Weight-bearing Radiographs to Evaluate Stability in Ankles With Isolated Weber Type B Fractures.
Condition: Lateral Malleolus Fractures; Ankle Fractures
MeSH terms: Fractures, Bone; Ankle Fractures
Study type: Interventional

Summary: 
      The investigators will conduct a prospective cohort study on the use of weight-bearing
      radiographs to evaluate stability in ankles with isolated, trans-syndesmotic (Weber type B)
      fibular fractures. Stable fractures will be treated conservatively using a functional brace,
      unstable fractures will undergo surgical fixation.
    

Detailed description: 
      It is widely accepted that fractures in stable ankles can be treated non-operatively and
      fractures in unstable ankles needs internal fixation surgery (Michelson, Magid & McHale,
      2007, Gougoulias, Khanna, Seellariou, Maffulli, 2010). Clinical decision-making is thus based
      on ankle stability evaluation. The integrity of medial structures, mainly the deep deltoid
      ligament, is considered the most important determinant for stability of the ankle mortise
      (Michelson, Magid & McHale, 2007, Gougoulias, Khanna, Seellariou, Maffulli, 2010). Weber B
      fractures, with no obvious sign of medial side injury on initial plain radiographs, have to
      be considered of uncertain stability until adequate stress testing is performed.

      Currently there is no definite consensus on what test(s) best determines stability in ankles
      with undisplaced, isolated lateral malleolar fractures. Much used methods comprises manual
      stress radiographs and gravity stress radiographs (McConnel, Creevy & Tornetta, 2004).
      However recent studies have shown that such methods overestimate the need for surgical
      fixation indicating the need for a different method to make up the basis for surgical
      indication (Dawe, Shafafy, Quayle, Gougoulias, Wee & Sakellariou, 2015, Hastie, Akhtar, Butt,
      Baumann & Barrie, 2015, Holmes, Acker, Murphy, McKinney, Kadakia & Irwin, 2016, Hoshino,
      Nomoto, Norheim & Harris, 2012, Koval, Egol, Cheung, Goodwin & Spratt (2007), Seidel et al.,
      2017, Weber, Burmeister, Flueckiger & Krause, 2010). Authors of recent studies have proposed
      weightbearing radiographs as an alternative method to distinguish stable and unstable
      fractures, significantly reducing the need for operative treatment (Dawe et al., 2015, Hastie
      et al., 2015, Hoshino et al, 2012, Holmes et al., 2016, Seidel et al., 2017, Weber et al.
      2010).

      To evaluate weight-bearing radiographs ability to determine stability our primary focus is to
      evaluate if conservative treatment for "gravity unstable/weightbearing stable" ankles
      produces different outcomes than conservative treatment for "gravity stable/weightbearing
      stable" ankles.

      Participants will be assigned to non-operative or surgical treatment based on ankle stability
      evaluation using results from weightbearing radiographs consistently. Stable ankles will be
      treated non-operatively with a functional brace (AirCast) for 6 weeks. Participants will be
      instructed to bear weight as tolerated and to actively do standardized range-of-motion
      exercises. Standard operative treatment is open reduction and internal fixation of the
      fracture using plate and screws.
    

Intervention name(s): Open reduction internal fixation (ORIF); Conservative treatment
Intervention type(s): Procedure; Other
Intervention description(s): Open fracture reduction followed by internal fixation using a plate and screws. The goal is an osteosynthesis that allow for early range-of-motion exercises, but weightbearing is usually not tolerated until 6 weeks postoperatively.; Conservative treatment involves ankle protection with a functional brace (AirCast) for 6 weeks. Participants will be instructed to bear weight as tolerated and to actively do standardized range-of-motion exercises.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Two-arm parallel assignment. Based on stability evaluation using weight-bearing adiographs one group recieves surgery, one group recieves non-surgical treatment.
Masking: None (Open Label)
Primary purpose: Diagnostic