Questionnaires
Baseline data are recorded preoperatively both by the surgeon and the patient (e.g. age, sex, co-morbidity, length, weight and smoking habits).
To inventory pre- and postoperative symptoms and problems objectively, special questionnaires have been designed. Since no proper validated questionnaire about implant removal exists, questions have been obtained from the validated and generally accepted ‘Disabilities of the Arm, Shoulder and Hand (DASH) scoring system’ [
4], which appears to be also suitable for the lower extremity [
5] and the ‘Medical Outcomes Study Short Form-36 (SF-36) scores’ [
6]. Using the DASH score, evaluation of activities of daily living, social activities, work activities, symptoms, sleeping and confidence is possible. The SF-36 measures physical functioning, limitations in daily activities as result of physical health problems, pain, general health perceptions, vitality and social functioning. Questions about expectations and satisfaction of the result of the implant removal have been designed for both surgeon and patient.
The surgeon answers the questionnaire at six different time points; starting preoperatively after obtaining the informed consent, immediately after the surgical procedure, two weeks postoperatively, after six weeks, after six months in all patients and after one year in case of plate removal (Table
1). The reason for a follow up of one year in case of plate removal is the presumed higher risk of a refracture. A follow up of six months after nail removal is supposed to be long enough to get a reliable overview of possible postoperative complications.
Table 1
Follow up schedule
Questionnaire patient | x | | | x | x | x |
Questionnaire surgeon | x | x | x | x | x | x |
Clinical examination | x | | x | x | x | x |
X-ray | x | | x | | x | x |
Surgery related complications (e.g. haemoraghe, infection, nerve damage, poor cosmetic result and refracture) are defined and recorded during the follow up,
Additional file 1. The peroperative questionnaire contains questions about the background and level of experience of the performing surgeon, type of anesthesia, use of a tourniquet and antibiotics, type of incision, ease of finding the implant, ease of removing the implant, use of extra instruments for removal, (time) use of fluoroscopy, peroperative complications, estimated blood loss, duration of the procedure (skin to skin), overall satisfaction of the surgeon and grade of difficulty of the surgical procedure according to the surgeon.
Patients fill in their part of the questionnaire preoperatively during the first intake at the outpatient clinic, six weeks postoperatively, after six months and, in case of plate removal after one year (Table
1). These questionnaires contain general questions on length, weight and smoking habits and specific questions about the complaints related to the implant (e.g. pain, swelling, loss of strength, functional impairment). Complaints are rated on a visual analog Likert-scale from 1 (no) to 5 (extreme). Finally, patients are asked to rate the cosmetic aspects of their scar pre- and postoperatively (after six months) on a visual analog scale from 0 (very ugly) to 10 (very beautiful). Both surgeon and patient are asked about their overall satisfaction of the implant removal, if expectations have become truth and if they would perform or undergo the procedure again and why.
Inclusion criteria
Only adults (≥ 18 years) with a clinically and radiologically healed fracture after a plate- or intramedullary nail osteosynthesis of the upper extremity (radius, ulna, humerus, clavicle) or lower extremity (femur, tibia) with an ASA-classification of I, II or III according to the American Society of Anaesthesiologists [
8] and a signed informed consent (after agreement on removal) are included.
Exclusion criteria
Excluded are all patients younger than 18 years, ASA-classification IV and V, patients with a nonunion and/or infection, patients with implants in other than above mentioned bones and all patients without informed consent.
All adult patients (≥ 18 years) in the six participating hospitals with a clinically and radiologically healed fracture of the clavicle, humerus, radius, ulna, femur or tibia (proximal, midshaft or distal), who have been treated with a plate or nail osteosynthesis, are invited to participate in the study. Healed fractures of the hand, acetabulum, spine or feet are left out of the study because of the low incidence. Also any osteosynthesis of the fibula are not encountered in the study because there hardly is any discussion about implant removal of fibula osteosynthesis in case of complaints. We choose to include clinically and/or radiologically healed fractures and not for a minimum time period between the fracture treatment and the implant removal, nor was confirmation of consolidation by a CT-scan required. It was presumed that this will resemble daily clinical practice most reliably. Patients can be symptomatic, but also reasons like ‘the implant doesn’t belong in my body’ and ‘I want to get it out’ are accepted reasons for implant removal. After a general informed consent on the standard removal procedure by the surgeon and a decision by patient to have the implant removed, the surgeon informs the patient verbally about this study. In case of interest, the patient is subsequently offered a written information letter. After agreement on participation the patient is asked to sign a written informed consent form.
Intervention
The surgical procedure itself is performed in a normal daily practice to minimize any form of bias because of the study. This means that the surgery can be performed under general, regional or local anaesthesia. The operating surgeon is a graduated general-, trauma- or orthopaedic surgeon or a resident in training for one of these specialties. The surgeon is free to use fluoroscopy, antibiotics, a tourniquet and thrombosis prophylaxis, according to his local hospital protocol. Also the surgeon decides on the postoperative treatment, like weight bearing and the resumption of work or sport activities. Postoperative pain is treated according to the normal guidelines of the participating hospitals (paracetamol, NSAID’s, morphine).