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J Am Acad Orthop Surg, Vol 14, No 10, September 2006, S205-S210.
© 2006 the American Academy of Orthopaedic Surgeons
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Factors Influencing Outcome Following Limb-Threatening Lower Limb Trauma: Lessons Learned From the Lower Extremity Assessment Project (LEAP)

Ellen J. MacKenzie, PhD and Michael J. Bosse, MD

Dr. MacKenzie is Professor and Chair, Health Policy and Management, The Johns Hopkins University, Bloomberg School of Public Health, Baltimore, MD. Dr. Bosse is Director, Clinical Research, and Orthopaedic Traumatologist, Carolinas Medical Center, Charlotte, NC.

Dr. MacKenzie or the department with which she is affiliated has received research or institutional support from the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Neither Dr. Bosse nor the department with which he is affiliated has received anything of value from or owns stock in a commercial company or institution related directly or indirectly to the subject of this article.


   Abstract
Top
 Abstract
A Conceptual Framework
 Factors Influencing Outcomes...
 Implications for the Military
 Summary
 Figures
 Tables
 References
 
The Lower Extremity Assessment Project (LEAP) is a multicenter study of severe lower extremity trauma in the US civilian population. At 2- and 7-year follow-ups, the LEAP study found no difference in functional outcome between patients who underwent either limb salvage surgery or amputation. However, outcomes on average were poor for both groups. This study and others provide evidence of wide-ranging variations in outcome following major limb trauma, with a substantial proportion of patients experiencing long-term disability. In addition, outcomes often are more affected by the patient's economic, social, and personal resources than by the initial treatment of the injury—specifically, amputation or reconstruction and level of amputation. A conceptual framework for examining outcomes after injury may be used to identify opportunities for interventions that would improve outcomes. Because of essential differences between the civilian and military populations, the findings of the LEAP study may correlate only roughly with combat casualty outcomes.

Lower extremity injuries constitute a leading cause of hospital admissions among adolescents and young adults (ages 18 to 54 years), accounting for nearly 250,000 hospitalizations each year.1 More than one half of these admissions are for major extremity trauma involving open fractures, crush injuries, and major soft-tissue injuries resulting from motor vehicle crashes, pedestrian injuries, falls from heights, and industrial accidents. Lower extremity trauma is increasingly common in the military, as evidenced by the large number of limb injuries sustained in the recent conflicts in Iraq and Afghanistan. Few studies have examined the consequences of combat-related lower extremity trauma in general, although several studies have addressed the difficult recovery often associated with limb amputation.2-6

The Lower Extremity Assessment Project (LEAP) was a multicenter study of severe lower extremity trauma in the US civilian population.7-18 In this study, functional outcomes were assessed for 601 patients who underwent reconstruction or amputation following severe, limb-threatening lower extremity trauma. Although few significant differences in functional outcome were found for those undergoing amputation versus reconstruction, outcomes for both groups were poor on average. In a recently completed 7-year follow-up of the LEAP patients, the study group found that outcomes for these patients had not improved. One half of all patients had physical subscores on the Sickness Impact Profile (SIP) ≥10, indicative of significant disability; only 34% of patients achieved scores typical of a general population of similar age and sex. Furthermore, only 58% of those working before the injury were working at 7 years postinjury, and the working patients were, on average, limited in their ability to perform the demands of their jobs 20% to 25% of the time.10

This study and others19-30 provide evidence of wide-ranging variations in outcome following major limb trauma, with a substantial proportion of patients experiencing long-term disability. These studies further demonstrate that outcomes often are more affected by the patient's economic, social, and personal resources than by the initial treatment of the injury—specifically, amputation versus reconstruction and level of amputation.


   A Conceptual Framework
Top
 Abstract
 A Conceptual Framework
Factors Influencing Outcomes...
 Implications for the Military
 Summary
 Figures
 Tables
 References
 
Many factors influence functional outcomes, over and above the initial treatment of the injury and the extent of residual impairment.31-42 The relationships among these factors are multivariate and complex; nevertheless, as shown in Figure 1, some of the principal relationships can be established and a conceptual framework determined for examining postinjury outcomes.


Figure 00044041
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  		Figure 1 Conceptual framework for assessing outcomes following major limb trauma. ADL = activity of daily living, ASD = acute stress disorder, IADL = instrumental activity of daily living, PTSD = posttraumatic stress disorder

 
This framework recognizes that secondary conditions, such as medical complications (eg, infection, malunion), pain, acute stress disorder (ASD), posttraumatic stress disorder (PTSD), and depression, are common among persons with lower limb injuries. When present, these conditions can affect functional status, resulting in restrictions in activities and participation in life roles. These restrictions, in turn, influence general health perceptions and overall quality of life (QOL). Multiple characteristics of the individual and his or her environment influence the prevalence of these secondary conditions and their impact on function and QOL. Some of these characteristics are immutable or difficult to change (eg, age, sex, comorbidities, economic resources, social support networks, and personal traits such as hope); others are clearly mutable (eg, self-efficacy, catastrophizing, improved perceptions of social support).31-42

A growing body of literature illustrates the impact that high postinjury rates of the secondary conditions (eg, depression, anxiety, PTSD) have on functional outcomes and QOL. The diagnosis of ASD is among the first forms of psychopathology evident following injury. One study showed that 78% of persons with ASD after a motor vehicle crash go on to meet criteria for PTSD within 6 months.43 Prevalence rates of PTSD following motor vehicle crashes range from 24% to 39%;44,45 another 28.5% meet subthreshold criteria. Of motor vehicle crash survivors with PTSD at 1-year follow-up, 53% continued to maintain the diagnosis at 3-year follow-up.46

High rates of symptoms of depression and major depressive disorder have been observed following injury.24-35,47-50 At 2 years, 19% of LEAP study patients screened positive for severe depression and an equal number, for moderate depression.51 ASD, PTSD, and depression, in turn, have a profound impact on disability,52 return to work,34 health-related QOL,36 and prolonged poor adjustment.53 Even subclinical levels of PTSD are related to poor health-related QOL, specifically in psychological functioning, vitality, and social adjustment.53 Increased pain severity also has been associated with increased PTSD symptoms.54 Recent data underscore the high prevalence of mental health problems associated with combat duty in Iraq (not just among those sustaining injury). Hoge et al55 reported that 16.6% to 17.1% of persons deployed to Iraq screened positive for major depression, generalized anxiety, or PTSD.


   Factors Influencing Outcomes Among LEAP Patients
Top
 Abstract
 A Conceptual Framework
 Factors Influencing Outcomes...
Implications for the Military
 Summary
 Figures
 Tables
 References
 
Data from the LEAP study underscore the importance of these factors in explaining variations in outcome following lower limb trauma. Patient characteristics that were significantly associated with poorer outcomes included older age, female sex (for physical functioning only), nonwhite race, lower level of education, living in a poor household, being a current or past smoker, poor self-reported preinjury health status, and involvement with the legal system for obtaining disability payments (for psychosocial functioning only).7,9,10

Aside from these characteristics, however, the LEAP study group found that the presence of anxiety, pain, and depression at baseline (3 months after injury) were all significant predictors of poorer longer term outcome, as measured by the SIP and return to work (Table 1).


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  		Table 1 Sickness Impact Profile Scores and Return-to-Work Statistics by 3-Month Quartiles
 
Although PTSD was not measured in the LEAP study, the Brief Symptom Inventory56 was used to assess symptoms of general anxiety and depression. Pain was measured using a visual analogue scale.57 A clear pattern emerges in which increases in pain, anxiety, and depression are related to concomitant decreases in function and return to work. Using structural equation modeling techniques, the LEAP study group has further explored the complex relationships among these variables and found that pain affects SIP functional outcome largely through its influence on depression and anxiety.

The LEAP data further support the previously documented relationship7 between self-efficacy, social support, and outcome (Table 2).


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  		Table 2 Sickness Impact Profile Scores and Return to Work by Baseline Self-Efficacy and Social Support
 
In a multivariate analysis of the LEAP data,7,9,10 self-efficacy was one of the strongest predicators of SIP and return to work. Self-efficacy refers to the confidence in being able to perform specific tasks or activities. Persons with low self-efficacy are more likely to disengage from the coping process because failure is expected. Although the relationship between social support and outcome is not as strong, the LEAP and other studies have shown it to have important mediating effects on outcome.7,31,32,42

The results of the LEAP study strongly suggest that major improvements in functional outcome require interventions in the early postacute phase of recovery that directly address the patients’ psychosocial needs and assist them in self-managing the multifactorial consequences of injury. A significant body of research has shown that self-management interventions based on cognitive-behavioral theory are particularly effective in increasing self-efficacy, reducing secondary conditions such as pain, anxiety and depression, and improving overall function and QOL.58,59 These programs have gained widespread application with chronic conditions in which pain and disability are common. They have not, however, been broadly applied to younger, acutely injured individuals.


   Implications for the Military
Top
 Abstract
 A Conceptual Framework
 Factors Influencing Outcomes...
 Implications for the Military
Summary
 Figures
 Tables
 References
 
Although the results of the LEAP study may be considered comprehensive for the targeted population, the findings may only roughly correlate with combat casualty outcomes because of essential differences between the civilian and military populations. First, the LEAP study was an assessment of outcomes following major trauma to the lower limbs only. However, the incidence of upper and lower extremity injuries from the current conflicts in Iraq and Afghanistan are nearly equal. Recent small case series suggest that functional outcomes are better for upper extremity limb salvage compared with amputation. Function of the lower extremities primarily affects stance and ambulation, which current prostheses adequately support. Function of upper extremities, however, requires coordinated function of the digits and is dependent on sensation. Although current prostheses can provide gross motor movements such as grasp, in many instances they do not adequately restore fine motor function.

In addition, many of the risk factors for poor outcome in the LEAP study do not exist or are minimized in the military population. Service members are employed, have guaranteed health care, and have better preinjury physical conditioning. They also are likely to have higher levels of self-efficacy and, at least initially, have a psychosocial support network provided by their military units. For these reasons, it may be that service members undergoing amputation or reconstruction of a lower limb may indeed have better long-term outcomes.

However, there is concern that the extent of social support and self-efficacy may not remain as high after discharge from active duty. In addition, the rate of PTSD will be higher in military versus civilian populations. The general high incidence of mental health disorders has been recently reported by Hoge et al.55 The effect of PTSD and other mental health disorders on functional outcomes and QOL will be of major interest in any follow-up of service members with extremity injuries.

A limited amount of information about major limb trauma has begun to trickle in from the current conflicts in Afghanistan and Iraq. Most of the data, however, pertain only to those military personnel undergoing amputation, with less attention paid to the larger number of wounded whose limbs have been spared. Nevertheless, data from the LEAP study suggest that outcomes can be equally as poor for those undergoing reconstruction as for those undergoing amputation.

In a case series of orthopaedic injuries from the conflict in Afghanistan, Lin et al60 reported on the current doctrine of early irrigation, débridement, and skeletal stabilization of orthopaedic injuries in the forward deployed area, and definitive reconstruction after evacuation to a military medical facility in the continental United States (CONUS). They stated that early surgical treatment in the theater of operations improved their ability to reconstruct the injured extremities after evacuation to CONUS. This information is useful; however, considering the significance of severe penetrating upper extremity injuries on the battlefield, a thorough follow-up study of survivors is needed.


   Summary
Top
 Abstract
 A Conceptual Framework
 Factors Influencing Outcomes...
 Implications for the Military
 Summary
Figures
 Tables
 References
 
The LEAP study has shown that regardless of initial treatment option of amputation or reconstruction, long-term physical and psychosocial outcomes are often poor after major lower limb trauma. Several characteristics of the patient and his or her environment correlate with long-term outcome. Although some of these characteristics are difficult to change, others are clearly mutable and should be targeted in efforts to improve postacute care services. Self-management programs, shown to be effective in managing arthritis, diabetes, and other chronic diseases, may hold particular promise for patients experiencing the consequences of major limb trauma.

In addition, very little is known about the long-term consequences of limb-threatening injuries and their treatment in a military setting. Of particular interest and concern is the status of service members once they are discharged from care at one of the participating facilities and returned either home or to active duty. Procedures need to be established for a uniform, long-term follow-up to better define the clinical, functional, and QOL outcomes following major orthopaedic trauma. This long-term follow-up would serve two objectives. First, it would provide a unique opportunity to examine the benefits of reconstruction versus amputation in a military population, especially for those sustaining limb-threatening trauma to the upper versus the lower limb. The results will have important implications for the treatment of future patients with major upper limb trauma. Second, the study could be used to identify ongoing (postdischarge) needs for additional services and provide the basis for targeting interventions and conducting focused research on carefully selected aspects of long-term recovery. Over the long term, the proposed research will assist in ensuring that these service members are provided with every opportunity for a good long-term outcome.


   Figures
Top
 Abstract
 A Conceptual Framework
 Factors Influencing Outcomes...
 Implications for the Military
 Summary
 Figures
Tables
 References
 


   Tables
Top
 Abstract
 A Conceptual Framework
 Factors Influencing Outcomes...
 Implications for the Military
 Summary
 Figures
 Tables
References
 


   References
Top
 Abstract
 A Conceptual Framework
 Factors Influencing Outcomes...
 Implications for the Military
 Summary
 Figures
 Tables
 References
 

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