title: Treatment of reducible unstable fractures of the distal radius: randomized clinical study comparing the locked volar plate and external fixator methods: study protocol.
abstract: BACKGROUND
  Various treatments are available for reducible unstable fractures of the distal radius, such as closed reduction combined with fixation by external fixator (EF), and rigid internal fixation using a locked volar plate (VP). Although there are studies comparing these methods, there is no conclusive evidence indicating which treatment is best. The hypothesis of this study is that surgical treatment with a VP is more effective than EF from the standpoint of functional outcome (patient-reported).
  
  
  METHODS
  The study is randomized clinical trial with parallel groups and a blinded evaluator and involves the surgical interventions EF and VP. Patients will be randomly assigned (assignment ratio 1:1) using sealed opaque envelopes. This trial will include consecutive adult patients with an acute (up to 15 days) displaced, unstable fracture of the distal end of the radius of type A2, A3, C1, C2 or C3 by the Arbeitsgemeinschaft für Osteosynthesefragen-Association for the Study of Internal Fixation classification and type II or type III by the IDEAL32 classification, without previous surgical treatments of the wrist. The surgical intervention assigned will be performed by three surgical specialists familiar with the techniques described. Evaluations will be performed at 2, and 8 weeks, 3, 6 and 12 months, with the primary outcomes being measured by the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire and measurement of pain (Visual Analog Pain Scale and digital algometer). Secondary outcomes will include radiographic parameters, objective functional evaluation (goniometry and dynamometry), and the rate of complications and method failure according to the intention-to-treat principle. Final postoperative evaluations (6 and 12 months) will be performed by independent blinded evaluators. For the Student's t-test, a difference of 10 points in the DASH score, with a 95% confidence interval, a statistical power of 80%, and 20% sampling error results in 36 patients per group.
  
  
  CONCLUSIONS
  Results from this study protocol will improve the current evidence regarding to the surgical treatment these fractures.
  
  
  BACKGROUND
  ISCRTN09599740.
authors.affiliation: Hand, Arm and Shoulder Surgery Unit, Department of Orthopedics and Traumatology, Federal University of São Paulo, UNIFESP/EPM, São Paulo, SP, Brazil. raduan.neto@gmail.com.
authors.forename: Jorge
authors.initials: J
authors.lastname: Raduan Neto
authors.forename: Vinicius Ynoe
authors.initials: VY
authors.lastname: de Moraes
authors.forename: João B
authors.initials: JB
authors.lastname: Gomes Dos Santos
authors.forename: Flávio
authors.initials: F
authors.lastname: Faloppa
authors.forename: João Carlos
authors.initials: JC
authors.lastname: Belloti
mesh_terms: D000328:Adult; D001860:Bone Plates; D002985:Clinical Protocols; D016267:External Fixators; D005260:Female; D005500:Follow-Up Studies; D005592:Fracture Fixation / Q000295:instrumentation / Q000379:methods*; D005593:Fracture Fixation, Internal; D006801:Humans; D008297:Male; D018579:Patient Selection; D011859:Radiography; D011885:Radius Fractures / Q000000981:diagnostic imaging / Q000601:surgery*; D020127:Recovery of Function; D012720:Severity of Illness Index; D016037:Single-Blind Method; D064232:Visual Analog Scale