Abstract
BackgroundThe clinical results of removal of metal implants after fracture healing are unknown and the question whether to remove or to leave them in is part of discussion worldwide. We present the design of a prospective clinical multicentre cohort study to determine the main indications for and expectations of implant removal, the influence on complaints, the incidence of surgery related complications and the socio-economic consequences of implant removal.Methods/DesignIn a prospective multicentre clinical cohort study at least 200 patients with a healed fracture after osteosynthesis with a metal implant are included for analyzing the outcome after removal. Six hospitals in the Netherlands are participating. Special questionnaires are designed. The follow up after surgery will be at least six months. The primary endpoint is the incidence of surgery related complications. Secondary endpoints are the influence of removal on preoperative symptoms and complaints and the socio-economic consequences.DiscussionBy performing this study we hope to find profound arguments to remove or not to remove metal implants after fracture healing that can help to develop clear guidelines for daily practice.Trial registrationNTR1297, http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=1297
Highlights
The clinical results of removal of metal implants after fracture healing are unknown and the question whether to remove or to leave them in is part of discussion worldwide
The purpose of this study is (1) to analyse the incidence of surgery related complications, (2) to determine the main indications for implant removal, (3) to analyse the clinical effect on preoperative symptoms and complaints of the patient related to the implant, (4) to determine if the clinical effect of removal meets the main expectations of the patient and the surgeon and (5) to analyse the socio-economic consequences, like the amount of days of absence from work or school due to implant removal
Symptomatic patients with problems and/or complaints that are possibly related to the presence of a metal implant generally wish its removal anyway and likewise the patient and the surgeon would not be motivated to participate in a randomized trial
Summary
The clinical results of removal of metal implants after fracture healing are unknown and the question whether to remove or to leave them in is part of discussion worldwide. We present the design of a prospective clinical multicentre cohort study to determine the main indications for and expectations of implant removal, the influence on complaints, the incidence of surgery related complications and the socio-economic consequences of implant removal. In literature only three cohort studies on the results and complications of implant removal can be found [1,2,3]. The results of implant removal are unknown and the question whether to remove or to leave metal implants after fracture healing is part of an ongoing worldwide discussion.
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