skip to Main Content

A Prospective Randomized Multicenter Trial Comparing Clinical Outcomes of Patients Treated Surgically with a Static or Dynamic Implant for Acute Ankle Syndesmosis Rupture (JOT 2015)

Screenshot-2015-05-19-23.52.58-73x98 A Prospective Randomized Multicenter Trial Comparing Clinical Outcomes of Patients Treated Surgically with a Static or Dynamic Implant for Acute Ankle Syndesmosis Rupture (JOT 2015) Journal Club Trauma | JC


Study hypothesis

Dynamic fixation would provide better clinical and radiographic outcomes

Design

  • 70 pts total between 5 centers (ended with 32 in screw and 33 in tightrope)
    • no differences b/w pts
  • surgery < 8 days after injury
  • prospective, randomized, double blinded study
  • exclusion criteria: polytrauma, neuro impairment, BMI >40, poor medical condition that limited rehab or participation in study’s tests
  • ORIF of malleoli fx’s at same time, no open reduction of syndesmosis
  • Standardized post op protocol
    • NWB x 6 wks in splint then cast, progressive WBAT w/o formal PT
  • Outcome Measures
    • Olerud-Molander (OM) score, AOFAS, VAS pain scale, active ROM, swelling, time to return to work, XR’s (lateral TF clear space (nl <6mm) and medial clear space)
    • All at 3,6, and 12mo after surgery

Results

  • 2 pts with tightrope had infection requiring removal
  • 1 pt with screw required revision surgery for poor initial fixation, 11 required screw removal for pain
  • tightrope group near statistically better on OM score at all f/u’s, AOFAS only stat better at 3mo, plantarflexion only stat better at 3mo
  • no statistical difference in dorsiflexion, edema, or return to work or sports
  • adequate radiographic reduction in all but 1 screw pt with early revision surgery
  • no correlation b/w loss of reduction and clinical outcomes
  • screw broke in 13 pts w/o loss of reduction, no tightrope failure, no ORIF failure

Discussion

  • Strengths
    • Prospective, randomized, double blinded with pts and evaluators, large # of patients, similar post op protocol, general orthopaedists, good outcome measures
  • Weaknesses
    • Only 1yr f/u – no long term assessment for arthritis/tightrope failure/etc., study grant from Arthrex so may have bias, reduction verified by XR only – could use CT for better assessment, did not list their criteria for syndesmosis instability
Back To Top