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1.  TEFTOM: A Promising General Trauma Expectation/Outcome Measure—Results of a Validation Study on Pan-American Ankle and Distal Tibia Trauma Patients 
ISRN Orthopedics  2013;2013:801784.
Background. In orthopedics, there is no instrument specifically designed to assess patients' expectations of their final surgery outcome in general trauma populations. We developed the Trauma Expectation Factor Trauma Outcome Measure (TEFTOM) to investigate the fulfilment of patients' expectations one year after surgery as a measure of general trauma surgical outcomes. The aim of this paper was to assess the psychometric characteristics of this new general trauma outcome measure. Methods. The questionnaire was tested in 201 ankle and distal tibia fracture patients scheduled for surgery. Patients were followed up for twelve months. The TEFTOM questionnaire was evaluated for its criterion validity, internal consistency, reproducibility, and responsiveness. Results. TOM showed good criterion validity against the American Academy of Orthopaedic Surgeons Foot and Ankle Scale (Pearson's correlation coefficient = 0.69–0.77). Internal consistency was acceptable for TEF (Cronbach's alpha = 0.65–0.76) and excellent for TOM (Cronbach's alpha = 0.76–0.85). Reproducibility was moderate to very good (intraclass coefficient correlation (ICC) ≥0.67) for TEF and very good (ICC ≥0.92) for TOM. TOM also proved to be responsive to changes in patients' condition over time (Wald test; P < 0.001). Conclusions. TEFTOM is a promising tool for measuring general trauma outcomes in terms of patients' expectation fulfilment that proved to be valid, internally consistent, reproducible, and responsive to change.
PMCID: PMC4045348  PMID: 24967116
2.  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
3.  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
4.  What should an ideal spinal injury classification system consist of? A methodological review and conceptual proposal for future classifications 
European Spine Journal  2010;19(8):1238-1249.
Since Böhler published the first categorization of spinal injuries based on plain radiographic examinations in 1929, numerous classifications have been proposed. Despite all these efforts, however, only a few have been tested for reliability and validity. This methodological, conceptual review summarizes that a spinal injury classification system should be clinically relevant, reliable and accurate. The clinical relevance of a classification is directly related to its content validity. The ideal content of a spinal injury classification should only include injury characteristics of the vertebral column, is primarily based on the increasingly routinely performed CT imaging, and is clearly distinctive from severity scales and treatment algorithms. Clearly defined observation and conversion criteria are crucial determinants of classification systems’ reliability and accuracy. Ideally, two principle spinal injury characteristics should be easy to discern on diagnostic images: the specific location and morphology of the injured spinal structure. Given the current evidence and diagnostic imaging technology, descriptions of the mechanisms of injury and ligamentous injury should not be included in a spinal injury classification. The presence of concomitant neurologic deficits can be integrated in a spinal injury severity scale, which in turn can be considered in a spinal injury treatment algorithm. Ideally, a validation pathway of a spinal injury classification system should be completed prior to its clinical and scientific implementation. This review provides a methodological concept which might be considered prior to the synthesis of new or modified spinal injury classifications.
PMCID: PMC2989196  PMID: 20464432
Spinal injury; Classification system; Severity measure; Treatment algorithm; Methodological review
5.  Can orthopedic trials change practice? 
Acta Orthopaedica  2010;81(1):122-125.
Background and purpose
The impact of large, randomized trials in orthopedic surgery on surgeons' preferences for a particular surgical approach remains unclear. We surveyed surgeons to assess whether they would change practice based upon results of a large, multicenter randomized controlled hip fracture trial.
We conducted a cross-sectional survey among International Hip Fracture Research Collaborative (IHFRC) surgeons and surgeons who were members of Arbeitsgemeinschaft fuer Osteosynthesefragen - Association for the Study of Internal Fixation (AO/ASIF) to determine the likelihood that they would change practice based on findings of a proposed large, multicenter randomized controlled trial (the Hip Fracture Evaluation with Alternatives of Total Hip Arthroplasty versus Hemi-Arthroplasty (HEALTH) study). We asked surgeons their current preferences for the management of displaced femoral neck fractures and whether a trial that definitively revealed a substantial improvement in function and quality of life with no difference in risk of revision surgery was important and would cause them to change practice.
Of 883 surgeons surveyed, 210 responded from IHFRC and 586 from AO/ASIF (a response rate of 90%). Most surgeons (61%) preferred hemiarthroplasty (HA) for treating displaced femoral neck fractures. 72% of responding surgeons believed that a substantial improvement in patient function with total hip arthroplasty (THA) and no adverse effects on revision surgery would be an important finding. Moreover, of 483 surgeons who preferred hemiarthroplasty, 62% would change their practice based upon the findings of the trial.
Large clinical trials in orthopedics are worthwhile endeavors, as they have the potential to change practice among surgeons. Surgeons seem willing to adopt alternative surgical approaches if the evidence is compelling and sound.
PMCID: PMC2856216  PMID: 20146638
6.  Global burden of trauma: Need for effective fracture therapies 
Indian Journal of Orthopaedics  2009;43(2):111-116.
Orthopedic trauma care and fracture management have advanced significantly over the last 50 years. New developments in the biology and biomechanics of the musculoskeletal system, fixation devices, and soft tissue management have greatly influenced our ability to care for musculoskeletal injuries. Many therapies and treatment modalities have the potential to transform future orthopedic treatment by decreasing invasive procedures and providing shorter healing times. Promising results in experimental models have led to an increase in clinical application of these therapies in human subjects. However, for many modalities, precise clinical indications, timing, dosage, and mode of action still need to be clearly defined. In order to further develop fracture management strategies, predict outcomes and improve clinical application of newer technologies, further research studies are needed. Together with evolving new therapies, the strategies to improve fracture care should focus on cost effectiveness. This is a great opportunity for the global orthopedic community, in association with other stakeholders, to address the many barriers to the delivery of safe, timely, and effective care for patients with musculoskeletal injuries in developing countries.
PMCID: PMC2762254  PMID: 19838358
Trauma; fracture; bone stimulation therapies; orthopedic community
7.  Electrical stimulation: Nonunions 
Indian Journal of Orthopaedics  2009;43(2):149-155.
The current paper attempts to provide an overview on the currently available fundamental, preclinical, and clinical evidence on the biologic rationale and therapeutic efficacy of electrical stimulation devices applied in patients with long-bone nonunions. Electrical stimulation (ES) involves the generation of an electrical or electromagnetic current through the ununited fracture. Such currents, which are present in physiologically healing bone, provide stimuli that favor a healing response to bone cells. These stimuli include the enhancement of transmembrane and intracellular calcium-mediated signal transduction and an increased synthesis of paracrine and autocrine growth factors by osteoblasts. Favorable healing union rates, ranging from 43% to 90%, as found by several clinical case series, have prompted the orthopedic community to, at least partially, adopt ES for the treatment of long bone nonunions. Nonetheless, randomized controlled trials have not provided definitive evidence of ES causing nonunions to heal more often than sham devices. This impediment is probably formed by small sample sizes, lack of consistency regarding the definition of union and nonunion, and variability in ES current used.
PMCID: PMC2762246  PMID: 19838363
Electric stimulation; fractures; nonunions
8.  Surgeons' beliefs and perceptions about removal of orthopaedic implants 
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.
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.
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).
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.
PMCID: PMC2430567  PMID: 18501014
9.  What is a clinical decision analysis study? 
Indian Journal of Orthopaedics  2008;42(2):137-139.
Decision making in clinical practice often involves the need to make complex and intricate decisions with important long-term consequences. Decision analysis is a tool that allows users to apply evidence-based medicine to make informed and objective clinical decisions when faced with complex situations. A Decision Tree, together with literature-derived probabilities and defined outcome values, is used to model a given problem and help determine the best course of action. Sensitivity analysis allows an exploration of important variables on final clinical outcomes. A decision-maker can thereafter establish a preferred method of treatment and explore variables which influence the final outcome. The present paper is intended to give an overview of decision analysis and its application in clinical decision making.
PMCID: PMC2759613  PMID: 19826517
Clinical trials; critical appraisal; decision analysis; evidence-based medicine; hierarchy of evidence
10.  Fluid lavage in patients with open fracture wounds (FLOW): an international survey of 984 surgeons 
Although surgeons acknowledge the importance of irrigating open fracture wounds, the choice of irrigating fluid and delivery pressure remains controversial. Our objective was to clarify current opinion with regard to the irrigation of open fracture wounds.
We used a cross-sectional survey and a sample-to-redundancy strategy to examine surgeons' preferences in the initial management of open fracture wounds. We mailed this survey to members of the Canadian Orthopaedic Association and delivered it to attendees of an international fracture course (AO, Davos, Switzerland).
Of the 1,764 surgeons who received the questionnaire, 984 (55.8%) responded. In the management of open wounds, the majority of surgeons surveyed, 676 (70.5%), favoured normal saline alone. Bacitracin solution was used routinely by only 161 surgeons (16.8%). The majority of surgeons, 695 (71%) used low pressures when delivering the irrigating solution to the wound. There was, however considerable variation in what pressures constituted high versus low pressure lavage. The overwhelming majority of surgeons, 889 (94.2%), reported they would change their practice if a large randomized controlled trial showed a clear benefit of an irrigating solution – especially if it was different from the solution they used.
The majority of surgeons favour both normal saline and low pressure lavage for the initial management of open fracture wounds. However, opinions varied as regards the comparative efficacy of different solutions, the use of additives and high versus low pressure. Surgeons have expressed considerable support for a trial evaluating both irrigating solutions and pressures.
PMCID: PMC2259344  PMID: 18215287
11.  Conducting a clinical study: A guide for good research practice 
Indian Journal of Orthopaedics  2007;41(1):27-31.
PMCID: PMC2981890  PMID: 21124679
12.  Clinical studies in spinal surgery 
European Spine Journal  2005;14(8):721-725.
There is a growing interest in applying evidence-based approaches also in orthopedic surgery. Despite many challenges to the validity of clinical trials in orthopedic surgery, it is possible to conduct well-designed trials in this field and to produce clinically important findings and reasonably valid conclusions about effectiveness, prognosis and diagnosis in orthopedic surgery. We describe the main principles for conducting clinical trials in this field as well as some of the most common errors and ways to avoid them.
PMCID: PMC3489255  PMID: 15940476
Surgical treatment; Spine surgery; Clinical trial design; Bias; Confounding
13.  Pathways to evidence-based knowledge in orthopaedic surgery: an international survey of AO course participants 
International Orthopaedics  2005;29(1):59-64.
The aim of this study was to gain information about how orthopaedic surgeons use evidence-based literature and how this is influenced by their knowledge of evidence-based medicine. We administered a questionnaire to participants at courses of the Association for the Study of Internal Fixation (AO-ASIF) in Davos, Switzerland, in December 2003. Special attention was paid to the surgeons’ educational level, affiliations, and the infrastructure and evidence sources they used. In addition, we tested participants on their knowledge and attitude to evidence-based orthopaedic surgery (EBOS). Of 1,274 course participants, 456 completed the questionnaire. Of 446 respondents, 300 had heard of EBOS, but only 45% could define it correctly. Nearly two thirds identified scientific publications as their main source of scientific knowledge. The respondents’ attitudes to and awareness of EBOS principles was high, but it did not influence their manner of searching for scientific information or their trust in various sources of recommendations.
PMCID: PMC3456943  PMID: 15647916
14.  Psychological distress and quality of life after orthopedic trauma: an observational study 
Canadian Journal of Surgery  2008;51(1):15-22.
Little is known about the clinical consequences of psychological morbidity associated with orthopedic trauma. The objective of our study was to investigate the extent of psychological symptoms that patients experience following orthopedic trauma and whether these are associated with quality of life.
All patients attending 10 orthopedic fracture clinics at 3 university-affiliated hospitals between January and October 2003 were screened for study eligibility. Eligible patients were aged 16 years or older, were English-speaking, were being followed actively for a fracture(s), were cognitively able to complete the questionnaires and provided informed consent. All consenting patients completed a baseline assessment form, the Symptom Checklist-90-Revised and a health-related quality of life questionnaire (the Medical Outcomes Study 36-item Short Form [SF-36]). We conducted regression analyses to determine predictors of quality of life among study patients.
Of the patients, 250 were eligible, and 215 agreed to participate; 59% were men; the patients' mean age was 44.5 (standard deviation [SD] 18.8) years. Over one-half (54%) of the patients had lower extremity fractures. Patient Physical Component summary scores were associated with older age (β = –0.28, p < 0.001), ongoing litigation (β = –0.18, p = 0.02), fracture location (β = –0.18, p = 0.01) and Positive Symptom Distress Index (i.e., the intensity of psychological symptoms; β = –0.08, p = 0.003). This model predicted 21% of the variance in patients' Physical Component summary scores. Somatization was an important psychological symptom negatively associated with Physical Component summary scores. Reduced Mental Component summary scores were associated with ongoing litigation (β = –0.18, p = 0.03) and Global Severity Index of psychological symptoms (β = –0.50, p < 0.001). This model explained 31% of the variability in patients' Mental Component summary scores.
In a prospective study of 215 patients, 1 in 5 met the threshold for psychological distress. Only ongoing litigation and psychological symptoms were significantly associated with both SF-36 Physical Component and Mental Component summary scores. Future research is necessary to determine whether orthopedic trauma patients would benefit from early screening and intervention to address comorbid psychopathology.
PMCID: PMC2386305  PMID: 18248701

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