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

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.

Lateral insertion points in antegrade femoral nailing and their influence on femoral bone strains.

OBJECTIVES: Insertion of rigid uniplane bent femoral nails through the piriform fossa has been reported to cause neurovascular complications. New nails were designed for more lateral entry points. However, these may be associated with a higher risk of iatrogenic fractures. This study investigated if two differently bent nails with more lateral entry points induce higher cortical bone strains than a uniplane bent nail introduced through the piriform fossa. METHODS: Three groups of 8 cadaveric femurs were instrumented using the following nail systems and entry points: Cannulated Femoral Nail, piriform fossa; Antegrade Femoral Nail, trochanteric tip; and helical nail, lateral of the trochanteric tip. During insertion, the maximum principal bone strains were recorded at 9 locations at the proximal femur and the diaphysis. The occurrence of iatrogenic fractures or fissures was documented. RESULTS: The highest strains recorded were between 2000 and 4500 mum/m and mainly located at the posterior aspect of the greater trochanter and at the medial side of the entry point. In most of these cases fissures or fractures occurred, the number of which was higher for the trochanteric tip group as compared with the other groups. This was thought to be due to the thin cortical walls as a result of the larger reamer diameter in this group. Low strains (below 2000 microm/m) occurred at the medial cortex where the laterally inserted nails were expected to impinge. CONCLUSIONS: Bone strains at the medial impingement location were low for all nails. Entry portals with thin cortical walls due to, for example, larger reamer diameters and a small greater trochanter seem to be more susceptible to insertion accuracy, which may influence strain and fissure or fracture occurrence. Furthermore, we do not recommend determination of the entry point of laterally inserted nails based solely on anatomic landmarks of the greater trochanter because this may influence insertion accuracy. This implies that biplanar imaging is important for accurate and safe insertion of laterally started nails.

Low-intensity pulsed ultrasound (LIPUS) in fresh clavicle fractures: a multi-centre double blind randomised controlled trial.

BACKGROUND: Several randomised trials have been published on the effect of low-intensity pulsed ultrasound (LIPUS) on fracture healing in both distal radius and tibia fractures. Most studies showed a positive effect on time to clinical and radiological healing. We hypothesised that LIPUS has a beneficial effect on the healing of fresh clavicle fractures as well and studied its effect in non-operatively treated shaft fractures. METHODS: We conducted a randomised double blind, placebo-controlled multi-centre trial in 101 adult patients with a non-operatively treated fresh clavicle shaft fracture. Of these patients, 49 used a placebo transducer and 52 patients had an active transducer with ultrasound stimulation (Exogen 2000). Data were analysed on intention to treat basis. Baseline parameters of both groups were not significantly different. RESULTS: There were no differences in time to subjective clinical fracture healing, resumption of daily activities, sports or professional work, Visual Analogue pain Scores (VAS) and use of pain medication. CONCLUSION: Our findings did not confirm that LIPUS accelerates clinical healing time of fresh clavicle shaft fractures. LEVEL OF EVIDENCE: Level 1 evidence that low-intensity pulsed ultrasound does not accelerate clinical fracture healing in non-operatively treated fresh midshaft clavicle fractures.

Surgeons' beliefs and perceptions about removal of orthopaedic implants.

BACKGROUND: The routine removal of orthopaedic fixation devices after fracture healing remains an issue of debate. There are no evidence-based guidelines on this matter, and little is known on surgeons' practice and perceived effectiveness of implant removal in different clinical settings. METHODS: A 41-item questionnaire was distributed to 730 attendees of the AO Principles and Masters Courses of Operative Fracture Treatment in Davos, Switzerland, to assess their attitudes towards removal of different types of implants, and perceived benefits and risks with this common procedure. RESULTS: The response rate was 655/730 (89.7%), representing 54.6% of all 1199 course attendees. Surgeons from 65 countries (571 males and 84 females, mean age 39 +/- SD 9 years) took part in the survey. Fifty-eight percent of the participants did not agree that routine implant removal is necessary, and 49% and 58% did not agree that indwelling implants pose an excess risk for fractures or general adverse effects. Forty-eight percent felt that removal is riskier than leaving the implant in situ. Implant removal in symptomatic patients was rated to be moderately effective (mean rating on a 10-point-scale, 5.8, 95% confidence interval 5.7-6.0). Eighty-five percent of all participants agreed that implant removal poses a burden to hospital resources. Surgeons were undetermined whether implant removal is adequately reimbursed by payers of health care services (44% "I-don't-know"-answers). CONCLUSION: Many surgeons refuse a routine implant removal policy, and do not believe in clinically significant adverse effects of retained metal implants. Given the frequency of the procedure in orthopaedic departments worldwide, there is an urgent need for a large randomized trial to determine the efficacy and effectiveness of implant removal with regard to patient-centred outcomes.

Individual and population burdens of major trauma in the Netherlands.

OBJECTIVE: To assess the impact of major trauma on individual and population health. METHODS: Data from a regional trauma registry were used, including all trauma fatalities and nonfatal severely injured patients (injury severity score >15) in 1999 and 2000. The impact of fatalities was expressed in terms of years of life lost (YLL). The impact of severe injury on survivors was expressed in terms of years lived with disability (YLD). Disability weights were based on quality of life at 15 months after injury, measured with EuroQol-5D. Disability-adjusted life years (DALYs) were calculated as the sum of YLLs and YLDs. FINDINGS: There were 567 fatalities and 335 survivors. At the individual level, trauma fatalities (32 YLLs per patient) and nonfatal cases of major trauma (12 YLDs per patient) both led to a substantial loss of healthy life years. Each victim of major trauma contributed an average of 25 DALYs to the burden of disease. At the population level, major trauma caused 10 DALYs per 1000 inhabitants. Road-traffic injury was the main contributor to the population burden of major trauma. CONCLUSION: Both at individual and population levels, major trauma has a massive impact on health. Most severely injured victims of road-traffic crashes reach the hospital and have good chances of survival. Injury prevention and trauma care policies should aim at further reduction of both fatalities and permanent consequences among survivors.

Return to work after major trauma.

OBJECTIVE: To quantify the prevalence of return to work after major trauma, and to investigate the determinants of postinjury work status. DESIGN: Prospective cohort study. SETTING: University Medical Centre Utrecht, a level 1 trauma centre in the Netherlands. METHOD: All severely injured (ISS > 16) adult (age = 16+) trauma survivors admitted from January 1999 to December 2000 who were full-time employed at the time of the injury were selected for follow-up (n = 214). Response rate was 93%. Outcome was assessed at a mean of 15 months (SD = 1.5) after injury. Multivariate logistic regression analyses identified determinants at hospital discharge and at follow-up. RESULTS: Following injury 58.4% of the patients (n = 125) were able to return to full-time employment, 21.5% had a part-time job, and 20.1% did not return to work. Univariate analysis yielded the following significant determinants of postinjury work status: age, comorbidity, injury severity score, brain injury, spinal cord injury, length of stay in an intensive care unit, hospital stay, discharge destination, percentage of permanent impairment (according to the fourth American Medical Association guide (AMA)), limitations in activities of daily living and cognitive complaints. Logistic regression analyses (23% explained variance) identified spinal cord injury, duration of hospital stay, discharge destination and age as determinants of return to work at hospital discharge. At follow-up, determinants of return to work included AMA, activities of daily living, cognitive complaints and being discharged home (51% explained variance). CONCLUSIONS: Around 60% of the patients returned to their pre-injury work status after major trauma. The return to work rate was only partly explained by disability at follow-up. Independent determinants of return to work differ with the time of assessment.

Methicillin-resistant Staphylococcus aureus carriage among patients after hospital discharge.

BACKGROUND AND OBJECTIVE: At the University Medical Center Utrecht (UMCU), follow-up implies an inventory of risk factors and screening for MRSA colonization among all MRSA-positive patients for at least 6 months. If risk factors or positive cultures persist or re-emerge, longer follow-up is indicated and isolation at readmission. This study investigated how long MRSA-positive patients remained colonized after hospital discharge and which risk factors were important. Furthermore, the results of eradication therapy were evaluated. DESIGN: All patients who were positive for MRSA at the UMCU between January 1991 and January 2001 were analyzed regarding carriage state, presence of risk factors for prolonged carriage of Staphylococcus aureus, and eradication treatment. RESULTS: A total of 135 patients were included in the study. The median follow-up time was 1.2 years. Eighteen percent of the patients were dismissed from follow-up 1 year after discharge. Only 5 patients were dismissed after 6 months. Among patients with no risk factors, eradication treatment was effective for 95% within 1 year. Among patients with persistent risk factors, treatment was effective for 89% within 2 years. CONCLUSIONS: Based on these findings, eradication therapy should be prescribed for all MRSA carriers, independent of the presence of risk factors. MRSA-positive patients should be evaluated for 6 months for the presence of risk factors and MRSA carriage. Screening for risk factors is important because intermittent MRSA carriage was found in a significant number of our patients. Patients with negative MRSA cultures and without risk factors for 12 months can be safely dismissed from follow-up.

DHS osteosynthesis for stable pertrochanteric femur fractures with a two-hole side plate.

The sliding hip screw is the implant of choice for the operative treatment of stable pertrochanteric femur fractures (AO classification 31-A.1). For this indication, a four-hole side plate with four bicortical screws is widely used to allow full weight bearing immediately after operation, but scientific support for the need of such a long side plate is not available. A shorter side plate is potentially less invasive. Therefore, we retrospectively evaluated all 148 consecutive patients (median age 80 years) with a stable pertrochanteric femur fracture who were treated between 1995 and 2001 with a dynamic hip screw (DHS) and a short (two-hole) side plate and immediate full weight bearing mobilisation. Although two wound hematomas and four wound infections occurred, 145 fractures healed radiologically without implant-related complications within 6 months. Two hip screws cut out of the femoral head due to a poor position. In one patient, the side plate broke out after a fall out of bed on the fifth postoperative day. Pull off of any two-hole side plate during early full weight bearing mobilisation without further trauma was not observed. We conclude that fixation of stable pertrochanteric femur fractures with a two-hole DHS is safe. The traditional use of a four-hole DHS plate for this indication is therefore 'over-treatment' since it is more invasive.

Trauma care systems in The Netherlands.

In the late 1980s the Dutch trauma surgeons (Dutch Trauma Society) expressed their concern about the quality of care to the (multi) trauma patients, in the prehospital as well as the in-hospital setting. The following intensive debate with the public health inspectorate and the government became the start point for major improvements in teaching and training (a.o. ATLS), reorganization, regionalization and implementation in which all partners in trauma care were involved. The regionalization of ambulance care, the introduction of mobile medical teams, the availability of trauma helicopters, the categorization of hospitals, the designation of trauma centres, the given responsibility of these centres in the regionalization of trauma care will and already have resulted in an important quality improvement, not only of the individual organizations but for all of the entire chain of trauma care. It has become a major step forward in the philosophy: get the individual trauma patient at the right time at the right hospital. Besides, initiatives have been taken to design a nationwide trauma registration data base in which all in-hospital trauma patients will be included. However serious concerns remain: shortage of intensive care beds, the impossibility to use the helicopter service at night, the shortage in the number of mobile medical teams at night and the slowness in executions of agreements between contracting parties. Many of the remaining problems are a matter of money. Not only (para) medical partners and hospitals but for all government and insurance companies should take their responsibility in this.

Is methicillin-resistant Staphylococcus aureus more contagious than methicillin-susceptible S. aureus in a surgical intensive care unit?

BACKGROUND AND OBJECTIVE: In the Netherlands, the prevalence of methicillin resistance among Staphylococcus aureus isolates has been kept to less than 1% by using active screening programs and isolation. At the University Medical Center Utrecht (UMCU), an active screening program for methicillin-resistant S. aureus (MRSA) in the surgical intensive care unit (ICU) was implemented in 1986. Between 1992 and 2001, only 6 patients with MRSA were admitted to the surgical ICU. However, 4 of these 6 strains were able to spread to 23 other patients and 15 healthcare workers (HCWs). We were surprised by the epidemic behavior of these strains and wondered whether this was exceptional for S. aureus or whether methicillin-susceptible S. aureus (MSSA) was also spreading in the ICU. DESIGN: A 2-month, prospective, observational study to investigate the incidence and spread of MSSA in the surgical ICU of UMCU and historical data collected during a 10-year period regarding MRSA. SETTING: A 10-bed surgical ICU in a 1,042-bed teaching hospital. RESULTS: Weekly swabs revealed the presence of MSSA in 11 (24%) of 45 patients and 16 (22%) of 72 HCWs. Of all 4,105 patient-HCW contacts, there were only 21 episodes in which both the patient and the HCW were found to carry MSSA. With the use of pulsed-field gel electrophoresis, no identical strains could be identified. CONCLUSION: In our surgical ICU, MRSA seems to spread more easily than MSSA, probably because of selection under antibiotic pressure or a still unknown intrinsic factor within MRSA.