Citation

Hagenaars T, Van Oijen GW, Roerdink WH, Vegt PA, Vroemen JP, Verhofstad MH, van Lieshout EM. BMC Musculoskelet. Disord. 2016; 17(1): e235.

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.

Copyright

(Copyright © 2016, Holtzbrinck Springer Nature Publishing Group - BMC)

DOI

10.1186/s12891-016-1077-9

PMID

27233355

PMCID

PMC4882870

Abstract

BACKGROUND: 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®.

METHODS/DESIGN: 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.

DISCUSSION: 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. TRIAL REGISTRATION: The study is registered at the Netherlands Trial Register ( NTR5457 ; 29-sep-2015).

Language: en