Abstract
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
=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.
Level of Evidence: Prognostic Level II. See Instructions
to Authors for a complete description of levels of evidence.
Advances in surgical technique have increased the proportion of
severe lower-extremity injuries for which successful limb reconstruction is
technically
feasible1-3.
However, there is still controversy about when limb reconstruction is
advisable and in the best interest of the
patient1-9.
A recent study showed that the functional outcomes of amputation and
reconstruction were comparable at two years after the
injury10. Of
considerable note were the high levels of disability reported at two years
after the injury, regardless of the severity or treatment of the injury. A
major limitation of that study, however, was the relatively short (two-year)
follow-up. Many patients still have not completely recovered by two years. It
seems reasonable to expect some improvement in function over time. The
resolution of a fracture nonunion may improve the long-term functional status
of patients who have undergone reconstruction, whereas continued modification
of the prosthetic fit and increased comfort and confidence with use of the
prosthetic device could improve the long-term function of a patient who has
had an amputation. However, there is also the risk of function worsening. On
the basis of the findings of clinical examinations performed at two years
following treatment of lower-limb injuries, it was anticipated that 15% of all
patients (19% of those who have undergone reconstruction and 5% of those with
an amputation) require additional
surgery10. Both
groups are at risk for the development of secondary conditions that may
compromise the quality of long-term functional outcomes.
The purpose of this study was to assess functional outcomes seven years
following limb-threatening trauma and to observe whether differences according
to the type of treatment emerged later than two years after the injury. We
hypothesized that, while both treatment groups would show some improvement in
physical functioning, the patients who had undergone reconstruction would have
better overall outcomes at seven years following the injury. This hypothesis
was based on the shape of the two-year recovery curves. Patients who had
undergone amputation recovered more quickly than those who had undergone
reconstruction, but their level of functioning appeared to plateau by six
months after the injury. In contrast, patients who had undergone
reconstruction continued to recover over the two-year period, albeit more
slowly. By twenty-four months after the injury, both groups were functioning
at similar levels.
A secondary objective of this seven-year analysis was to determine whether
the risk factors shown to predispose patients to better or worse outcomes at
two years after the injury would also predispose them to better or worse
outcomes at seven years after the injury. Factors that predisposed patients to
worse outcomes at two years included major complications, a lower level of
education, nonwhite race, poverty, a lack of private health insurance, heavy
smoking, low levels of self-efficacy and social support, and involvement with
disability compensation
litigation10.
The Lower Extremity Assessment Project (LEAP) is a prospective
cohort study of 601 patients who had been admitted to eight level-I trauma
centers for treatment of a severe lower-extremity injury below the distal part
of the
femur10,11.
These individuals were initially assessed at the time of discharge from the
trauma center and then were followed at three, six, twelve, and twenty-four
months after the injury. At the time of each follow-up, the patients were
asked to participate in (1) an orthopaedic evaluation to ascertain the
occurrence of complications and the status of the involved limb, (2) an
evaluation by a physical therapist to ascertain the extent of impairment and
functional limitation, and (3) an interview to measure the patient's
perception of his or her functional status and overall sense of well-being. At
approximately seven years after the injury, an attempt was made to locate and
interview by telephone all LEAP participants who had completed at least one
follow-up interview within the first two years after the injury.
Study Population
As described in detail
elsewhere10,11,
to be eligible for participation in the LEAP study, a patient had to be
between the ages of eighteen and sixty-nine years and have one or more of the
following injuries to the lower extremity: a Gustilo Grade-IIIB or IIIC
fracture12, one of
the selected Grade-IIIA fractures, a dysvascular limb (a knee dislocation,
closed tibial fracture, or penetrating wound with a vascular injury), a major
soft-tissue injury to the tibia (a degloving or severe crush/avulsion injury),
and a severe foot injury (an open pilon or Grade-IIIB ankle fracture or a
severe hindfoot or mid-foot injury). Patients were excluded if they had a
major brain injury (a score of <15 on the Glasgow Coma
Scale13 at
twenty-one days after the injury or at the time of discharge), a spinal cord
deficit, a previous leg or foot amputation, or a third-degree burn on the
injured leg. Also excluded were patients who had been transferred to the
participating center more than twenty-four hours after the injury, those who
did not speak English or Spanish, those with a documented psychiatric disorder
or mental retardation, and those who were on active military duty or who lived
outside the hospital's catchment area.
Thirty-two patients who met the study criteria but had bilateral injuries
were excluded from the present analysis. Of the remaining 569 patients who had
a unilateral injury of the type included in the study, 149 had undergone
amputation prior to discharge from the acute hospitalization setting,
including thirty-two who had had an amputation of the leg at the time of
admission. After the initial discharge, twenty-seven additional patients
underwent amputation: twelve, within the first three months after the injury;
six, between three and six months; seven, between six and twenty-four months;
and two, between twenty-four and eighty-four months. Twenty-eight percent of
the patients sustained an additional injury to the ipsilateral leg, 19%
sustained an additional injury to the contralateral leg, and 56% sustained
injuries to other body regions.
Of the 569 LEAP patients with a unilateral injury of the type included in
the study, 511 (89.8%) were successfully followed at three months; 510
(89.6%), at six months; 510 (89.6%), at twelve months; 466 (81.9%), at
twenty-four months; and 413 (72.6%), at eighty-four months. The reasons for
loss to follow-up before eighty-four months included the patient's refusal to
participate in the study (n = 9), an inability to locate the patient (n =
123), incarceration or institutionalization (n = 6), and other reasons (n =
18). Patients with incomplete data were more likely to be male, nonwhite, and
without a high-school education (p < 0.05). However, rates of follow-up did
not differ significantly between the two treatment groups (amputation and
reconstruction) or according to the extent or severity of the leg injury.
Sixteen patients (nine treated with reconstruction and seven, with an
amputation) died within seven years after the injury (two died within the
first twenty-four months and fourteen, between twenty-four months and
eighty-four months). The analysis presented herein is based on the 397
patients who were alive and available for follow-up at an average of seven
years (range, seventy to ninety months) after the injury.
Measurement of Functional Outcome
Functional status was measured with use of the physical and psychosocial
subscores of the Sickness Impact Profile
(SIP)14,15.
The SIP is a multidimensional measure of self-reported health status
consisting of 136 statements about limitations in twelve categories of
function: (1) walking, (2) mobility, (3) body care and movement, (4) social
interaction, (5) alertness, (6) emotional behavior, (7) communication, (8)
sleep and rest, (9) eating, (10) work, (11) home management, and (12)
recreation. Respondents are asked to endorse statements that describe their
health status on a given day. Scores are calculated for the overall
instrument, for each of the twelve categories listed above, and for two major
dimensions of health (physical health, summarizing limitations in the first
three categories, and psychosocial health, summarizing limitations in the
second four categories). An investigator administered the entire SIP
instrument in person at three, six, twelve, and twenty-four months. Because
the eighty-four-month follow-up was limited to a telephone interview, only
those questions that were needed to calculate the physical and psychosocial
subscale scores were asked (i.e., the questions pertaining to sleep and rest,
eating, work, home management, and recreation were excluded). An SIP score of
>10 points represents substantial disability, and differences of 2 to 3
points reflect meaningful differences in function. Overall SIP scores range
between 2 and 3 points for the general
population16,17.
Measurement of Covariates of Outcome
Because treatment was not assigned randomly in this study, it was important
to fully characterize the patients and injuries in the two treatment groups
and to adjust for differences. Factors that were hypothesized to influence the
type of treatment (amputation or reconstruction) and/or the SIP outcomes
included characteristics of the LEAP study injury as well as injuries
sustained in association with the study injury, post-acute-care complications,
and characteristics of the patient and his or her environment.
At the time of admission and at the time of soft-tissue coverage, all leg
injuries were prospectively classified with use of the
Gustilo12 and
Tscherne18 fracture
classifications; the AO/OTA classification of long-bone fractures and
soft-tissue
injury19,20;
and components of the Mangled Extremity Severity Score
(MESS)21, the
Hannover Fracture
Scale22, the Limb
Salvage Index
(LSI)23, and the
Predictive Salvage Index
(PSI)24. As
described
elsewhere10,25,
these instruments were used to characterize each study injury according to the
type and extent of osseous damage, extent of soft-tissue injury, initial pulse
assessment, and plantar sensation. The severity of associated injuries (i.e.,
injuries to the leg that did not meet the study inclusion criteria or injuries
to other body regions) was classified with use of the Abbreviated Injury Scale
(AIS)26. AIS scores
were used to derive Injury Severity Scale (ISS)
scores27 and two
scores denoting the severity of contralateral and ipsilateral non-study leg
injuries. Shock was defined as a systolic blood pressure of <90 mm Hg prior
to the initiation of resuscitation.
To account for the impact of complications on recovery, a variable was
constructed to indicate rehospitalization for late amputation or stump
revision, fracture nonunion, hardware failure, flap loss, wound infection,
osteomyelitis, or more than one of those conditions.
Characteristics of the patient that have been hypothesized to influence
outcome have been described in detail
elsewhere11 and are
summarized in Table I. The
information necessary to derive these measures was obtained as part of the
hospital discharge interview. When respondents were interviewed for this
purpose, they were asked to think about themselves before the injury. Wherever
possible, standard measures of known reliability and validity were used.
Statistical Methods
The mean SIP scores at twenty-four and eighty-four months were first
compared within each treatment group to determine whether there was
improvement in function over time. The distributions of the eighty-four-month
SIP scores were then examined in greater detail. As the distributions of these
scores were skewed toward better (lower) values, subsequent analyses focused
on two measures of adverse outcomes defined by different cutoff points: (1)
SIP scores of =5 points and (2) SIP scores of =20 points. The first
measure (=5 points) identifies the subgroup of patients who do not achieve
scores in the range typically reported for the general population—i.e.,
the patients who do not "fully" recover. The second measure is
used to identify patients who have a particularly poor outcome, as SIP scores
of =20 points are indicative of very severe disability. Logistic regression
techniques were then used to determine whether the proportions of patients
with adverse outcomes were significantly different between treatment groups
after adjustment for all other factors hypothesized to affect outcome.
Stepwise procedures were used to develop a model incorporating only those
variables that were significant (p < 0.05) when they were considered in the
context of other variables. The extent to which the effect of patient
characteristics on SIP outcomes differed between injuries resulting in
amputation and injuries treated with reconstruction was examined by
incorporating the appropriate interaction terms into the model. The size and
significance of the effects were summarized by the relative odds of adverse
outcomes and their associated 95% confidence intervals.
Treatment was defined with use of eight categories. Amputation was
classified according to its level: below the knee, above the knee, through the
knee, and whole or partial foot. Reconstruction was classified according to
the principal injury that had been sustained: tibial shaft fracture, articular
fracture of the tibia, foot fracture, and soft-tissue injury. Amputations
performed within the first three months after the injury (n = 12) were
classified in the appropriate amputation group, whereas patients who underwent
amputation more than three months after the injury (n = 15) were considered to
be in the reconstruction group. Analysis was performed with and without
inclusion of the patients who underwent these late amputations. When they were
included, they were identified as having had a major complication. Results
were similar whether or not patients with late amputation were included.
Because treatment assignments were not randomized in this study, it was
necessary to statistically adjust the data to remove potential bias arising
from the likelihood that more severely injured patients are more likely to
undergo amputation. Two parallel approaches were used. The first approach
involves entering all of the characteristics of the injury directly into a
regression model together with other factors hypothesized to influence
outcome. With the second approach, logistic regression techniques are used to
first model the decision to amputate or reconstruct as a function of the
injury covariates. The results of the regression analysis are then used to
estimate a single score that forecasts the likelihood of an amputation. These
scores, hereafter referred to as p-amp scores, are subsequently used together
with other covariates in a regression to model SIP scores. Patients who arrive
at the hospital with a functionally severed leg are assigned a p-amp score of
1.00. These two approaches yield similar results; the models using the p-amp
score are reported in this paper.
The mean values for both the physical and the psychosocial subscores
of the SIP were significantly worse at eighty-four months than they were at
twenty-four months (p < 0.05) (Table
II). The increase (worsening) in the SIP scores was consistent
across all treatment groups. More than one-third (37.6%) of all patients
(39.4% of those treated with reconstruction and 33.3% of those who had an
amputation) were rehospitalized between two and seven years after the
injury.
An examination of the distribution of SIP scores at eighty-four months
after the injury indicated that only 34.5% of the overall population (all
treatment groups) had a physical SIP subscore typical of the general
population (<5 points); one-half (49.4%) had a physical SIP subscore of
=10 points (indicative of severe disability), and more than one-quarter
(26.5%) had a physical SIP subscore of =20 points (indicative of very
severe disability) (Table III).
The percentage of patients with a score of <5 points on the psychosocial
SIP subscale (50.1%) was higher than the percentage with such a score on the
physical SIP subscale, and the percentages with psychosocial SIP subscores
indicating severe and very severe disability (13.1% and 23.4%, respectively)
were lower than the percentages with physical SIP subscores indicating such
disability (Table IV).
After we controlled for important injury and patient characteristics, there
were few significant differences in outcomes between the treatment groups,
with two exceptions (Table V).
When compared with patients treated with a reconstruction for a tibial shaft
fracture, those with only a severe soft-tissue leg injury (severe crush
injury, degloving injury, or major avulsion) were 3.1 times more likely to
have a physical SIP subscore of 5 points at eighty-four months (p < 0.05)
and those who underwent a through-the-knee amputation were 11.5 times more
likely to have such a subscore at eighty-four months (p < 0.05). It is
interesting to note that the risk of a very severe disability (a physical SIP
subscore of =20 points) at eighty-four months was not significantly
different among the treatment groups. Patients who undergo a foot amputation
appear to be at increased risk for very poor outcomes; 57.2% had a physical
SIP score of =20 points, and after we adjusted for covariates they were 4.5
times more likely to have a physical SIP subscore of =20 points at
eighty-four months. However, these differences were not significant, most
likely because of the small number of these patients in the study. There were
no significant differences in psychosocial outcomes among the treatment
groups.
Patient characteristics that were significantly associated with poorer
outcomes at eighty-four months included older age, female gender (for physical
functioning only), 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 for the
purpose of obtaining disability payments (for psychosocial functioning
only).
The results of this seven-year follow-up study of the LEAP cohort
confirm the results that had been obtained at two
years10,28.
Specifically, there were few differences in SIP outcomes among the treatment
groups, with a couple of notable exceptions. Patients who underwent a
through-the-knee amputation remained at the highest risk for an overall poor
outcome. As discussed with respect to the two-year
outcomes28, the
poor seven-year outcomes following through-the-knee amputation (especially as
compared with those following above-the-knee amputation) were most likely due
to the fact that through-the-knee amputations following a traumatic injury are
typically performed when the knee is included in the zone of injury and a long
posterior flap containing the gastrocnemius muscle is often not available.
These seven-year results further underscore the importance of critically
evaluating the need for a through-the-knee amputation in a patient who has
sustained lower-limb trauma.
Contrary to our hypothesis that outcomes would continue to improve beyond
two years, we found that both physical and psychosocial function, as measured
with the SIP, deteriorated over time. On the average, the physical SIP
subscore increased by 4.4 points and the psychosocial SIP subscore, by 3.4
points. Although, as discussed further below, the change in the mode of
administration of the SIP (in person by an investigator at twenty-four months
compared with by telephone at eighty-four months) may account for some of this
difference, it is unlikely to explain all of the difference. The increase in
SIP scores was probably due, at least in part, to the aging of the cohort. By
seven years after the injury, 41% of the LEAP patients were older than
forty-five years of age, 17% were older than fifty-five, and 6% were older
than sixty-five. It is well known that, in general, physical function worsens
with age29. This
explanation for the observed decrease in function is bolstered by the finding
that increasing age was associated with increasing odds of poor outcomes at
eighty-four months. No significant age effect was noted in the analysis of the
two-year outcomes. This worsening of the SIP scores between two and seven
years following the trauma may also reflect the emergence of secondary
conditions, such as arthritis and chronic pain, often associated with both
amputation and limb reconstruction. Unfortunately, a clinical examination at
seven years to confirm these diagnoses was beyond the scope of this study.
Overall, the long-term functional outcomes were poor in this cohort of
patients. Some patients do, however, achieve better outcomes than others.
Specifically, men, individuals who are younger at the time of the injury, and
those with a higher socioeconomic status as measured by both education and
poverty status had better long-term outcomes. Those who, at the time of the
injury, reported that they had never smoked also had better outcomes. Except
for age, all of these factors were also important predictors of outcome at two
years. Involvement with the legal system for the purpose of obtaining
disability payments was a significant determinant of outcome at two years but
was less important in explaining variations in physical functioning at seven
years. However, it remained a predictor of poor long-term psychosocial
function.
This study also confirms the importance of self-efficacy in long-term
recovery following major limb trauma. Self-efficacy refers to a person's
confidence about being able to perform specific tasks or activities. Persons
with low self-efficacy are more likely to disengage from the coping process
because they expect failure. In studies of patients with chronic pain,
self-efficacy has been found to mediate the relationship among pain intensity,
disability, and
depression30,31.
Self-efficacy can be both taught and improved, and modification of
self-efficacy through cognitive-behavioral interventions has been
demonstrated32.
More research is needed to develop and evaluate similar programs for
individuals recovering from major limb trauma.
This analysis provides one of the first long-term, prospective assessments
of outcome following major limb trauma. The study has many strengths,
including its prospective design; the inclusion of multiple centers, which
increases the generalizability of the results; and the use of previously
validated, widely used measures of both outcomes and risk factors.
Characteristics of the injury, its treatment, and the patient were delineated
in detail and incorporated into a comprehensive outcome-prediction model.
As is the case with any observational study, our investigation had
limitations, which must be taken into account when the results are
interpreted. Although, to our knowledge, we conducted the largest prospective
study of outcomes following major limb trauma, the numbers preclude important
subgroup analysis. The follow-up rates at seven years were respectable,
although complete data were missing for 27% of the patients who had been
initially enrolled in the study. Patients with missing data tend to be of
lower socioeconomic status, suggesting that our results regarding poor overall
levels of functional recovery may actually underestimate the full extent of
the problem. It is important to note, however, that there were no significant
differences in attrition according to the type of treatment. Perhaps the most
important limitation of the study is that the results are not generalizable
beyond level-I trauma centers. The clinical outcomes that were observed in
this study, especially following the reconstructions, may well be better than
average, given the injury volume and experience of the participating clinical
centers. Finally, the SIP outcomes were assessed in person by an investigator
at two years and by telephone at seven years. Although there is evidence to
suggest that people report fewer health symptoms by telephone than by
mail33, the
differences in responses between telephone and in-person interviews are less
clear34.
These long-term results confirm our previous conclusions that efforts to
improve the rate of successful reconstructions have merit. Given the
equivalent long-term outcomes found in this study, the reconstruction of a
severely injured extremity below the distal part of the femur is a reasonable
goal at an experienced level-I trauma center. Regardless of the treatment
option, however, long-term functional outcomes are poor, underscoring the
major public-health impact of major limb trauma. Priority should be given to
efforts to improve post-acute-care services that address secondary conditions
that compromise optimal recovery and clinical interventions that can reduce
limb complications and the need for hospital readmission. ?
Note: The authors acknowledge the efforts of the
co-investigators, study coordinators, and physical therapists at each of the
eight LEAP study sites, which were essential to the success of the study. They
include Julie Agel, ATC; Jennifer Avery, PT; Denise Bailey, PT; Wendall Bryan;
Debbie Bullard; Carla Carpenter, PT; Elizabeth Chaparro, RN; Kate Corbin;
Denise Darnell, RN, BSN; Stephaine Dickason, PT; Thomas DiPasquale, DO; Betty
Harkin, PT; Michael Harrington, PT; Dolfi Herscovici, DO; Amy Holdren, RNC,
ANP, MSN; Linda Howard, PT; Sarah Hutchings, BS; Marie Johnson, LPN; Melissa
Jurewicz, PT; Donna Lampke, PT; Karen Lee, RN; Marianne Mars, PT; Maxine
Mendoza-Welch, PA; J. Wayne Meredith, MD; Nan Morris, PT; Karen Murdock, PT;
Pat Radey, RN; Sandy Shelton, PT; Sherry Simpson, PT; Steven Sims, MD; Celia
Wiegman, RN; John Wilber, MD; Stephanie Williams, PA; Philip Wolinsky, MD;
Mary Woodman, BA; and Michele Zimmerman, RN.
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