Are Routine Radiographs Needed the Day After Open Reduction and Internal Fixation Surgery for Distal Radius and Ankle Fractures: Study Protocol for a Prospective, Open Label, Randomized Controlled Trial

摘要

Background Distal radius and ankle fractures are one of the most common operatively treated fractures. To date, there is no consensus concerning the need for a standard postoperative radiograph. This leads to undesirable practice variations. A standardized radiograph in the department of radiology would theoretically be more reproducible and operator independent than an intraoperatively obtained fluoroscopic image. However, if adequate intraoperative radiographs have been obtained, it is questionable if these postoperative radiographs are necessary and will lead to changes in the treatment strategy. If standard postoperative radiographs are no longer required, this would lead to a reduction in radiation exposure and health care costs. The hypothesis is that routine standardized postoperative radiographs do not influence the quality of care for patients operated on for either a distal radius or an ankle fracture if adequate intraoperative standardized radiographs have been obtained. Objective The primary aim of this study is to evaluate if there is a need for routine postoperative radiographs after an osteosynthesis of a distal radius or ankle fracture. Methods In a prospective, randomized controlled, open label trial based on a noninferiority design, we will enroll 332 patients. Patients will be randomized either in the control or the intervention group. The control group will be treated according to our current, standard protocol in which all patients receive a standard anterior-posterior and lateral radiograph on the first postoperative day. Patients randomized to the intervention group will be treated without a standard postoperative radiograph. All patients (N=332) will have a routine clinical and radiographic control after 6 weeks in the outpatient clinic. Primary outcome is a change in treatment plan, defined as either additional imaging or a reoperation based on the postoperative imaging. Secondary outcome measures include a 36-Item Short Form Survey, Patient-Rated Wrist Hand Evaluation, Foot and Ankle Outcome Score, Visual Analogue Scale, and the range of motion. Those questionnaires will be filled out at the 6-week outpatient control. Results The trial was started in August 2016, and 104 patients have been enrolled up to this point. Conclusions Our findings will be reported in peer-reviewed publications and may lead to a strong reduction in radiation exposure and health care costs. A preliminary, conservative estimation suggests a yearly cost saving of CHF 1.3 million in Switzerland.