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Open Access Study protocol

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

Dagmar I Vos1*, Michael HJ Verhofstad2, Beate Hanson3, Yolanda van der Graaf4 and Chris van der Werken5

Author Affiliations

1 Department of Surgery, Amphia Hospital Breda, Breda, the Netherlands

2 Department of Surgery, St. Elisabeth Hospital, Tilburg, the Netherlands

3 AO Clinical Investigation and Documentation, Dubendorf, Switzerland

4 Julius Centre for Health Sciences and Primary Care, University Medical Centre, Utrecht, the Netherlands

5 Department of Surgery, University Medical Centre, Utrecht, the Netherlands

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BMC Musculoskeletal Disorders 2012, 13:147  doi:10.1186/1471-2474-13-147

Published: 15 August 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.

Trial registration

NTR1297, http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=1297 webcite

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