Volar Locking Plate vs Fragment Specific Fixation in Wrist Fractures
Condition: Distal Radius Fractures
MeSH terms: Fractures, Bone; Radius Fractures; Wrist Fractures
Study type: Interventional

Summary: 
      The treatment of unstable, non-reducible distal radial fractures is still controversial. The
      aim of the present study is to compare the subjective, clinical and radiographic outcome of
      the TriMed fragment-specific system with a volar locking plate in patients with unstable,
      non-reducible and also redislocated distal radial fractures.
    

Detailed description: 
      The distal radial fracture is one of the most common fractures, with an annual incidence in
      southern Sweden of 26 per 10,000 inhabitants (Brogren et al. 2007). Non-surgical treatment,
      predominantly plaster cast or simple splints, comprises the basic treatment in non-displaced
      fractures, as well as in displaced, but reducible fractures (Handoll and Madhok 2003). In the
      unstable, non-reducible distal radial fractures, surgical treatment is necessary but can be
      complex. The choice of method is still controversial (Chen and Jupiter 2007), especially
      regarding the result over time (Downing and Karantana 2008). External fixation has been the
      preferred method of operation for decades, but with the introduction of the volar locking
      plate technique, internal fixation has rapidly become more and more popular, without any
      solid foundation in the evidence-based medicine (Margaliot et al. 2005).

      We have shown in a randomized study that open reduction and internal fixation of distal
      radial fractures using the TriMed fragment-specific system resulted in better grip strength
      and forearm rotation at 1-year follow up than closed reduction and bridging external fixation
      (Abramo et al. 2009). Later we followed up the same cohort at a mean of 5-years, with the
      primary aim of determining whether the superior results of internal fixation in unstable
      distal radial fractures persist over time. The conclusion of this study was that, internal
      fixation is better than external fixation regarding grip strength and forearm rotation at
      1-year but the difference disappears at the 5-year follow-up as both groups approach normal
      values (Landgren et al. submitted in 2010).

      The aim of the present study is to compare the subjective, clinical and radiographic outcome
      of the TriMed fragment-specific system with a volar locking plate in patients with unstable,
      non-reducible and also redislocated distal radial fractures. The patients who meet all
      eligibility criteria and provide consent to participate will be randomly assigned to
      reduction and fixation with either volar locking plate or Trimed fragment-specific system.
      Patients will undergo physiotherapy, clinical evaluation, radiographic evaluation at fixed
      intervals and will also include QuickDASH, VAS, SF-12 and EQ5D. There will be 25 patients in
      each arm and the patients will be followed for 12 months.
    

Intervention name(s): Open reduction and fixation with TriMed fragment-specific system; Open reduction and fixation with TriMed volar locking plate
Intervention type(s): Procedure; Procedure
Intervention description(s): Anatomical reduction, achieved by the open technique.; Anatomical reduction, achieved by the open technique.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Fracture; Radius; Surgery; Osteosynthesis