Clinical outcome of implant removal after fracture healing. Design of a prospective multicentre clinical cohort study.
BACKGROUND
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.


METHODS
In 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.


CONCLUSIONS
By 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.


BACKGROUND
NTR1297, http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=1297.
Department of Surgery, Amphia Hospital Breda, Breda, the Netherlands. dvos@amphia.nl
Dagmar I
DI
Vos
Michael H J
MH
Verhofstad
Beate
B
Hanson
Yolanda
Y
van der Graaf
Chris
C
van der Werken
D020878:Device Removal / Q000009:adverse effects / Q000191:economics; D005593:Fracture Fixation, Internal / Q000009:adverse effects / Q000191:economics / Q000295:instrumentation*; D017102:Fracture Healing; D050723:Fractures, Bone / Q000000981:diagnostic imaging / Q000601:surgery*; D017048:Health Care Costs; D006801:Humans; D016268:Internal Fixators; D008670:Metals; D009426:Netherlands; D011183:Postoperative Complications / Q000209:etiology; D011446:Prospective Studies; D011474:Prosthesis Design; D011859:Radiography; D012107:Research Design; D012959:Socioeconomic Factors; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome
D008670:Metals