Bauke W Kooistra

The radiographic union scale in tibial fractures: reliability and validity.

Radiographic assessment of tibial fracture healing continues to pose significant challenges to both routine fracture care and clinical research. Orthopaedic surgeons fail to achieve sufficient agreement on fracture healing when using conventional radiographic measures such as their general impression or the number of cortices bridged by callus. Moreover, the extent to which radiographic assessment of healing corresponds to patient-important outcomes is largely unknown. In an attempt to improve the former (ie, reliability) and inform the latter (ie, validity), recent studies have explored a novel radiographic assessment for tibial shaft fractures, the Radiographic Union Scale for Tibial fractures (RUST). The RUST score assesses the presence of bridging callus and that of a fracture line on each of 4 cortices seen on 2 orthogonal radiographic views. A recent study has found that RUST scores have greater inter-rater reliability when compared with surgeons general impression or the number of cortices bridged by callus. This may increase the utility of radiographs as a standardized measure of treatment efficacy in the follow-up of tibial fractures.

How to Design a Good Case Series

A case series is a descriptive study that follows a group of patients who have a similar diagnosis or who are undergoing the same procedure over a certain period of time. As there is no experimental protocol or control for allocation of patients to treatment, surgeons and patients decide on whether or not treatment is given, making the clinical sample representative of a common clinical population. Results of case series can generate hypotheses that are useful in designing further studies, including randomized controlled trials. However, no causal inferences should be made from case series regarding the efficacy of the investigated treatment. This article will provide principles for the design, analysis, and reporting of case series, illustrated by examples from the orthopaedic surgical literature.

Twenty Years of Meta-Analyses in Orthopaedic Surgery: Has Quality Kept Up with Quantity?

BACKGROUND As the number of studies in the literature is increasing, orthopaedic surgeons highly depend on meta-analyses as their primary source of scientific evidence. The objectives of this review were to assess the scientific quality and number of published meta-analyses on orthopaedics-related topics over time. METHODS We conducted, in duplicate and independently, a systematic review of published meta-analyses in orthopaedics in the years 2005 and 2008 and compared them with a previous systematic review of meta-analyses from 1969 to 1999. A search of electronic databases (MEDLINE, EMBASE, and the Cochrane Database of Systematic Reviews) was performed to identify meta-analyses published in 2005 and 2008. We searched bibliographies and contacted content experts to identify additional relevant studies. Two investigators independently assessed the quality of the studies, using the Oxman and Guyatt index, and abstracted relevant data. RESULTS We included forty-five and forty-four meta-analyses from 2005 and 2008, respectively. While the number of meta-analyses increased fivefold from 1999 to 2008, the mean quality score did not change significantly over time (p = 0.067). In the later years, a significantly lower proportion of meta-analyses had methodological flaws (56% in 2005 and 68% in 2008) compared with meta-analyses published prior to 2000 (88%) (p = 0.006). In 2005 and 2008, respectively, 18% and 30% of the meta-analyses had major to extensive flaws in their methodology. Studies from 2008 with positive conclusions used and described appropriate criteria for the validity assessment less often than did those with negative results. The use of random-effects and fixed-effects models as pooling methods became more popular toward 2008. CONCLUSIONS Although the methodological quality of orthopaedic meta-analyses has increased in the past twenty years, a substantial proportion continues to show major to extensive flaws. As the number of published meta-analyses is increasing, a routine checklist for scientific quality should be used in the peer-review process to ensure methodological standards for publication.

Outcomes assessment in fracture healing trials: a primer.

The measurement of clinical outcomes in trauma research is often problematic in that it is subjective and currently no feasible gold standard evaluation is available. Consequently, observed trial results are partly dependent on which outcome measure is used. Precise and useful estimates of treatment effects can only be obtained when using reliable, valid, and responsive instruments for measuring fracture healing. This overview outlines the concept of the validation of outcome measures and provides a summary of available and frequently used instruments in orthopaedic clinical trials. Outcome instruments can be divided into assessments by the clinician and assessments by the patient. Clinician-assessed measures are frequently used in routine practice but have often not been validated before their use in research. They include clinical and radiographic assessments. In contrast, patient-assessed measures have been designed specifically for investigational purposes and measure health on various domains. Some of them have been validated extensively. Critically evaluating established clinician-based assessments and integrating those found to be valid with patient-assessed outcomes into a composite measure of fracture healing constitute major future challenges.

Electrical stimulation: nonunions.

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.

Prospectively screening for eligible patients was inaccurate in predicting patient recruitment of orthopedic randomized trials

OBJECTIVE To compare the accuracy of estimates of potential recruitment from a prospective 8-week screening study compared with a retrospective chart review across sites participating in two fracture management trials. STUDY DESIGN AND SETTING During the planning phase of two large, multicenter, randomized controlled fracture management trials, 74 clinical sites provided estimates of the annual recruitment rate both retrospectively (based on chart reviews) and prospectively. The prospective estimate was generated by screening, for 8 weeks, all incoming patients for eligibility in the concerning trial, without actually enrolling any patient. We compared these prospective and retrospective estimates with one another (for 74 sites in the two trials) and with actual 1-year recruitment rates in the definitive trial (for nine sites in one trial). RESULTS There was a median difference of four patients (interquartile range: -14 to 18 patients; P=0.89) between a centers prospective estimate and its retrospective estimate. Both predictions were overestimations of recruitment in the definitive trial; only 31% (95% confidence interval [CI]: 28, 35) of retrospectively estimated patients, and 31% (95% CI: 27, 35) of prospectively estimated patients were recruited in the definitive trials. CONCLUSION Compared with relatively simple chart reviews, prospectively screening for eligible patients at clinical sites, which is associated with substantial costs, did not result in more accurate predictions of accrual in large, multicenter, randomized controlled trials.

Decision making open reduction/internal fixation versus arthroplasty for femoral neck fractures

Summary: Femoral neck fractures account for half of all hip fractures with a rapidly increasing incidence. Since they are associated with high mortality, decrease in quality of life, and high total costs, much research on the optimal treatment of these fractures has been undertaken. In this article, we provide a summary of the available evidence comparing open reduction and internal fixation and arthroplasty. We focus on the treatment of displaced femoral neck fractures in active, healthy elderly patients. Additionally, we discuss treatment options for patients with undisplaced femoral neck fractures, younger patients, and patients with cognitive impairments. Furthermore, we present cost-effectiveness analyses on the treatment of these fractures, comparing both costs and patient benefits between internal fixation and different arthroplasty approaches.