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1.  Wound Infections Following Implant removal below the knee: the effect of antibiotic prophylaxis; the WIFI-trial, a multi-centre randomized controlled trial 
BMC Surgery  2015;15:12.
In the Netherlands about 18,000 procedures with implant removal are performed annually following open or closed reduction and fixation of fractures, of which 30-80% concern the foot, ankle and lower leg region. For clean surgical procedures, the rate of postoperative wound infections (POWI) should be less than ~2%. However, rates of 10-12% following implant removal have been reported, specifically after foot, ankle and lower leg fractures. Currently, surgeons individually decide if antibiotics prophylaxis is given, since no guideline exists. This leads to undesirable practice variation. The aim of the study is to assess the (cost-)effectiveness of a single intravenous gift of Cefazolin prior to implant removal following surgical fixation of foot, ankle and/or lower leg fractures.
This is a double-blind randomized controlled trial in patients scheduled for implant removal following a foot, ankle or lower leg fracture. Primary outcome is a POWI within 30 days after implant removal. Secondary outcomes are quality of life, functional outcome and costs at 30 days and 6 months after implant removal. With 2 x 250 patients a decrease in POWI rate from 10% to 3.3% (expected rate in clean-contaminated elective orthopaedic trauma procedures) can be detected (Power = 80%, 2-sided alpha = 5%, including 15% lost to follow up).
If administration of prophylactic antibiotics prior to implant removal reduces the infectious complication rate, this will offer a strong argument to adopt this as standard practice of care. This will consequently lead to less physical and social disabilities and health care use. A preliminary, conservative estimation suggests yearly cost savings in the Netherlands of € 3.5 million per year.
Trial registration
This study is registered at (NCT02225821) and the Netherlands Trial Register (NTR4393) and was granted permission by the Medical Ethical Review Committee of the Academic Medical Centre on October 7 2014.
PMCID: PMC4429659  PMID: 25972101
Antibiotic prophylaxis; Postoperative wound infection; Implant removal; Fracture surgery; Functional outcome
2.  Outcome after osteosynthesis of hip fractures in nonagenarians 
Hip fractures in the elderly population are associated with high morbidity and mortality. However, there is still a lack of information on mortality and loss of independence in extremely elderly people with a hip fracture.
To study functional outcomes and mortality after osteosynthesis of hip fractures in very old patients in our clinic.
Patients and methods
Hospital charts of all patients over 90 years old who were operated for a hip fracture between January 2007 and December 2011 were reviewed. Outcome measures were mortality, preoperative and postoperative mobility, and loss of independence.
A total of 149 patients were included; 132 (89%) women, median age 93.5±2.45 years. Thirty-six (24%) patients were classified as American Society of Anesthesiologists (ASA) grade 2, 104 (70%) as ASA grade 3, and nine (6%) as ASA grade 4. The Charlson comorbidity index (CCI) score was 2 or less in 115 (77%) patients and 34 (23%) patients scored 3 or more points. Short-term survival was 91% and 77% at 30 days and 3 months, respectively. Long-term survival was 64%, 42%, and 18% at 1, 3, and 5 years after surgery, respectively. Survival was significantly better in patients with lower ASA scores (P=0.005). No significant difference in survival was measured between patients according to CCI score (P=0.13). Fifty-one percent of patients had to be accommodated in an institution with more care following treatment, and 57% were less mobile after osteosynthesis of a hip fracture.
Our study shows that short-term mortality rates in very elderly patients with a hip fracture are high and there is no clear predictive value for mortality. ASA classification is the best predictive value for overall mortality. A large proportion of these patients lost their independence after osteosynthesis of a hip fracture.
PMCID: PMC3872008  PMID: 24379658
hip fracture; osteosynthesis; very elderly people; mortality; loss of independence
3.  Clinical outcome of implant removal after fracture healing. Design of a prospective multicentre clinical cohort study 
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.
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.
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
PMCID: PMC3493388  PMID: 22894749
Implant removal; Metal implants; Fracture healing; Fracture surgery; Osteosynthesis; Complications; Complaints
4.  Implant removal of osteosynthesis: the Dutch practice. Results of a survey 
The aim of this survey study was to evaluate the current opinion and practice of trauma and orthopaedic surgeons in the Netherlands in the removal of implants after fracture healing.
A web-based questionnaire consisting of 44 items was sent to all active members of the Dutch Trauma Society and Dutch Orthopaedic Trauma Society to determine their habits and opinions about implant removal.
Though implant removal is not routinely done in the Netherlands, 89% of the Dutch surgeons agreed that implant removal is a good option in case of pain or functional deficits. Also infection of the implant or bone is one of the main reasons for removing the implant (> 90%), while making money was a motivation for only 1% of the respondents. In case of younger patients (< 40 years of age) only 34% of the surgeons agreed that metal implants should always be removed in this category. Orthopaedic surgeons are more conservative and differ in their opinion about this subject compared to general trauma surgeons (p = 0.002). Though the far majority removes elastic nails in children (95%).
Most of the participants (56%) did not agree that leaving implants in is associated with an increased risk of fractures, infections, allergy or malignancy. Yet in case of the risk of fractures, residents all agreed to this statement (100%) whereas staff specialists disagreed for 71% (p < 0.001). According to 62% of the surgeons titanium plates are more difficult to remove than stainless steel, but 47% did not consider them safer to leave in situ compared to stainless steel. The most mentioned postoperative complications were wound infection (37%), unpleasant scarring (24%) and postoperative hemorraghe (19%).
This survey indicates that there is no general opinion about implant removal after fracture healing with a lack of policy guidelines in the Netherlands. In case of symptomatic patients a majority of the surgeons removes the implant, but this is not standard practice for every surgeon.
PMCID: PMC3485133  PMID: 22863279
Osteosynthesis; Implant removal; Survey; Complaints; Fracture healing
5.  Displaced midshaft fractures of the clavicle: non-operative treatment versus plate fixation (Sleutel-TRIAL). A multicentre randomised controlled trial 
The traditional view that the vast majority of midshaft clavicular fractures heal with good functional outcomes following non-operative treatment may be no longer valid for all midshaft clavicular fractures. Recent studies have presented a relatively high incidence of non-union and identified speciic limitations of the shoulder function in subgroups of patients with these injuries.
A prospective, multicentre randomised controlled trial (RCT) will be conducted in 21 hospitals in the Netherlands, comparing fracture consolidation and shoulder function after either non-operative treatment with a sling or a plate fixation.
A total of 350 patients will be included, between 18 and 60 years of age, with a dislocated midshaft clavicular fracture. The primary outcome is the incidence of non-union, which will be determined with standardised X-rays (Antero-Posterior and 30 degrees caudocephalad view). Secondary outcome will be the functional outcome, measured using the Constant Score. Strength of the shoulder muscles will be measured with a handheld dynamometer (MicroFET2). Furthermore, the health-related Quality of Life score (ShortForm-36) and the Disabilities of Arm, Shoulder and Hand (DASH) Outcome Measure will be monitored as subjective parameters. Data on complications, bone union, cosmetic aspects and use of painkillers will be collected with follow-up questionnaires. The follow-up time will be two years. All patients will be monitored at regular intervals over the subsequent twelve months (two and six weeks, three months and one year). After two years an interview by telephone and a written survey will be performed to evaluate the two-year functional and mechanical outcomes. All data will be analysed on an intention-to-treat basis, using univariate and multivariate analyses.
This trial will provide level-1 evidence for the comparison of consolidation and functional outcome between two standardised treatment options for dislocated midshaft clavicular fractures. The gathered data may support the development of a clinical guideline for treatment of clavicular fractures.
Trial registration
Netherlands National Trial Register NTR2399
PMCID: PMC3175212  PMID: 21864352

Results 1-5 (5)