| HOME | HELP | FEEDBACK | SUBSCRIPTIONS | ARCHIVE | SEARCH | |
Commentary & Perspective | ||||||||
Commentary & Perspective on With this excellent investigative effort, Buckley et al. have answered important questions about whether and when surgical reduction and rigid internal fixation improves the outcomes of displaced intra-articular calcaneal fractures. They reported the results of a prospective, multicenter, randomized clinical trial comparing operative with nonoperative treatment. The nonoperative treatment in the study included rest, ice, and elevation. The surgical protocol involved an extended lateral approach, open reduction, and internal fixation with plates, screws, or wires. No specialized surgical training was provided to the treating surgeons. The outcomes were measured with use of a general health-outcome form, the SF-36, and the authors' previously published but not widely employed visual analog scale (VAS). A single investigator performed the fracture classification and the radiographic measurements of the reduction. The conclusions of this study bear repeating. Patients who receive Workers' Compensation do not show improvement that can be measured with the SF-36 or the authors' VAS after surgical care. However, when the patients who received Workers' Compensation were excluded from the data analysis, the outcomes were significantly better (p < 0.05) in some subsets of patients after surgical care. The patients who were not receiving Workers' Compensation and who were treated surgically were more likely to have a satisfactory outcome than were those treated nonoperatively. The likelihood of an improved outcome after surgical care as indicated by the satisfaction scores among these patients varied from 1.88 (relative risk) to 8.09 (odds ratios). Factors that enhanced the likelihood of a satisfactory outcome were younger patient age (twenty to twenty-nine years), a low-energy injury as measured by several classification systems and a moderate depression in the Böhler angle, anatomic reduction, female gender, and a light workload. It is known that displaced calcaneal fractures do not have particularly good outcomes1. Though open treatment has gradually become the standard of care in the community, that community standard is based on observation and the poor prognosis of alternative care. The data supporting open treatment have been limited by small sample size, lack of controls, and nonhomogeneous reporting2-4. Through its rigorous design, the randomized, controlled trial, which reduces the risk that bias will be introduced, is the gold standard for evaluating the efficacy of medical treatment. The standards for the design of a randomized, controlled trial are well-accepted. A medical study in humans must adhere to the Declaration of Helsinki and to regulatory requirements, include comparable control groups, provide a complete account of all subjects, carefully monitor for patient safety and efficacy of treatment, and randomize and analyze data with use of accepted techniques5. In addition, therapeutic randomized trials must demonstrate "clinical equipoise" between the two comparison groups. Clinical equipoise is defined as a lack of preference, in a rational, informed person, for one of two or more available treatments6. There are other significant challenges inherent in surgical randomized trials that don't exist in nonsurgical clinical trials. First, the trial cannot be conducted in a double-blind fashion unless sham surgery is performed and a noninvolved medical specialist evaluates the patient outcomes. Second, standardization of procedures cannot be accomplished to the degree that is possible in nonsurgical medical trials. Third, there is an ethical dilemma in a surgical trial because the surgeon may believe that he or she is performing surgery that may not help the patient. For this reason, both the patient and the physician are more reluctant to accept randomization of treatment in a surgical trial than they are in a nonsurgical clinical trial7. The way that Buckley et al. addressed these issues has some impact on how the data can be interpreted and applied. Though they could not blind either patients or physicians, Buckley et al. addressed the issue by enrolling large numbers of patients and utilizing two different outcome scales, which should compensate for the lack of blinding. The clinical equipoise of closed and open management among the surgical community obviated the challenges of sham surgery. The second issue—standardization of surgical care—was addressed by mandating a lateral approach and rigid internal fixation. Each surgeon was required to recruit a minimum of twenty patients. In this trial 73% of the patients were enrolled by a single surgeon, and 27% (103 of the fractures analyzed at final follow-up) by the other five surgeons. We know that in other types of surgery, increased surgeon volume leads to better outcomes. Could the benefit to the patients be enhanced if the surgeons had specialized training or if the surgical care was provided only by surgeons who had performed fifty or more of these procedures?8 Surgeons may find it difficult to admit to genuine uncertainty in the choice of a treatment and to communicate that uncertainty to a patient. The surgeon's uncertainty may affect the patient's trust and willingness to participate in the trial7. To some extent, the more skilled a surgeon is in performing a particular procedure, the better his or her outcomes tend to be, and the less likely that the surgeon will participate in a randomized surgical trial. This suggests that less experienced surgeons would be more likely to participate in randomized trials. The authors of this study—which began more than ten years ago—were hampered by the lack of a validated outcome tool for treatment of these fractures; a lack of reasonable stratification data; an unknown effect size, precluding establishment of a power calculation before the study; and a young and relatively inexperienced group of surgeons. The authors have done an exceptional job of addressing these challenges. We now know, with statistical support, that surgical care of displaced calcaneal fractures improves the likelihood of a good outcome. What further conclusions might a clinician draw from this study that will help him or her to make treatment decisions in individual cases? Would it be reasonable to decide to repair a fracture that has a Böhler angle of 1° but not one with a Böhler angle of –1°? Should we stop providing surgical treatment to all patients who receive Workers' Compensation because the outcome tools do not measure improvement in that population as a whole although we know that surgical treatment improves outcomes in other groups of patients? Clinicians now have the data to assist them in making these decisions along with their patients. These data can also be used as a basis for further investigation of questions such as how specialized training in management of complex fractures might enhance the benefits of surgical reduction. Treating physicians and injured patients are indebted to Buckley et al. and to the patients who consented to enroll in this trial. *The author did not receive grants or outside funding in support of the research or preparation of this manuscript. He did not receive payments or other benefits or a commitment or agreement to provide such benefits from a commercial entity. No commercial entity paid or directed, or agreed to pay or direct, any benefits to any research fund, foundation, educational institution, or other charitable or nonprofit organization with which the author is affiliated or associated. References 1. Kitaoka HB, Schaap EJ, Chao EY, An KN. Displaced intra-articular fractures of the calcaneus treated non-operatively. Clinical results and analysis of motion and ground-reaction and temporal forces. J Bone Joint Surg Am. 1994;76:1531-40. | ||||||||
| ||||||||