Beate Hanson

Functional outcomes after nonoperative management of fractures of the proximal humerus.

BACKGROUND Prospective follow-up data after nonoperative treatment for fractures of the proximal humerus are scarce. We studied functional outcomes and rates of complication and failure after conservative management of these common injuries. MATERIALS AND METHODS Consecutive patients aged older than 18 years presenting to the emergency department of a large district hospital with an isolated, closed proximal humeral fracture considered suitable for functional treatment by the surgeon on charge were enrolled in a prospective, externally monitored observational study. Surgeons were free to reduce the fracture and to prescribe any type of sling or brace. Active follow-up after 12 weeks, 6, and 12 months included plain radiographs, Constant score, and Disabilities of Arm, Shoulder and Hand (DASH) score. RESULTS We enrolled 160 patients (118 women; mean age, 63.3 +/- 14.8 years), and 124 completed 1-year follow-up. There were 85, 71, and 4 AO 11 A, B, and C fractures, and 75 one-part, 60 two-part, 23 three-part, and 2 four-part and head-splitting fractures. After 1 year, the mean difference in Constant scores between the injured and contralateral shoulder was 8.2 (95% confidence interval [CI], 6.0-10.4). The mean difference in 1-year DASH scores to baseline assessment was 10.2 points (95% CI 7.3-13.1 points). The risk of delayed and nonunion was 7.0% (95% CI, 3.6%-12.3%). Four patients subsequently underwent surgical fixation, and 5 had arthroscopic subacromial decompression. CONCLUSION This study may provide reference values for future investigations and stresses ceiling effects that will make it difficult to demonstrate a significant advantage of surgical over nonoperative treatment in patients with proximal humeral fractures. LEVEL OF EVIDENCE Level 4; Prospective case series without a control group.

A concept for the validation of fracture classifications.

The fracture classification systems currently used most frequently were not developed or validated by rigorous scientific evaluation methods. This paper discusses the classification of fractures from an epidemiological and clinical decision-making perspective and proposes a standardized methodological concept for their development and scientific validation. Classification categories are clinically relevant entities that surgeons should be able to use for diagnosis with sufficient confidence to limit misclassification and associated treatment errors. The process of validation should assess the value of specific clinical information (eg, the use of radiographs or computed tomography scans) in increasing the probability of a correct diagnosis. A 3-phase validation concept is proposed where: 1) classification categories are defined and the classification process using specific diagnostic images is evaluated by experts in a series of agreement studies (reliability, accuracy, likelihood ratios); 2) a multicenter agreement study is conducted among a representative group of future users of the classification; and 3) the classification proposal is applied in the context of a prospective clinical study to assess its clinical usefulness.

Surgeons' Preferences for the Operative Treatment of Fractures of the Tibial Shaft: An International Survey

There are more potential treatments for tibial fractures and more potential complications of those treatments than there are for any other type of fracture. The American Academy of Orthopaedic Surgeons recently reviewed malpractice claims to identify the procedures and diagnoses that have most commonly resulted in legal action. Among all orthopaedic conditions, fractures of the tibia and fibula ranked second with regard to the total number of patient malpractice claims, accounting for over thirty million dollars in indemnity1. The National Center for Health Statistics reported that more than 490,000 fractures of the tibia and fibula occur each year in the United States2. Although many tibial fractures may be managed nonoperatively, fractures for which nonoperative treatment has failed, open fractures, fractures with an associated compartment syndrome, and high-energy fractures require operative stabilization3. Surgical options include external fixation, plate fixation, and intramedullary nailing with or without reaming. Although there is a consensus among orthopaedic surgeons with regard to the optimal treatment of fractures of the femoral shaft, the appropriate treatment of closed and open tibial fractures remains controversial. Meta-analyses that include randomized trials provide the best evidence regarding the results of operative treatment of fractures of the tibial shaft4-7. In our meta-analysis6, one randomized trial8, involving fifty-six patients, showed a significant reduction in the rate of reoperation after external fixation compared with the rate after the use of plates (relative risk reduction, 87%; 95% confidence interval, 46% to 97%). Other trials showed that nailing without reaming resulted in a significant reduction in the risk of reoperation compared with the risk after external fixation (relative risk reduction, 49%; 95% confidence interval, 31% to 63%). Nailing with reaming reduced the risk of nonunion of closed and open fractures of the …

Health-related quality of life following operative treatment of unstable ankle fractures: A prospective observational study

Background: Although Weber type B ankle fractures are often considered benign with a good prognosis, evidence from observational studies suggests that 17% to 24% of such patients may have less satisfactory outcomes. Although the explanation for variability in outcomes remains unclear, previous studies of other surgical procedures have suggested nonsurgery-related causes account for much of the variability in outcomes. Methods: We conducted a prospective observational cohort study to evaluate health-related quality of life in 30 patients with unstable ankle fractures who were otherwise healthy. Only patients from 2 university-affiliated hospitals sustaining unstable type B Weber injury patterns requiring surgery were eligible. Patients provided detailed baseline information regarding alcohol consumption, smoking habits, and educational level. Patients completed the short form 36 questionnaire and a visual analogue pain scale at regular follow-up intervals. Results: The average patient age was 51.6 years (SD 15.2 years), and 57% (17 out of 30) were male. The majority of fractures were the result of a fall (67%, 20 out of 30), and all were closed injuries. Almost half of all patients were smokers (47%, 14 out of 30), whereas 43% consumed alcohol on a weekly basis (13 out of 30). Forty-three percent of patients (13 out of 30) had obtained an elementary or high school level of education. Patients experienced significant improvements in all domains of the SF-36 questionnaire (P < 0.001), except general health, which remained essentially normal over the 24-month period. Study patients achieved scores similar to age-matched U.S. normative data across 6 of the 8 domains (Role Emotional, Social Function, Mental Health, Bodily Pain, Vitality, and General Health). However, patients’ physical function and role physical scores remained significantly lower than US norms at 24 months (21.8 and 20.7 points lower on a 100-point scale, respectively; P < 0.001). Smoking history (P = 0.02), presence of a medial malleolar fracture (P = 0.02), and lower levels of education (P = 0.01) were significant independent predictors of lower physical function up to 3 months postoperation. Lower mental health domain scores were significantly associated with alcohol use (P = 0.02) and increasing age (P = 0.04). Conclusions: As is the case in many other areas, social factors may be important determinants of outcome in patients with traumatic fractures. Optimal orthopedic care may involve attention to modifiable risk factors, including smoking and alcohol consumption.

Optimal internal fixation for femoral neck fractures: multiple screws or sliding hip screws?

Introduction: The number of hip fractures is likely to exceed 500,000 in the United States and 88,000 in Canada annually over the next 40 years. Hip fractures are associated with a 30% mortality rate at 1 year and profound temporary, and sometimes permanent, impairment of independence and quality of life. Objectives: Although much focus has centered around the comparison of arthroplasty versus internal fixation devices in the treatment of femoral neck fractures, the optimal approach for internal fixation has been largely ignored. Identifying the optimal technique for internal fixation could reduce the historically high rates of revision surgery that have fueled arguments against fixing patients with displaced femoral neck fractures. Results: Both indirect and direct comparisons suggest a possible benefit for a sliding hip screw over multiple cancellous screws in reducing the need for revision surgery. The indirect nature of the comparison from the meta-analysis of arthroplasty versus internal fixation, and the small sample sizes, methodological limitations, and nonsignificant pooled estimate from the direct comparisons, leaves the issue very much in doubt. Conclusions: Although the rationale for arthroplasty continues to gain popularity, previous studies suggest that we have yet to identify the best approach for internal fixation. Previous trials suggest that the issue is largely unresolved and solutions will likely come from larger randomized trials comparing alternative devices for fixing the hip.

Clinical evaluation of medicinal products for acceleration of fracture healing in patients with osteoporosis.

Pre-clinical studies indicate that pharmacologic agents can augment fracture union. If these pharmacologic approaches could be translated into clinical benefit and offered to patients with osteoporosis or patients with other risks for impaired fracture union (e.g. in subjects with large defects or open fractures with high complication rate), they could provide an important adjunct to the treatment of fractures. However, widely accepted guidelines are important to encourage the conduct of studies to evaluate bioactive substances, drugs, and new agents that may promote fracture union and subsequent return to normal function. A consensus process was initiated to provide recommendations for the clinical evaluation of potential therapies to augment fracture repair in patients with meta- and diaphyseal fractures. Based on the characteristics of fracture healing and fixation, the following study objectives of a clinical study may be appropriate: a) acceleration of fracture union, b) acceleration of return to normal function and c) reduction of fracture healing complications. The intended goal(s) should determine subsequent study methodology. While an acceleration of return to normal function or a reduction of fracture healing complications in and of themselves may be sufficient primary study endpoints for a phase 3 pivotal study, acceleration of fracture union alone is not. Radiographic evaluation may either occur at multiple time points during the healing process with the aim of measuring the time taken to reach a defined status (e.g. cortical bridging of three cortices or disappearance of fracture lines), or could be obtained at a single pre-determined timepoint, were patients are expected to reach a common clinical milestone (i.e. pain free full weight-bearing in weight-bearing fracture cases). Validated Patient Reported Outcomes (PROs) measures will need to support the return to normal function co-primary endpoints. If reduction of complication rate (e.g. non-union) is the primary objective, the anticipated complications must be defined in the study protocol, along with their possible associations with the specified fracture type and fixation device. The study design should be randomized, parallel, double-blind, and placebo-controlled, and all fracture subjects should receive a standardized method of fracture fixation, defined as Standard of Care.

What should an ideal spinal injury classification system consist of? A methodological review and conceptual proposal for future classifications.

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.

Operative treatment of extra-articular proximal tibial fractures.

Background Extra-articular proximal tibial fractures are often the result of high-energy trauma with displacement and comminution. Most authors agree that operative management of these fractures is warranted to optimize patient outcomes. It is unclear, however, which surgical option (plate, nail, external fixator, or combination) is preferable. 1–17 Objective To evaluate the effect of alternative operative techniques in the management of extra-articular proximal third tibial fractures on rates of nonunion, malunion, infection, compartment syndrome, and implant failure. Highest Available Evidence 1. Intramedullary nail (level 3 prospective case series) 2. Plates (level 3 prospective case series) 3. External fixator (level 4 case series) Study Identification 1. Cochrane Database: 0 articles 2. PubMed Search: Proximal tibial fractures: 568 hits; And external fixation: 69 hits; And plate: 103 hits; And intramedullary nail: 77 hits Clinical queries search: proximal tibial fracture (specificity/therapy): 1 hit; proximal tibial fracture (sensitivity): 24 hits Systematic reviews: 3 hits (none relevant) 3. OTA website abstract database: 8 abstracts Total number potentially relevant articles: 29 (following review of all study titles and abstracts) Total number included after review: 17 (1–17)

Complication Reporting in Orthopaedic Trials

BACKGROUND The nature and frequency of complications during or after orthopaedic interventions represent critical clinical information for safety evaluations, which are required for the development or improvement of orthopaedic care. The goal of this systematic review was to check whether essential data regarding the assessment of the prevalence, severity, and characteristics of complications related to orthopaedic interventions are consistently provided by the authors of papers on randomized controlled trials. METHODS Five major peer-reviewed orthopaedic journals were screened for randomized controlled trials published between January 2006 and July 2007. All relevant papers were obtained, anonymized, and evaluated by two external reviewers. A checklist consisting of three main parts (definition, evaluation, and reporting) was developed and applied for the assessment of complication reporting. The results were stratified into surgical and nonsurgical categories. RESULTS One hundred and twelve randomized controlled trials were identified. Although complications were included as trial outcomes in two-thirds of the studies, clear definitions of anticipated complications were provided in only eight trials. In 83% of the trials, the person or group assessing the complications was not identified. No trial involved a data safety review board for assessment and classification of complications. CONCLUSIONS The lack of homogeneity among the published studies that we reviewed indicates that improvement in the reporting of complications in orthopaedic clinical trials is necessary. A standardized protocol for assessing and reporting complications should be developed and endorsed by professional organizations and, most importantly, by clinical investigators.

Perception of Garden's classification for femoral neck fractures: an international survey of 298 orthopaedic trauma surgeons

The Garden classification is the most popular femoral neck fracture classification system. We surveyed orthopaedic surgeons about their preferences for femoral neck fracture classification systems and their belief about their ability to discriminate between the four different Garden fracture types. A questionnaire was developed to examine surgeons’ training and experience and their preferences for classification of femoral neck fractures by consulting five orthopaedic surgeons in Canada and the United States, and the previous literature. The Garden classification was the preferred femoral neck fracture classification for 72% of all the surveyed surgeons (n=298). Only 39% of all the surveyed surgeons believed they were able to distinguish all four Garden fracture types. However, 96% of the surgeons felt they could differentiate between undisplaced (Garden I/II) and displaced (Garden III/IV) fractures. High variability in the surgeons’ perceptions of the Garden classification system provides a rationale for discontinuing the use of this system in daily practice.