Functional recovery after treatment of extra-articular distal radius fractures in the elderly using the IlluminOss® System (IO-Wrist); a multicenter prospective observational study

BMC Musculoskeletal Disorders

Study Protocol

Paul A. Vegt¹  Jos P. A. M. Vroemen²  W. Herbert Roerdink³  Esther M. M. Van Lieshout⁴  Michael H. J. Verhofstad⁴  Guido W. Van Oijen⁴  Tjebbe Hagenaars⁴ 

[1] Department of Surgery, Albert Schweitzer Hospital, P.O. Box 444, 3300, Dordrecht, AK, The Netherlands;Department of Surgery, Amphia Hospital, P.O. Box 90158, 4800, Breda, RK, The Netherlands;Department of Surgery, Deventer Hospital, P.O. Box 5001, 7400, Deventer, GC, The Netherlands;Trauma Research Unit Department of Surgery, Erasmus MC, University Medical Center Rotterdam, P.O. Box 2040, 3000, Rotterdam, CA, The Netherlands;

关键词: Costs;    Distal radius fracture;    Elderly;    Extra-articular;    Fracture;    Intramedullary;    Outcome;   

DOI  :  10.1186/s12891-016-1077-9

 received in 2015-12-22, accepted in 2016-05-13,  发布年份 2016

来源: Springer

【 摘 要 】

BackgroundApproximately 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®.Methods/designThe 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.DiscussionThe 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.Trial registrationThe study is registered at the Netherlands Trial Register (NTR5457; 29-sep-2015).

【 授权许可】

CC BY   
© Hagenaars et al. 2016