title: Functional recovery after treatment of extra-articular distal radius fractures in the elderly using the IlluminOss® System (IO-Wrist); a multicenter prospective observational study.
abstract: Approximately 17 % of all fractures involve the distal radius. Two-thirds require reduction due to displacement. High redislocation rates and functional disability remain a significant problem after non-operative treatment, with up to 30 % of patients suffering long-term functional restrictions. Whether operative correction is superior to non-operative treatment with respect to functional outcome has not unequivocally been confirmed. The IlluminOss® System was introduced in 2009 as a novel, patient-specific, and minimally invasive intramedullary fracture fixation. This minimally invasive technique has a much lower risk of iatrogenic soft tissue complications. Because IlluminOss® allows for early mobilization, it may theoretically lead to earlier functional recovery and ADL independence than non-operative immobilization. The main aim of this study is to examine outcome in elderly patients who sustained a unilateral, displaced, extra-articular distal radius fracture that was treated with IlluminOss®.
  
  
  
  The design of the study will be a multicenter, prospective, observational study (case series). The study population comprises elderly (60 years or older; independent in activities of daily living) with a unilateral, displaced, extra-articular distal radius fracture (AO/OTA type 23-A2 and A3) that after successful closed reduction was fixed within 2 weeks after the injury with IlluminOss®. Critical elements of treatment will be registered, and outcome will be monitored until 1 year after surgery. The Disabilities of the Arm, Shoulder, and Hand score will serve as primary outcome measure. The Patient-Rated Wrist Evaluation score, level of pain, health-related quality of life (Short Form-36 and EuroQoL-5D), time to ADL independence, time to activities/work resumption, range of motion of the wrist, radiological outcome, and complications are secondary outcome measures. Health care consumption and lost productivity will be used for a cost analysis. The cost analysis will be performed from a societal perspective. Descriptive data will be reported.
  
  
  
  The results of this study will provide evidence on the effectiveness of operative treatment of patients who sustained an extra-articular distal radius fracture with the IlluminOss® System, using clinical, patient-reported, and societal outcomes.
  
  
  
  The study is registered at the Netherlands Trial Register ( NTR5457 ; 29-sep-2015).
authors.affiliation: Trauma Research Unit Department of Surgery, Erasmus MC, University Medical Center Rotterdam, P.O. Box 2040, Rotterdam, CA, 3000, The Netherlands.
authors.forename: Tjebbe
authors.initials: T
authors.lastname: Hagenaars
authors.affiliation: Trauma Research Unit Department of Surgery, Erasmus MC, University Medical Center Rotterdam, P.O. Box 2040, Rotterdam, CA, 3000, The Netherlands.
authors.forename: Guido W
authors.initials: GW
authors.lastname: Van Oijen
authors.affiliation: Department of Surgery, Deventer Hospital, P.O. Box 5001, Deventer, GC, 7400, The Netherlands.
authors.forename: W Herbert
authors.initials: WH
authors.lastname: Roerdink
authors.affiliation: Department of Surgery, Albert Schweitzer Hospital, P.O. Box 444, Dordrecht, AK, 3300, The Netherlands.
authors.forename: Paul A
authors.initials: PA
authors.lastname: Vegt
authors.affiliation: Department of Surgery, Amphia Hospital, P.O. Box 90158, Breda, RK, 4800, The Netherlands.
authors.forename: Jos P A M
authors.initials: JP
authors.lastname: Vroemen
authors.affiliation: Trauma Research Unit Department of Surgery, Erasmus MC, University Medical Center Rotterdam, P.O. Box 2040, Rotterdam, CA, 3000, The Netherlands.
authors.forename: Michael H J
authors.initials: MH
authors.lastname: Verhofstad
authors.affiliation: Trauma Research Unit Department of Surgery, Erasmus MC, University Medical Center Rotterdam, P.O. Box 2040, Rotterdam, CA, 3000, The Netherlands. e.vanlieshout@erasmusmc.nl.
authors.forename: Esther M M
authors.initials: EM
authors.lastname: Van Lieshout
mesh_terms: D005594:Fracture Fixation, Intramedullary / Q000295:instrumentation*; D006801:Humans; D019060:Minimally Invasive Surgical Procedures / Q000295:instrumentation; D000071066:Patient Reported Outcome Measures; D011446:Prospective Studies; D011885:Radius Fractures / Q000601:surgery*; D020127:Recovery of Function; D012107:Research Design; D014954:Wrist Injuries / Q000601:surgery*
keywords: Costs; Distal radius fracture; Elderly; Extra-articular; Fracture; Intramedullary; Outcome