation between the tibia and the fibular, but synostosis and anterior ankle pain occurred at 1‑year follow‑up (management details were not reported).

5.7 Enlargement of suture drill holes in the tibia and fibula were reported in some patients in the case series of 24 patients. Further details were not reported.

5.8 Acute fracture of the tibia and fibula through the suture button fixation tunnel, previously done for syndesmotic disruption, was reported in a case report of 1 patient. The suture device was removed without difficulty and open reduction and internal fixation of the fracture were done. At 12‑month follow‑up, the patient returned to high‑intensity sport activity and radiographs revealed a well‑healed tibia and fibula.

5.9 In addition to safety outcomes reported in the literature, specialist advisers are asked about anecdotal adverse events (events which they have heard about) and about theoretical adverse events (events which they think might possibly occur, even if they have never done so). For this procedure, specialist advisers listed the following anecdotal adverse events: difficulty with tightening the device sufficiently, and malreduction or failure of the fixation because of soft tissue interposition (medial button). They considered that the following were theoretical adverse events: loss of fixation or stability of the syndesmosis (rediastasis), especially in older people who have osteopenia or osteoporosis, malreduction of the syndesmosis before fixation, and suture failure.

  • National Institute for Health and Care Excellence (NICE)