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Emergency Radiology |
1 From the Program for the Assessment of Radiological Technology (ART Program) (E.H.G.O., J.J.N., M.G.M.H.) and Departments of Radiology (E.H.G.O., J.J.N., A.Z.G., G.P.K., M.G.M.H.), Epidemiology and Biostatistics (E.H.G.O., J.J.N., M.G.M.H.), Orthopaedic Surgery (J.A.N.V.), and Traumatology (A.B.v.V.), Erasmus MC, University Medical Center Rotterdam, Room EE21-40a, Dr Molewaterplein 50, 3015 GE Rotterdam, the Netherlands. Received July 7, 2003; revision requested September 24; revision received April 5, 2004; accepted May 19. Supported in part by the Revolving Fund of the University Hospital Rotterdam and by Esaote, Genoa, Italy. Address correspondence to M.G.M.H. (e-mail: m.hunink@erasmusmc.nl).
| ABSTRACT |
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MATERIALS AND METHODS: The randomized controlled trial and use of collected data for prediction modeling were approved by the institutional review board; informed consent was obtained. Patients with recent knee injury were included in the trial if radiography was ordered. They were randomized into a group undergoing only radiography and a group undergoing radiography plus immediate MR imaging. A 0.2-T dedicated extremity MR imager and four short pulse sequences were used. Univariable and multivariable logistic regression analysis was used to evaluate patient characteristics, trauma mechanism, and findings at radiography and MR imaging for their value in prediction of need for subsequent treatment within the 6-month follow-up.
RESULTS: Data in 189 patients (123 male patients, 66 female patients; mean age, 33.4 years), 109 of whom underwent treatment after their initial visit, were analyzed. Age of 30 years or older, indirect trauma mechanism, radiographic results, and MR imaging results were significant predictors of need for treatment in univariable and multivariable analyses (P < .05). In the multivariable analysis, only abnormal MR imaging results were significantly predictive of need for treatment, and only when MR imaging replaced radiography (odds ratio, 2.61; 95% confidence interval: 1.12, 6.06).
CONCLUSION: Implementation of a dedicated extremity MR imaging examination, in addition to or instead of radiography, performed in patients with traumatic knee injury improves prediction of the need for additional treatment but does not significantly aid in identification of patients who can be discharged without further follow-up. Value of a short MR imaging examination in the initial stage after knee trauma is limited.
© RSNA, 2005
| INTRODUCTION |
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If a fracture is suspected, radiography usually is added to the diagnostic work-up, and such an addition often is based on criteria previously published as the Ottawa Knee Rule (9,10). Traumatic abnormalities, other than a fracture, that cannot be visualized by using radiography may be present in the knee joint. Unlike radiography, magnetic resonance (MR) imaging provides information on soft-tissue damage and has been accepted widely for the evaluation of internal knee derangements. A recent systematic review and meta-analysis demonstrated that MR imaging has a very good performance in diagnosis of tears of the menisci and cruciate ligaments (11). Nonetheless, the routine use of MR imaging in the initial work-up of acute knee injuries has been hampered by the high costs, the limited availability, and the long duration of an MR imaging examination. Low-field-strength dedicated extremity MR imagers have been developed to overcome some of these problems. Because of the compact design and low field strength of these types of imagers, the costs can be kept relatively low compared with the costs of high-field-strength whole-body units. Therefore, low-field-strength dedicated extremity MR imaging has created the possibility to apply MR imaging more routinely in the initial evaluation of knee trauma.
Application of MR imaging as an initial examination tool after knee trauma in the emergency department setting can potentially yield benefit to the patient and the health care system. Detailed imaging information in an early stage may result in more timely diagnosis and treatment in patients who would otherwise have been followed up, with delay of definitive therapy. Conversely, patients could possibly be identified who are unlikely to require specific treatment and who will thus not need reassessment or follow-up. In the light of cost minimization and efficiency, this identification would be beneficial, since these patients do not need to return to the outpatient department.
The purpose of this study was to assess the predictive value of a short MR imaging examination, in addition to or instead of radiography, performed in patients who present with acute knee trauma to identify those who require additional treatment versus those who do not and can be discharged without further follow-up.
| MATERIALS AND METHODS |
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From August 1999 to May 2001, we recruited patients from the emergency department of our university hospital who were referred for radiography by a traumatologist, orthopedic surgeon, or emergency physician because of traumatic knee injury within the preceding 7 days. We excluded patients who had additional injuries of the head, back, thorax, or abdomen; patients with a compound knee fracture; patients requiring urgent treatment (eg, in case of a threat to the circulation of the leg); and patients with preexisting symptoms in the same knee. Patients were included 7 days per week from 8:00 AM to 11:00 PM. All eligible patients were provided with written and oral information about the aim of the study. After informed consent was obtained, patients were randomized to a group who would undergo the current diagnostic work-up (only radiography) and a group who would undergo radiography and a short dedicated extremity MR imaging examination immediately afterward. Randomization was performed by research staff who were not involved in the further treatment of the patient with use of consecutively numbered sealed envelopes containing computer-generated random assignments. We applied block randomization with a block size of 20 patients to achieve equal numbers of patients in both study arms.
Imaging
Radiography was performed in the anteroposterior and lateral views. In a few patients, additional patellar or tunnel views were obtained because a patellar fracture or a loose body was suspected by the examining physician. For the MR imaging examination, we used a low-field-strength dedicated extremity MR imaging system (Artoscan M; Esaote Biomedica, Genoa, Italy) with a 0.2-T permanent magnet and a dual phased-array knee coil. A larger linear knee coil was used in patients with a very large knee. In regard to the imaging protocol, we aimed at providing a quick examination in the emergency setting that would minimize the costs and burden to the patient. With these goals in mind, we adapted several imaging parameters to reduce total examination time. This adaptation resulted in some loss of image quality, but in a pilot study, the imaging protocol as described in Table 1 was found to be of acceptable quality for the detection of most lesions (14). Average total acquisition time was 6 minutes 7 seconds, with a total examination time, including start-up of the MR imaging unit and patient positioning, of shorter than 15 minutes.
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For the purpose of our analysis, the results of radiography and MR imaging were interpreted as abnormal or normal on the basis of the presence or absence of recent traumatic abnormalities that required treatment. Results of radiography were considered abnormal if a fracture, an epiphysiolysis, a dislocation, or an osteochondral lesion was visible. Results of MR imaging were interpreted as abnormal if one or more of the following were present: a fracture, an epiphysiolysis, a dislocation, an osteochondral lesion, a meniscal tear, a total rupture of the anterior cruciate ligament, a total rupture of the posterior cruciate ligament, a total or partial rupture of the medial collateral ligament, or a total or partial rupture of the lateral collateral ligament. Although a partial rupture of the anterior or the posterior cruciate ligament is obviously a traumatic lesion, we considered the MR imaging results as normal, for the purpose of our analysis, if this was the only visible abnormality, since an isolated partial tear of a cruciate ligament does not usually need specific treatment. A partial rupture of the collateral ligament, however, usually is treated with a knee brace. Similarly, results of radiography and MR imaging were interpreted as normal (ie, not requiring specific treatment) if only joint effusion, hemarthrosis, soft-tissue edema, bone marrow edema, meniscal degeneration, or osteoarthritis was seen or if the findings suggested an old traumatic lesion. Bone marrow edema does not require specific treatment, but it may be suggestive of an intraarticular lesion, and therefore its presence may increase the likelihood of treatment. Therefore, we reanalyzed the data with isolated bone marrow edema interpreted as an MR imaging finding that required treatment.
Follow-up and Outcome
The outcome measure was additional treatment within 6 months after the initial visit to the emergency department. Treatment was defined as any specific additional therapy, which included surgery, physical therapy with supervised and structured rehabilitation exercises, a plaster cast, and taping.
Patients were followed up as long as they had daily complaints of the affected knee, and this follow-up time was as long as a maximum of 6 months after initial presentation. Data were collected by searching the emergency department records, hospital records, outpatient clinic records, and electronic hospital information system. In addition, we sent questionnaires to all patients, and the questionnaires included questions about whether they had undergone treatment at another institution. These questionnaires were mailed at 1, 6, and 12 weeks and at 6 months after the initial visit to the emergency department. If the questionnaires were not returned, we attempted to interview the patients by telephone. Patient records were reviewed, and patients were interviewed by two of the authors (E.H.G.O. and J.J.N.) and research support staff. The final diagnosis was determined by reviewing all information from diagnostic imaging, follow-up, questionnaires, or arthroscopy or surgery reports, if available.
Since one may argue that the indications for physical therapy often are not well defined, we performed a separate analysis in which physical therapy was not considered a specific treatment.
Statistical Analysis
The data were analyzed according to intention to diagnose and treat by using univariable and multivariable logistic regression analysis. We evaluated the following independent variables for their statistical significance in the prediction of whether treatment was required within 6 months after the initial hospital visit: age (both continuous and dichotomous at various threshold levels), sex, side of trauma, trauma mechanism (indirect or direct trauma), and the results of both radiography and MR imaging (abnormality that required treatment vs no abnormality). The absence of MR imaging information, which was the case in half of our patient population because of the randomized study design, was used as the reference category for the MR imaging results in the analysis (normal or abnormal vs no MR imaging information). This allowed us to determine the additional value of the MR imaging results compared with no MR imaging information.
To account for the fact that the findings at radiography and MR imaging were correlated, we created what we called an overall imaging variable, in which the results of both the radiographic and MR imaging examinations were integrated. In this variable, the following five possible combinations of radiographic and MR imaging results were coded by using four dummy variables: (a) normal radiographic results and no MR imaging information (reference category), (b) normal results of both radiography and MR imaging, (c) abnormal results of radiography and no MR imaging information, (d) discrepant results of radiography and MR imaging, and (e) abnormal results of both radiography and MR imaging. By using the overall imaging variable, one takes into account the diagnostic interaction between radiography and MR imaging results, which may be involved if two imaging modalities are used together to visualize the same lesion. It is, therefore, a more appropriate manner of analyzing the results of radiography and MR imaging combined, rather than using the two variables separately, in the same regression model.
We first assessed each variable separately with univariable logistic regression analysis and calculated the odds ratio and the 95% confidence interval. Subsequently, we performed multivariable logistic regression analyses, which included all variables that had a P value of less than .10 (
2 test) in the univariable analysis. Because we wanted to assess the value of the imaging modalities, we created four models that included the following: radiographic results (model 1), MR imaging results (model 2), radiographic and MR imaging results (model 3), and the overall imaging variable described previously (model 4). We used the Hosmer-Lemeshow goodness-of-fit test to evaluate the calibration of the models. A Hosmer-Lemeshow goodness-of-fit test result that was not significant (P > .05) indicated that the model fit well with the observed data (15). The area under the receiver operating characteristic curve was calculated to assess the discriminatory power of each model in distinguishing patients who required treatment from those who could be discharged. A larger area under the receiver operating characteristic curve indicated a higher discriminatory power (16).
To compare the area under the receiver operating characteristic curve across the models, we used the method described by Hanley and McNeil (17), which provides adjustment for the fact that the models were correlated since they were derived from the same sample of patients. The likelihood ratio test, which can be used for comparing nested models, was used to assess the value of MR imaging in addition to radiography with a comparison of models 1 and 3. To compare models that are not nested, one needs to calculate the Akaike information criterion (AIC) for each model and assess the difference in AIC between the models. The AIC of a model is calculated by subtracting two times the degrees of freedom from the
2 estimate of the model (18). A higher AIC indicates better model performance. We used this technique to assess the value of MR imaging results as a replacement for radiographic results by comparing the AIC of model 1 with that of model 2 and also to assess the value of MR imaging results in addition to radiographic results by comparing the AIC of model 1 with that of model 4. A difference in AIC larger than 2.00 was considered significant. All analyses were performed by using software (SPSS for Windows, release 10.0.0; SPSS, Chicago, Ill).
Sample Size Calculation
The data for this study were obtained from a randomized controlled trial in which the costs and effectiveness of early MR imaging of knee trauma were evaluated. Hence, the number of independent variables that could be analyzed in the multivariable regression analysis was determined by the number of patients included in the randomized controlled trial: 109 included patients received treatment, and 80 patients did not need treatment. Since at least 10 patients with an event and 10 patients without an event are necessary for each independent variable in the multivariable logistic regression analysis (19), a maximum of eight independent variables could be analyzed.
| RESULTS |
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2 test) and were subsequently used in the multivariable analysis. Age of the patient was a significant predictor of treatment as a continuous variable, but the most significant association was found when age was dichotomous, with 30 years as the threshold value (P = .01). Compared with no MR imaging information, abnormal MR imaging results were predictive of the need for treatment, whereas normal MR imaging results were predictive of no treatment required. Similarly, in regard to the overall imaging variable, the category in which radiographic and MR imaging results were both abnormal was significantly predictive of treatment, and the category in which radiographic and MR imaging results were both normal was significantly predictive of no treatment required. The two intermediate categories had no significant association with treatment. As expected, sex and side of trauma were not significant in the univariable analysis (P = .36 and .61, respectively).
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Repeating the analysis with isolated bone marrow edema defined as an MR imaging finding that required additional treatment did not change the significance of any of the predictors in the univariable and multivariable analyses (data not shown). Similarly, in the separate analysis in which physical therapy was not considered a specific treatment, we found the same significant predictors in the univariable analysis. In the multivariable analysis, age was only a significant predictor in model 1, but the significance of the imaging variables in all models was not affected (data not shown). Also, all odds ratios of the imaging variables and the model performance statistics were similar.
| DISCUSSION |
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With four multivariable logistic regression models, we assessed the value of a dedicated extremity MR imaging examination, when performed in addition to and instead of radiography, for the prediction of the need for additional treatment in patients with acute knee trauma. Contrary to what we expected, the results of this study suggested that such an MR imaging examination has limited additional value for the prediction of the need for treatment. Although the MR imaging results variable was significant in the prediction of the need for treatment when added to the model with radiographic results, compared with no MR imaging information available, neither abnormal nor normal MR imaging results had significant added predictive value. As an alternative to radiographic results, MR imaging results were only significantly predictive of treatment if they were abnormal, and they did not contribute to the identification of patients who would not require treatment and who could be discharged without follow-up.
Although inclusion was intended to be consecutive, only about half of the eligible patients were randomized. Patients could be included daily from 8:00 AM to 11:00 PM. Many different radiology technologists on service were responsible for asking patients to participate, and they forgot to do so regularly despite multiple efforts by the investigators to improve recruitment. In many instances, patients who were not included could not be traced, so that we could not determine the exact number of missed eligible patients. Since we could not identify a systematic pattern in regard to the characteristics of missed patients, we assume that this suboptimal patient inclusion did not cause substantial selection bias, but it cannot be ruled out.
We used a short MR imaging protocol, which may partly account for the limited additional value of MR imaging that we found in our study. We believe, however, that a more expanded protocol or a protocol that is used in daily practice (routine) for nonemergency patients is not feasible for routine application in the emergency setting because of the excess burden to the patient, with the longer examination time and the higher costs. Furthermore, the aim was to use this protocol as a triage tool to distinguish patients who require treatment from patients who can be discharged without further follow-up. Considering this purpose, we think that a less extensive MR imaging technique than is commonly used for a regular MR imaging examination should suffice.
Our method of interpretation of the MR imaging results also may have influenced the results of this study. We considered an MR imaging study to be abnormal only if one or more lesions that generally require therapy were visible. Visible lesions that are usually not treated, such as a partial rupture of the anterior cruciate ligament, were not counted as abnormal when we used this definition (26,27). Although this is justified in the majority of cases, we recognize that exceptions are possible in specific patient groups, such as professional athletes. Therefore, the results of this study must be judged by taking into consideration the classification method of the MR imaging findings. Although bone marrow edema does not require specific treatment, it can be an indirect manifestation of another lesion; therefore, such a finding may increase the likelihood of treatment. We performed a separate analysis in which isolated bone marrow edema was interpreted as an MR imaging finding that required additional treatment, but results of this analysis did not change the significance of any predictor.
Apart from radiologic techniques, we assessed the predictive value of clinical factors such as age and trauma mechanism. Older age is associated with a higher prevalence of degenerative knee disorders, and this higher prevalence, in turn, is associated with increased likelihood of structural damage after trauma. For example, a meniscal tear occurs more easily in patients who have a meniscus with myxoid degeneration than in those who have an unaffected meniscus. In our analysis, an age of older than 30 years was found to be significantly predictive of treatment required. Older age also is associated with a higher prevalence of preexisting asymptomatic meniscal tears, but symptoms in a patient with such a condition often are not due to that tear itself and will usually resolve within a few months if there are no other abnormalities in the knee joint. Because of the long waiting period for arthroscopy in our institution, it is therefore unlikely that preexisting asymptomatic meniscal tears were unnecessarily treated in our study.
We also recorded whether the mechanism of injury was a direct blow or an indirect trauma, usually due to rotational force or varus or valgus stress, which has been shown to give rise to different patterns of findings at MR imaging (28,29). Whereas a direct hit more often gives rise to a fracture, an indirect trauma more frequently causes meniscal tears, ligament ruptures, and osteochondral lesions and was found to be a significant predictor of the need for treatment in this study.
A potential limitation of this study was that we did not assess the predictive value of findings at physical examination. The accuracy of physical examination of the knee joint, however, has been controversial, especially if performed in the acute stage after injury. It has been widely recognized that extensive joint swelling, pain, or guarding render physical examination without anesthesia inaccurate in the early stage after injury (68), which was the period of interest in this study. Moreover, it has been reported that the accuracy of physical examination of the knee is influenced by the experience of the physician (30).
Another limitation of this study was that we defined treatment within the follow-up period as the outcome measure, assuming that this truly reflected the need for treatment in all patients. It is possible, however, that patients were incorrectly discharged from further treatment and follow-up or that patients received unnecessary treatment. We believe that the assumption is justified for patients who were identified as those who did not require therapy. If treatment were incorrectly withheld in the initial stage, these patients would likely have returned and received treatment within the 6 months of follow-up because of persisting symptoms. On the other hand, the appropriateness of a treatment that a patient has already undergone is difficult to assess in retrospect, and we were unable to identify patients who had been treated unnecessarily. Since the treatment of the various lesions was not standardized, the decision to treat and the type of treatment varied across physicians. We would not expect this to influence the results of our study, however, since differences in type of treatment did not affect the outcome measured. Only a difference in the choice of whether or not to treat a patient influenced the outcome, as discussed previously.
Follow-up of patients in this study was limited to a period of 6 months after their initial visit to the emergency department. Although one might argue that we may have incorrectly classified patients in whom treatment was initiated after this 6-month period as having undergone no treatment, we believe that this is rarely the case, since therapy for traumatic lesions of the knee joint is generally initiated soon after the injury, if necessary. Nonetheless, we found that in some cases surgery was performed after the 6-month follow-up period because of the waiting time for arthroscopy. This was the reason why we did not use the need for surgery as an alternative outcome measure in this study. In all of these patients, however, physical therapy had already been initiated within 6 months after first presentation so that these patients were dealt with correctly in our analysis. We acknowledge that the indications for physical therapy are often not well defined, so it can be argued that physical therapy should not count as a specific treatment. Therefore, we repeated the analysis in which physical therapy was not considered a specific treatment, but results of this repeat analysis did not change the conclusions of our study.
With results of this study, one can conclude that a prediction of the need for treatment in patients who present after acute knee trauma can be made on the basis of age, trauma mechanism, and the radiographic results. To apply this prediction rule in clinical practice would require choosing the optimal threshold score, which requires consideration of the likelihood of a treatable lesion and weighing the benefit gained by making a correct prediction against the consequences of making an incorrect prediction, in terms of expected effectiveness and costs. The optimal threshold value of the prediction rule represents the combination of true- and false-positive ratios that yield the greatest expected utility for the patient at acceptable costs to society (16).
We conclude that the value of a dedicated extremity MR imaging examination in the initial stage after knee trauma is limited. A short MR imaging examination, in addition to or instead of radiography, improves the prediction of the need for additional treatment in patients with traumatic knee injury but does not significantly aid in the identification of patients who can be discharged without further follow-up.
| ACKNOWLEDGMENTS |
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| FOOTNOTES |
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Author contributions: Guarantor of integrity of entire study, M.G.M.H.; study concepts and design, all authors; literature research, E.H.G.O., J.J.N.; clinical studies, E.H.G.O., J.J.N.; data acquisition and analysis/interpretation, all authors; statistical analysis, E.H.G.O., J.J.N.; manuscript preparation, definition of intellectual content, revision/review, and final version approval, all authors; manuscript editing, E.H.G.O.
See also the articles by Nikken et al in this issue.
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