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

BMC Musculoskeletal Disorders

Chris van der Werken⁵  Yolanda van der Graaf⁴  Beate Hanson¹  Michael HJ Verhofstad²  Dagmar I Vos³ 

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

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

Others  :  1146004
DOI  :  10.1186/1471-2474-13-147

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

【 摘 要 】

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

【 授权许可】

   
2012 Vos et al.; licensee BioMed Central Ltd.

【 参考文献 】

• [1]Bae JH, Oh JK, Oh CW, Hur CR: Technical difficulties of removal of locking screw after locking compression plating. Arch Orthop Trauma Surg 2009, 129(1):91-95.
• [2]Minkowitz RB, Bhadsavle S, Walsh M, Egol KA: Removal of painful orthopaedic implants after fracture union. J Bone Joint Surg Am 2007, 89(9):1906-1912.
• [3]Richards RH, Palmer JD, Clarke NM: Observations on removal of metal implants. Injury 1992, 23(1):25-28.
• [4]Hudak PL, Amadio PC, Amadio C: Am J Ind Med. 1996, 29(6):602-608.
• [5]Dowrick AS, Gabbe BJ, Williamson OD, Cameron PA: Does the disabilities of the arm, shoulder and hand (DASH) scoring system only measure disability due to injuries to the upper limb? J Bone Joint Surg Br 2006, 88(4):524-527.
• [6]Ware B: Overview of the SF-36 Health Survey and the International Quality of Life Assessment (IQOLA) Project. J Clin Epidemiol 1998, 51(11):903-912.
• [7]Ryf C, Weymann A: Range of motion : AO Neutral-0 Method : measurement and documentation = AO Neutral-0 Methode : messung und dokumentation. Thieme, Stuttgart, New York; 1999.
• [8]Saklad M: Grading of patients for surgical procedures. Anesthesiology 1941, 2:281-284. update: http://www.asahq.org/For-Members/Clinical-Information/ASA-Physical-Status-Classification-System.aspx webcite
• [9]Langkamer VG, Ackroyd CE: Removal of forearm plates. A review of the complications. J Bone Joint Surg Br 1990, 72(4):601-604.