Treatment of unstable distal radius fractures with volar plates or external fixation: a randomized prospective study

Abstract

Distal radius fractures are frequent found upper limb injuries. Besides its high occurrence, there is no clear evidence regarding on which is the best surgical treatment option. Aim: We aim to perform a randomized prospective study to compare two treatment options for treating unstable distal radius fractures: external fixation or volar platting, considering self-reported functional scale as primary outcomes. Methods: Patients will be enrolled in a randomized method by sealed envelopes. Patients with acute distal radius fractures (less than 15 days). We will include AO-ASIF types A2, A3, C1, C2, C3. All surgeries will be operated in an outpatient hand clinic. A minimum twelve-month follow-up will be executed (Preoperative, 4 weeks, 6 weeks, 3 months, 6 months and 12 months). The outcomes measurements are: 1. Functional, self reported: DASH (Disabilities of arm, shoulder and Hand questionnaire) and Short-Form 36 health surveys; 2. Functional. Objective measurements: radiological, strength and range of motion; 3. Complications and failure. Statistical methods: We have calculated 36 patients per intervention group. We have reached this sample size by considering a 95% confidence interval, with an 80% sample Power for detecting a 10-point difference in DASH scale. Therefore, for this study we have reached a total of 80 patients enrolling our study, considering 10% of follow-up losses. (AU)