Above-versus Below-elbow Casting for Conservative Treatment of Distal Radius Fractures
Condition: Distal Radius Fracture
MeSH terms: Fractures, Bone; Radius Fractures; Wrist Fractures
Study type: Interventional

Summary: 
      For the non-surgical treatment of distal radius fractures in adults a variety cast options
      are available, including or not the elbow joint. The literature is inconclusive regarding the
      need to immobilize the elbow joint after reduction of the distal radius fracture.This study
      was undertaken to evaluate the best method of immobilization between the above and
      below-elbow cast groups at the end of 6 months of follow-up.
    

Detailed description: 
      To determine the best method of immobilization ( below elbow versus above elbow splint) in
      patients with distal radius fractures at the end of 6 months of follow-up:

        -  Type of study: Prospective, randomized and controlled trial.

        -  Patient recruitment: Adults attended in emergency room with closed acute displaced
           distal radius fracture will be reduced under general venous anesthesia with fluoroscopic
           control.

      Displaced and reducible fractures (after venous anesthesia) will be included if one of these
      conditions is present: Radial height - loss > 2 mm , radial Inclination- loss > 4°, dorsal
      tilt - > 10°, ulnar variance - loss > 3 mm, intra-articular step off or gap - > 2mm . The
      contralateral side will be used as a reference.

      The eligible participants will be informed about the nature and purpose of the study by
      reading the "Informed Consent Term" after ageeement, patients will included in the trial and
      randomized.

        -  Maintenace of reduction will be defined as the maintenance of the parameters listed
           above.

        -  Patients with above elbow immobilization will remain for 4 weeks with splint followed by
           2 weeks of below elbow immobilization. The immobilization will be removed with 6 weeks.

        -  The primary outcome is: maintenance of reduction by evaluation of radiographic
           parameters (wrist radiographs) at one, two, three, four, six, eight, twelve and twenty
           four weeks after fracture reduction and self-reported function assessment Disabilities
           of the Arm, Shoulder and Hand questionnaire(DASH).

        -  Secondary outcomes:Patient Rated Wrist Evaluation- PRWE. Pain (VAS - "Visual Analogue
           Pain Scale"). Objective functional evaluation (goniometry and dynamometry) and rate of
           complications and failures.

        -  Sample Size calculation was calculated based on data derived from one recent randomized
           clinical trial on the subject. We considered as relevant differences on DASH scores
           (clinically relevant) when scores are greater than 10 points and standard deviation 15
           points. To detect this difference (Student T-test) and statistical power of 95% resulted
           in a 58 patient sample size per group. We considered an extra 10% for balancing follow
           up losses. Thus, our inclusion target will be 64 patients per group. We considered the
           test as bicaudal.

      Benefits: Below elbow splinting is easier to apply, lower cost, more comfortable and permits
      better function for daily life activity.
    

Intervention name(s): Below elbow immobilization; Above elbow immobilization
Intervention type(s): Device; Device
Intervention description(s): 20cm wide gypsum in the forearm cut to fit the thumb.; 20cm wide gypsum in the forearm cut to fit the thumb associated a elbow splint made with a 15cm width on the ulnar aspect of the forearm that begins at the middle of the forearm and extends into the armpit.
Other intervention name(s): Plaster immobilization with elbow free (Below elbow); Plater immobilization including elbow (Above elbow)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: conservative treatment, treatment outcome