Volar Internal Plate Fixation vs. Plaster in Extra- Articular Distal Radial Fractures
Condition: Displaced Extra-articular Distal Radius Fractures
MeSH terms: Fractures, Bone; Radius Fractures; Wrist Fractures
Study type: Interventional

Summary: 
      BACKGROUND:

      Fractures of the distal radius are common and account for an estimated 17% of all fractures
      diagnosed. Two-thirds of these fractures are displaced and require reduction. Although distal
      radius fractures are considered to be relatively harmless, inadequate treatment may result in
      impaired function of the wrist. The consequences of post-traumatic loss of function are
      comprehensive, both on an individual and a social level, and have long been underestimated.
      Despite the substantial implications, no evidence-based treatment method yet exists. Good
      results have been described both in patients treated conservatively and surgically.
      Nevertheless, 60% of all fractures redislocate after conservative treatment at which point
      surgical reduction and fixation is the treatment of choice. Recently, the use of volar
      locking plates has become more popular. This type of osteosynthesis employs a volar approach
      to the wrist and provides immediate stable fixation of the reduced fracture. This stability
      allows for early mobilisation and may therefore result in an improved regain of function. The
      aim of this study is to compare the functional outcome following surgical reduction and
      fixation with a volar locking plate with the functional outcome following closed reduction
      and plaster immobilisation at one year follow-up in patients with displaced extra-articular
      distal radius fractures.

      DESIGN:

      This single blinded randomised controlled trial will randomise between open reduction and
      internal fixation with a volar locking plate (intervention group) and closed reduction
      followed by plaster immobilisation (control group). The study population will consist of all
      consecutive adult patients who are diagnosed with a displaced extra-articular distal radius
      fracture which has been adequately reduced at the Emergency Department. The primary outcome
      (functional outcome) will be assessed by means of the Disability Arm Shoulder Hand Score
      (DASH). Since the treatment allocated involves a surgical procedure, randomisation status
      will not be blinded. However, the researcher assessing the outcome at one year will be
      unaware of the treatment allocation. In total, 90 patients will be included in this trial
      which will be conducted in the Academic Medical Centre Amsterdam and its partners of the
      regional trauma care network.
    


Intervention name(s): open reduction and internal fixation; Closed reduction and plaster
Intervention type(s): Procedure; Other
Intervention description(s): The surgery will be performed by a certified trauma surgeon. After the fracture site is exposed, the fracture will be reduced and provisionally fixed with K-Wires and reduction forceps. An appropriate volar locking plate which best suits the anatomy of the wrist and the fracture type will be selected. Screw placement and fracture reduction will be confirmed intra-operatively by radiographic images. No post-operative fixation will be applied and patients will be instructed to use the affected extremity in daily activities as pain allows. According to Dutch treatment standards, vitamin C 500 milligrams will be prescribed to all patients at initial presentation and for a duration of two months in order to prevent Complex Regional Pain Syndrome.; Closed reduction will be performed according to the Robert-Jones method. This involves increasing the deformity first, then applying continuous traction and immobilising wrist and hand in the reduced position. Additional radiographs will be performed to verify the quality of the reduction. After this has been confirmed, the wrist will be immobilised according to Dutch guidelines: a splint for one week followed by a circular cast for another four weeks. According to Dutch treatment standards, vitamin C 500 milligrams will be prescribed to all patients at initial presentation and for a duration of two months in order to prevent Complex Regional Pain Syndrome.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: distal radius fractures; Closed reduction; Open reduction internal fixation; Volar plate; Redislocation; Unstable fracture; Extra-articular fracture; Colles fracture; Barton fracture