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Logo of bmcmudisBioMed Centralsearchsubmit a manuscriptregisterthis articleBMC Musculoskeletal Disorders
 
BMC Musculoskelet Disord. 2012; 13: 147.
Published online Aug 15, 2012. doi:  10.1186/1471-2474-13-147
PMCID: PMC3493388
Clinical outcome of implant removal after fracture healing. Design of a prospective multicentre clinical cohort study
Dagmar I Vos,corresponding author1 Michael HJ Verhofstad,2 Beate Hanson,3 Yolanda van der Graaf,4 and Chris van der Werken5
1Department of Surgery, Amphia Hospital Breda, Breda, the Netherlands
2Department of Surgery, St. Elisabeth Hospital, Tilburg, the Netherlands
3AO Clinical Investigation and Documentation, Dubendorf, Switzerland
4Julius Centre for Health Sciences and Primary Care, University Medical Centre, Utrecht, the Netherlands
5Department of Surgery, University Medical Centre, Utrecht, the Netherlands
corresponding authorCorresponding author.
Dagmar I Vos: dvos/at/amphia.nl; Michael HJ Verhofstad: m.verhofstad/at/elisabeth.nl; Beate Hanson: beate.hanson/at/aofoundation.org; Yolanda van der Graaf: Y.vanderGraaf/at/umcutrecht.nl; Chris van der Werken: C.Werken/at/umcutrecht.nl
Received May 2, 2012; Accepted August 7, 2012.
Abstract
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/Design
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.
Discussion
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.
Keywords: Implant removal, Metal implants, Fracture healing, Fracture surgery, Osteosynthesis, Complications, Complaints
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