We assessed syndesmotic set screw strength and fixation capacity during cyclical testing in a cadaver model simulating protected weight bearing. Sixteen fresh frozen legs with artificial syndesmotic injuries and a syndesmotic set screw made of stainless steel or titanium, inserted through three or four cortices, were axially loaded with 800 N for 225,000 cycles in a materials testing machine. The 225,000 cycles equals the number of paces taken by a person walking in a below knee plaster during 9 weeks.
Syndesmotic fixation failure was defined as: bone fracture, screw fatigue failure, screw pullout, and/or excessive syndesmotic widening.
None of the 14 out of 16 successfully tested legs or screws failed. No difference was found in fixation of the syndesmosis when stainless steel screws were compared to titanium screws through three or four cortices. Mean lateral displacement found after testing was 1.05 mm (S.D. = 0.42). This increase in tibiofibular width exceeds values described in literature for the intact syndesmosis loaded with body weight. Based on this laboratory study it is concluded that the syndesmotic set screw cannot prevent excessive syndesmotic widening when loaded with a load comparable with body weight. Therefore, we advise that patients with a syndesmotic set screw in situ should not bear weight.