Ankle Syndesmosis Fixation by Antibiotic Releasing Bioabsorbable Screw
Condition: Ankle Fracture
MeSH terms: Fractures, Bone; Ankle Fractures
Study type: Interventional
Phase: Phase 2

Summary: 
      This single-center randomized trial evaluates the efficacy and safety of a new bone screw
      (antibiotic releasing bioabsorbable screw) in fixation of syndesmosis in patients with Weber
      C-type ankle fractures. The comparison is made to subjects treated by conventional metal
      screw fixation of the syndesmosis. The primary objective is to show that the antibiotic
      releasing bioabsorbable screw is at least as good as the routinely used metal screw in
      prevention of syndesmosis widening in patients with Weber C-type ankle fractures. The
      secondary objective is to show that the clinical outcome of the ankle fracture treatment is
      equal between patients treated by the antibiotic releasing bioabsorbable screw and the
      conventional metal screw.
    

Detailed description: 
      This is a randomized parallel-group single centre study. All the patients enrolled will have
      an acute, closed Weber C-type ankle fracture. The ankle syndesmosis will be fixed using the
      new medical device (antibiotic containing bioabsorbable screw) or the routinely used device
      (metal screw). The investigational antibiotic containing bioabsorbable screw for ankle
      syndesmosis repair (the thread diameter 4.5 mm) will be made of bioabsorbable
      poly(lactide-co-glycolide) (PLGA) 80:20 and ciprofloxacin, which is a bactericidal
      antibiotic. The main purpose of the screw is to prevent syndesmosis widening after Weber
      C-type of ankle fracture. The secondary function of the screw is to reduce the risk for
      colonization of the implant with bacteria and subsequently prevent biomaterial-related
      infection. In the control group, a stainless steel screw will be used. All patients will
      receive the standard of care for concomitant fractures and other injuries of the ankle.

      The key variables in the assessment will be radiostereometric (RSA) measurements of the
      syndesmosis width, CT imaging of the ankle mortise and standard radiographic evaluation of
      the syndesmosis width and ankle mortise. Clinical outcome of the ankle fracture treatment
      will be measured using standardized outcome questionnaires (RAND-36, AAOS Foot and Ankle
      Outcome Instrument, Olerud and Molander score, VAS pain scale). The follow-up of the patients
      will be 52 weeks. The metal screw will be removed 8 weeks after fracture surgery. The
      expected mechanical integrity of the bioabsorbable screw is 6 - 8 weeks, while the complete
      absorption time of the bioabsorbable screw in human body is expected to be approximately two
      years
    

Intervention name(s): A ciprofloxacin containing bioabsorbable PLGA bone screw
Intervention type(s): Procedure
Intervention description(s): The syndesmosis injury will be fixed the antibiotic releasing bioabsorbable bone screw or a standard metal screw. After surgery, the ankle will be immobilized in a cast for 6 weeks. The metal screw will be surgically removed at 8 weeks. The bioabsorbable screw will be left in place.
Other intervention name(s): Manufactured in Tampere University of Technology/Bioretec Ltd
Intervention MeSH terms: Ciprofloxacin
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: bioabsorbable implant; bone screw; local antibiotic prophylaxis; syndesmosis injury; ankle fracture; ciprofloxacin