Marc F. Swiontkowski

Introducing Levels of Evidence to The Journal

Orthopaedic surgeons have always based their clinical care on evidence. Surgeons use evidence to make decisions tailored to an individual patients needs and circumstances. The primary sources of evidence for clinicians are studies published in the medical and surgical literature, such as The Journal of Bone and Joint Surgery. In June 2000, The Journal introduced the quarterly Evidence-Based Orthopaedics section 1. This section introduces orthopaedic surgeons to recent randomized trials relevant to the practice of orthopaedic surgery published in forty-two journals other than The Journal of Bone and Joint Surgery. Structured abstracts of these studies are …

Internal fixation compared with arthroplasty for displaced fractures of the femoral neck. A meta-analysis.

BACKGROUND The optimal choice for the stabilization of displaced femoral neck fractures remains controversial, with alternatives including arthroplasty and internal fixation. Our objective was to determine the effect of arthroplasty (hemiarthroplasty, bipolar arthroplasty, and total hip arthroplasty), compared with that of internal fixation, on rates of mortality, revision, pain, function, operating time, and wound infection in patients with a displaced femoral neck fracture. METHODS We searched computerized databases for randomized clinical trials published between 1969 and 2002, and we identified additional studies through hand searches of major orthopaedic journals, bibliographies of major orthopaedic textbooks, and personal files. Of 140 citations initially identified, fourteen met all eligibility criteria. Three investigators independently graded study quality and abstracted relevant data, including information on revision and mortality rates. RESULTS Nine trials, which included a total of 1162 patients, provided detailed information on mortality rates over the first four postoperative months, which ranged from 0% to 20%. We found a trend toward an increase in the relative risk of death in the first four months after arthroplasty compared with the risk in the first four months after internal fixation (relative risk, 1.27). At one year, the relative risk of death was 1.04. The risk of death after arthroplasty appeared to be higher than that after fixation with a compression screw and side-plate but not higher than that after internal fixation with use of screws only (relative risk = 1.75 and 0.86, respectively; p < 0.05). Fourteen trials that included a total of 1901 patients provided data on revision surgery. The relative risk of revision surgery after arthroplasty compared with the risk after internal fixation was 0.23 (p = 0.0003). Pain relief and the attainment of overall good function were similar in patients treated with arthroplasty and those treated with internal fixation (relative risk, 1.12 for pain relief and 0.99 for function). Infection rates ranged from 0% to 18%, and arthroplasty significantly increased the risk of infection (relative risk, 1.81; p = 0.009). In addition, patients who underwent arthroplasty had greater blood loss and longer operative times than those who were treated with internal fixation. CONCLUSIONS In comparison with internal fixation, arthroplasty for the treatment of a displaced femoral neck fracture significantly reduces the risk of revision surgery, at the cost of greater infection rates, blood loss, and operative time and possibly an increase in early mortality rates. Only larger trials will resolve the critical question of the impact on early mortality.

Treatment of open fractures of the shaft of the tibia

We have systematically reviewed the effect of alternative methods of stabilisation of open tibial fractures on the rates of reoperation, and the secondary outcomes of nonunion, deep and superficial infection, failure of the implant and malunion by the analysis of 799 citations on the subject, identified from computerised databases. Although 68 proved to be potentially eligible, only eight met all criteria for inclusion. Three investigators independently graded the quality of each study and extracted the relevant data. One study (n = 56 patients) suggested that the use of external fixators significantly decreased the requirement for reoperation when compared with fixation with plates. The use of unreamed nails, compared with external fixators (five studies, n = 396 patients), reduced the risk of reoperation, malunion and superficial infection. Comparison of reamed with unreamed nails showed a reduced risk of reoperation (two studies, n = 132) with the reamed technique. An indirect comparison between reamed nails and external fixators also showed a reduced risk of reoperation (two studies) when using nails. We have identified compelling evidence that unreamed nails reduced the incidence of reoperations, superficial infections and malunions, when compared with external fixators. The relative merits of reamed versus unreamed nails in the treatment of open tibial fractures remain uncertain.

Return to work following injury: the role of economic, social, and job-related factors.

OBJECTIVES This study examined factors influencing return to work (RTW) following severe fracture to a lower extremity. METHODS This prospective cohort study followed 312 individuals treated for a lower extremity fracture at 3 level-1 trauma centers. Kaplan-Meier estimates of the proportion of RTW were computed, and a Cox proportional hazards model was used to examine the contribution of multiple risk factors on RTW. RESULTS Cumulative proportions of RTW at 3, 6, 9, and 12 months post-injury were 0.26, 0.49, 0.60, and 0.72. After accounting for the extent of impairment, characteristics of the patient that correlated with higher rates of RTW included younger age, higher education, higher income, the presence of strong social support, and employment in a white-collar job that was not physically demanding. Receipt of disability compensation had a strong negative effect on RTW. CONCLUSIONS Despite relatively high rates of recovery, one quarter of persons with lower extremity fractures did not return to work by the end of 1 year. The analysis points to subgroups of individuals who are at high risk of delayed RTW, with implications for interventions at the patient, employer, and policy levels.

A prospective evaluation of the clinical utility of the lower-extremity injury-severity scores

Background: High-energy trauma to the lower extremity presents challenges with regard to reconstruction and rehabilitation. Failed efforts at limb salvage are associated with increased patient mortality and high hospital costs. Lower-extremity injury-severity scoring systems were developed to assist the surgical team with the initial decision to amputate or salvage a limb. The purpose of the present study was to prospectively evaluate the clinical utility of five lower-extremity injury-severity scoring systems. Methods: Five hundred and fifty-six high-energy lower-extremity injuries were prospectively evaluated with use of five injury-severity scoring systems for lower-extremity trauma designed to assist in the decision-making process for the care of patients with such injuries. Four hundred and seven limbs remained in the salvage pathway six months after the injury. The sensitivity, specificity, and area under the receiver operating characteristic curve were calculated for the Mangled Extremity Severity Score (MESS); the Limb Salvage Index (LSI); the Predictive Salvage Index (PSI); the Nerve Injury, Ischemia, Soft-Tissue Injury, Skeletal Injury, Shock, and Age of Patient Score (NISSSA); and the Hannover Fracture Scale-97 (HFS-97) for ischemic and nonischemic limbs. The scores were analyzed in two ways: including and excluding limbs that required immediate amputation. Results: The analysis did not validate the clinical utility of any of the lower-extremity injury-severity scores. The high specificity of the scores in all of the patient subgroups did confirm that low scores could be used to predict limb-salvage potential. The converse, however, was not true. The low sensitivity of the indices failed to support the validity of the scores as predictors of amputation. Conclusions: Lower-extremity injury-severity scores at or above the amputation threshold should be cautiously used by a surgeon who must decide the fate of a lower extremity with a high-energy injury.

Long-term persistence of disability following severe lower-limb trauma : Results of a seven-year follow-up

BACKGROUND A recent study demonstrated that patients treated with amputation and those treated with reconstruction had comparable functional outcomes at two years following limb-threatening trauma. The present study was designed to determine whether those outcomes improved after two years, and whether differences according to the type of treatment emerged. METHODS Three hundred and ninety-seven patients who had undergone amputation or reconstruction of the lower extremity were interviewed by telephone at an average of eighty-four months after the injury. Functional outcomes were assessed with use of the physical and psychosocial subscores of the Sickness Impact Profile (SIP) and were compared with similar scores obtained at twenty-four months. RESULTS On the average, physical and psychosocial functioning deteriorated between twenty-four and eighty-four months after the injury. At eighty-four months, one-half of the patients had a physical SIP subscore of > or = 10 points, which is indicative of substantial disability, and only 34.5% had a score typical of a general population of similar age and gender. There were few significant differences in the outcomes according to the type of treatment, with two exceptions. Compared with patients treated with reconstruction for a tibial shaft fracture, those with only a severe soft-tissue injury of the leg were 3.1 times more likely to have a physical SIP subscore of 5 points (p < 0.05) and those treated with a through-the-knee amputation were 11.5 times more likely to have a physical subscore of 5 points (p < 0.05). There were no significant differences in the psychosocial outcomes according to treatment group. Patient characteristics that were significantly associated with poorer outcomes included older age, female gender, nonwhite race, lower education level, living in a poor household, current or previous smoking, low self-efficacy, poor self-reported health status before the injury, and involvement with the legal system in an effort to obtain disability payments. Except for age, predictors of poor outcome were similar at twenty-four and eighty-four months after the injury. CONCLUSIONS The results confirm previous conclusions that reconstruction for the treatment of injuries below the distal part of the femur typically results in functional outcomes equivalent to those of amputation. Regardless of the treatment option, however, long-term functional outcomes are poor. Priority should be given to efforts to improve post-acute-care services that address secondary conditions that compromise optimal recovery.

Impact of Smoking on Fracture Healing and Risk of Complications in Limb-threatening Open Tibia Fractures

Objectives: Current data show smoking is associated with a number of complications of the fracture healing process. A concern, however, is the potential confounding effect of covariates associated with smoking. The present study is the first to prospectively examine time to union, as well as major complications of the fracture healing process, while adjusting for potential confounders. Setting: Eight Level I trauma centers. Patients: Patients with unilateral open tibia fractures were divided into 3 baseline smoking categories: never smoked (n = 81), previous smoker (n = 82), and current smoker (n = 105). Outcome Measure: Time to fracture healing, diagnosis of infection, and osteomyelitis. Methods: Survival and logistic analyses were used to study differences in time to fracture healing and the likelihood of developing complications, respectively. Multivariate models were used to adjust for injury severity, treatment variations, and patient characteristics Results: After adjusting for covariates, current and previous smokers were 37% (P = 0.01) and 32% (P = 0.04) less likely to achieve union than nonsmokers, respectively. Current smokers were more than twice as likely to develop an infection (P = 0.05) and 3.7 times as likely to develop osteomyelitis (P = 0.01). Previous smokers were 2.8 times as likely to develop osteomyelitis (P = 0.07), but were at no greater risk for other types of infection. Conclusion: Smoking places the patient at risk for increased time to union and complications. Previous smoking history also appears to increase the risk of osteomyelitis and increased time to union. The results highlight the need for orthopaedic surgeons to encourage their patients to enter a smoking cessation programs.

Fractures of the proximal part of the femur.

The orthopaedic surgeon has a multitude of internal fixation devices and techniques available for use in the treatment of subtrochanteric fractures of the proximal femur. The successful use of second-generation locking nails is technically demanding. Close attention to positioning of the patient, reduction of the fracture, placement of the guide-wire, and insertion of the nail and of the proximal and distal locking screws is mandatory. The newer, high-strength hip-screws allow good fixation of a fracture that extends into the piriformis fossa. If medial comminution is present, this technique is best performed in conjunction with indirect reduction and bone-grafting. With proper technique, these devices allow the surgeon to manage predictably a complex subtrochanteric fracture that previously had to be treated with traction or extensive dissection and with (frequently inadequate) internal fixation.

Barriers to full-text publication following presentation of abstracts at annual orthopaedic meetings.

Background: Oral presentations at national and international meetings offer an excellent forum for the dissemination of current research findings. However, publication rates of full-text articles after presentation of abstracts at international meetings have ranged from 11% to 78%, which suggests that at least 32% of the abstracts presented are never published as complete articles in peer-reviewed journals. In an effort to identify the reasons that surgeons had not had a paper published following presentation of their work at an international orthopaedic meeting, we conducted a survey of a cross section of authors of orthopaedic papers presented at a national meeting.Methods: We retrieved all abstracts from the 1996 scientific program of the sixty-third Annual Meeting of the American Academy of Orthopaedic Surgeons. A computerized Medline and PubMed search established whether the abstract had been subsequently published as a full-text article. The authors of the abstracts that had not been subsequently published were surveyed to identify the reasons for the failure to publish.Results: A total of 465 abstracts were presented at the sixty-third Annual Meeting of the American Academy of Orthopaedic Surgeons in 1996. We surveyed the authors of 306 abstracts for which we were unable to locate a subsequent full-text publication on Medline. One hundred and ninety-nine investigators (65%) responded to the questionnaire. At the time of the survey, seventy-two manuscripts had been published, thirty-two had been submitted and rejected, fourteen were under consideration by journals, seven had been accepted for publication or were in press, and three were not recalled by the investigator. In addition, seventy-one abstracts (35.7%) of the 199 had not been submitted for publication. The authors of those abstracts were asked to indicate one or more reasons why they had not submitted a manuscript for publication. Thirty-three investigators (46.5%) indicated that they lacked sufficient time for research activities, twenty-two (31.0%) reported that the study presented at the meeting in 1996 was still in progress, fourteen (19.7%) believed that the responsibility for writing the manuscript belonged to someone else, and twelve (16.9%) reported that difficulties with co-authors who would not participate had impeded the completion of the manuscript. Nine investigators (12.7%) responded that the pursuit of publication was a low priority.Conclusions: In a survey of investigators who had not had a full-text article published after presenting the abstract at a national meeting, we found that the failure to publish was due to one of three main reasons: (1) they did not have enough time to prepare a manuscript for publication (the reason most frequently given); (2) almost one-third of the studies that had not been submitted for publication were ongoing; and (3) relationships with co-authors sometimes presented a barrier to final publication. Thorough preparation before the study and the establishment of stricter guidelines to limit the presentation of preliminary data at national and international meetings may improve publication rates.

Treatment of type II, IIIA, and IIIB open fractures of the tibial shaft: a prospective comparison of unreamed interlocking intramedullary nails and half-pin external fixators.

OBJECTIVE To compare unreamed intramedullary nailing (IMN) with external fixation (EF) in patients with Type II, IIIA, and IIIB open fractures of the tibial shaft. DESIGN An inception cohort of consecutive patients with Type II, IIIA, and IIIB tibial fractures incurred between January 1988 and March 1993 were systematically allocated into one of two treatment groups. Patients were treated and followed with a prospectively designed protocol. PATIENTS AND SETTING All patients were skeletally mature and had incurred a fracture of the tibial diaphysis within twenty-four hours of presentation to the tertiary care hospital, a Level I Trauma Center. One hundred seventy-four fractures in 168 patients were stabilized with either IMN (104) or half-pin EF (70). There were 132 men and thirty-six women, with an average age of thirty-three years (range, 14 to 77 years). INTERVENTION Except for the selection of the fixation device, open fracture care was similar in the two treatment groups. All patients underwent emergent irrigation and debridement with concomitant skeletal stabilization. Cephalosporin antibiotics were administered perioperatively for twenty-four to forty-eight hours. No wounds were closed primarily. Delayed primary closure, skin grafting, and/or myoplasty were performed between three and ten days after injury. MAIN OUTCOME MEASURES The main outcome measures were final fracture alignment, presence of infection or inflammation, hardware failure, time to union, and the number of operative procedures. RESULTS The IMN group had significantly fewer incidences of malalignment than did the EF group [8 vs. 31 percent; p = 0.00005; confidence interval (CI) = 0.18, 0.76] and had significantly fewer subsequent procedures (mean of 1.7 vs. mean of 2.7 per fracture; p = 0.001; CI = 0.45, 1.59). IMN resulted in fewer infections/ inflammatory problems than did EF at the injury site (13 vs. 21 percent; p = 0.73; CI = -0.63, 0.45) and significantly fewer at surgical interfaces (i.e., pin sites, nail and interlocking screw insertion sites; 2 vs. 50 percent; p = 0.000; CI = 0.39, 0.60). No significant difference was found in the healing rates for the two implant groups. The more severe Gustilo injury types had longer healing times regardless of the type of fixation. CONCLUSIONS Results suggest that unreamed interlocking intramedullary nails are more efficacious than half-pin external fixators, in particular with regard to maintenance of limb alignment. However, the severity of soft tissue injury rather than the choice of implant appears to be the predominant factor influencing rapidity of bone healing and rate of injury site infection.