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

Tjebbe Hagenaars, Guido W Van Oijen, W Herbert Roerdink, Paul A Vegt, Jos P A M Vroemen, Michael H J Verhofstad, Esther M M Van Lieshout, Tjebbe Hagenaars, Guido W Van Oijen, W Herbert Roerdink, Paul A Vegt, Jos P A M Vroemen, Michael H J Verhofstad, Esther M M Van Lieshout

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).

Keywords: Costs; Distal radius fracture; Elderly; Extra-articular; Fracture; Intramedullary; Outcome.

Figures

Fig. 1
Fig. 1
Using the IlluminOss® System for fixating a distal radius fracture*. a 1.5–2.0 cm incision over the radial styloid process, between the first and second extensor compartment to reach the periosteum. The superficial branches of the radial nerve are protected. b Access to the medullary canal and insertion of a 1.5 mm guide-wire. c Correct position is verified by intra-operative fluoroscopy. d Flexible balloon catheter is placed intramedullary over the guide-wire spanning the fracture. e Infusion of liquid monomeric material and expansion of the balloon conforming to the patient’s unique medullary canal. f Verification of adequate fracture reduction, correct balloon position, and balloon expansion. g Polymerization (hardening) of the infused monomer by applying visible (436 nm) light, creating a patient specific intramedullary implant. * (Photographs and radiographs are used with permission of the patient)

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