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

BMC Musculoskeletal Disorders

Study Protocol

Beate Hanson¹  Dagmar I Vos²  Michael HJ Verhofstad³  Chris van der Werken⁴  Yolanda van der Graaf⁵ 

[1] AO Clinical Investigation and Documentation, Dubendorf, Switzerland;Department of Surgery, Amphia Hospital Breda, Breda, The Netherlands;Department of Surgery, St. Elisabeth Hospital, Tilburg, The Netherlands;Department of Surgery, University Medical Centre, Utrecht, The Netherlands;Julius Centre for Health Sciences and Primary Care, University Medical Centre, Utrecht, The Netherlands;

关键词: Implant removal;    Metal implants;    Fracture healing;    Fracture surgery;    Osteosynthesis;    Complications;    Complaints;   

DOI  :  10.1186/1471-2474-13-147

 received in 2012-05-02, accepted in 2012-08-07,  发布年份 2012

来源: Springer

【 摘 要 】

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

【 授权许可】

CC BY   
© Vos et al.; licensee BioMed Central Ltd. 2012