title: A prospective randomized multicenter trial comparing clinical outcomes of patients treated surgically with a static or dynamic implant for acute ankle syndesmosis rupture.
abstract: OBJECTIVE
  To compare the clinical and radiographic outcome after stabilization of an acute syndesmosis rupture with either a static implant (a 3.5-mm metallic screw through 4 cortices) or a dynamic device (TightRope; Arthrex).
  
  
  METHODS
  Multicenter randomized double-blind controlled trial.
  
  
  METHODS
  Study realized in 5 trauma centers (2 level 1 and 3 level 2) in 2 countries.
  
  
  METHODS
  Seventy subjects admitted for an acute ankle syndesmosis rupture entered the study and were randomized into 2 groups (dynamic fixation = 34 and static fixation = 36). The 2 groups were similar regarding demographic, social, and surgical data. Sixty-five patients (dynamic = 33 and static = 32) completed the study and were available for analysis.
  
  
  METHODS
  Syndesmosis fixation in the static group was realized with a 4 cortices 3.5-mm cortical screw (Synthes) and in the dynamic group with 1 TightRope (Arthrex). Standardized rehabilitation process for the 2 groups: no weight bearing in a cast for 6 weeks and then rehabilitation without protection.
  
  
  METHODS
  Olerud-Molander score.
  
  
  RESULTS
  Subjects with dynamic fixation achieved better clinical performances as described with the Olerud-Molander scores at 3 (68.8 vs. 60.2, P = 0.067), 6 (84.2 vs. 76.8, P = 0.082), and 12 months (93.3 vs. 87.6, P = 0.046). We also observed higher American Orthopaedic Foot and Ankle Society scores at 3 months (78.6 vs. 70.6, P = 0.016), but these were not significant at 6 (87.1 vs. 83.8, P = 0.26) or 12 months (93.1 vs. 89.9, P = 0.26). Implant failure was higher in the screw group (36.1% vs. 0%, P < 0.05). Loss of reduction was observed in 4 cases in the static screw group (11.1% vs. 0%, P = 0.06).
  
  
  CONCLUSIONS
  Dynamic fixation of acute ankle syndesmosis rupture with a dynamic device seems to result in better clinical and radiographic outcomes. The implant offers adequate syndesmotic stabilization without failure or loss of reduction, and the reoperation rate is significantly lower than with conventional screw fixation.
  
  
  METHODS
  Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.
authors.affiliation: *Department of Orthopaedic Surgery, CHU de Québec, Centre Hospitalier de l'Université Laval (CHUL), Québec, Québec, Canada; †Department of Orthopaedic Surgery, CHU de Québec, L'Hôtel-Dieu de Québec, Québec, Québec, Canada; ‡Department of Orthopaedic Surgery, CHU de Québec, Hôpital Enfant-Jésus, Québec, Québec, Canada; §Department of Orthopaedic Surgery, OLVG, Amsterdam, the Netherlands; ‖Department of Orthopedic Surgery, Dalhousie University, Halifax, Nova Scotia, Canada; and ¶Centre de recherche FRSQ du CHAUQ de Québec, Hôpital Enfant-Jésus, Québec, Québec, Canada.
authors.forename: Mélissa
authors.initials: M
authors.lastname: Laflamme
authors.forename: Etienne L
authors.initials: EL
authors.lastname: Belzile
authors.forename: Luc
authors.initials: L
authors.lastname: Bédard
authors.forename: Michel P J
authors.initials: MP
authors.lastname: van den Bekerom
authors.forename: Mark
authors.initials: M
authors.lastname: Glazebrook
authors.forename: Stéphane
authors.initials: S
authors.lastname: Pelet
mesh_terms: D000328:Adult; D016512:Ankle Injuries / Q000000981:diagnostic imaging / Q000601:surgery*; D000843:Ankle Joint / Q000000981:diagnostic imaging / Q000601:surgery*; D001863:Bone Screws; D004311:Double-Blind Method; D005260:Female; D005593:Fracture Fixation, Internal / Q000295:instrumentation*; D006801:Humans; D007593:Joint Instability / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011859:Radiography; D012086:Reoperation; D053441:Suture Anchors; D013536:Suture Techniques; D013537:Sutures; D016896:Treatment Outcome