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Controversy exists regarding management of proximal tibial metaphyseal fractures with severe soft tissue injury. It is unclear whether limb salvage or early amputation results in the best functional and clinical outcomes.
We hypothesized that in this group of patients, there is no difference in functional outcomes, complication rates, clinical outcomes, or objective physical function related to the treatment approach.
We used the LEAP study database to perform a retrospective comparative review of a subset of patients with proximal tibial metaphyseal fractures (AO/OTA 41A, B, and C) with associated severe soft tissue injuries comparing the outcomes of patients who were treated with either limb salvage or amputation.
Although there were major differences in clinical and functional outcomes based on patients’ sociodemographics at 2 years, no differences in clinical or functional outcomes were detected regardless of whether amputation or limb salvage was performed. Severity of soft tissue injury was more predictive of outcome than the surgical approach used.
Sociodemographics and soft tissue injury severity are more important than treatment approach for predicting clinical and functional outcomes at 2 years in patients with proximal tibia metaphyseal fractures with severe soft tissue injury.
Level III, retrospective comparative study. See Guidelines for Authors for a complete description of levels of evidence.
Proximal tibial metaphyseal fractures (AO/OTA classification 41), including extraarticular (41A) and intraarticular fractures (41B, C) associated with severe soft tissue injury (Gustilo-Anderson Grades IIIA, B, C), pose a treatment dilemma for the surgeon and a high incidence of complications for the patient [17, 19]. Specifically, a decision must be made regarding whether to pursue early amputation or to attempt limb salvage [5, 8, 10, 14].
Two prospective studies of treatment of extremity fractures below the distal femur with associated severe soft tissue injury have suggested that for these patients, long-term functional outcomes are relatively similar for amputation and limb salvage [3, 12]. However, no previous study specifically has evaluated the treatment outcomes of proximal tibial metaphyseal fractures with associated severe soft tissue injuries, and controversy remains regarding whether amputation or salvage produces better long-term clinical and functional outcomes .
Among patients undergoing limb salvage, additional controversy exists regarding the importance of obtaining a precise anatomic articular reduction and whether different methods of stabilization (ie, external fixation versus plate fixation) result in superior clinical and functional outcomes or a reduced complication rate . Commonly encountered complications include infection, range of motion (ROM) deficits, malunion, loss of fixation, and soft tissue compromise. In some cases, these may lead to delayed amputation and considerable additional morbidity for the patient.
The Lower Extremity Assessment Project (LEAP) is a multicenter, prospective outcomes study that includes patients who sustained a high-energy lower extremity injury . The study relies on existing variations in treatment of severe limb-threatening injuries across eight Level I trauma centers to examine differences in treatment decisions and outcomes . The LEAP study database offers an opportunity for a retrospective comparative review of a subset of patients with proximal tibial metaphyseal fractures (AO/OTA 41A, B, and C) with associated severe soft tissue injuries.
The primary aim of our study was to determine whether salvage or amputation results in superior clinical and functional outcomes 2 years after treatment in patients with severe soft tissue injuries associated with a proximal tibial metaphyseal fracture. We hypothesized that salvage and amputation would result in equivalent outcomes with respect to long-term functional outcomes (Sickness Impact Profile [SIP] scores, return to work), complications (reoperation, infection, nonunion, osteomyelitis), clinical outcomes (time to union, procedures to union, bone grafts, total procedures), and objective physical function (strength, ROM, timed walking distance test),. Our second aim was to determine whether external fixation or plate fixation (among patients who undergo salvage) results in a lower complication rate (infection, nonunion, osteomyelitis) and better clinical outcomes (time to fracture union, procedures to union). We hypothesized there is no difference in these outcomes as a result of the chosen fixation method.
The LEAP Study consists of eight Level I trauma centers that prospectively enrolled 656 patients aged 18 to 69 years with severe soft tissue injuries associated with lower extremity fractures between 1994 and 1997 . Patients were excluded if they had a Glasgow Coma Score less than 15 at 21 days postinjury, a spinal cord deficit, prior amputation, presented more than 24 hours after injury, did not speak English or Spanish, had a documented psychiatric disorder, or were on active military duty. The study was approved by the Institutional Review Board at the coordinating center and at each study site. Informed written consent was obtained from all study participants.
Our study is a retrospective cross-sectional comparison of two subsets of patients originally enrolled by the LEAP Study. Five hundred sixty-nine of the originally enrolled patients were available for review at 24 months followup. In this group, there were 38 patients with proximal tibial fractures who met the AO/OTA classification for proximal end segment fractures with open soft tissue injury (3A = 10, 3B = 20, 3C = 8) who completed a limb salvage protocol (SAL). Among this subset 29 patients had intraarticular (41B, C) and nine had extraarticular (41A) fractures. An additional 22 patients with proximal end segment fractures (17 intraarticular [41B, C] and five extraarticular [41A]) with open soft tissue injury (3A = 0, 3B = 14, 3C = 8) underwent early amputation (AMP), which was defined as any amputation occurring within the first 3 months of the initial injury. There were five below-knee amputations, five through-knee amputations, and 12 above-knee amputations.
Prospective examinations of all patients at 3, 6, 12, and 24 months were completed. To assess functional outcomes, a record was made of whether the patient had returned to work (RTW), and SIP scores were calculated. This included the physical SIP, psychosocial SIP, and overall SIP. The SIP is a multidimensional measure of self-reported health status and consists of 136 statements about limitations in 12 categories of function: ambulation, mobility, body care and movement, social interaction, alertness, emotional behavior, communication, sleep and rest, eating, work, home management, and recreation . Scores are computed for each of the 12 categories and two overall categories, physical and psychosocial health. These outcome measures have been well validated, and it is known that a score of 2 to 3 indicates meaningful limitations in function with scores greater than 10 indicating severe disability [6, 9, 13, 15]. To assess complications, a record was made of any infections, nonunion, osteomyelitis, or reoperations. Clinical measures were recorded, including time to union, number of procedures to attain union, number of bone grafts required, and total procedures completed during the study period. Finally, objective measurements of physical function included an assessment of ROM, strength of the affected extremity, and a timed walking distance test.
Basic sociodemographic characteristics were obtained and compared for the AMP and SAL groups, including age, gender, insurance status, education level, poverty status, and ethnicity. Injury characteristics likewise were compared, including Gustilo and Anderson grade of soft tissue injury, amount of bone loss, degree of muscle damage, skin defect circumference, injury severity score (ISS), degree of wound contamination, presence or absence of nerve injury, and presence or absence of compartment syndrome. Treatment characteristics for both study groups also were recorded. For the AMP group, amputation level and myodesis or myoplasty were noted. For the SAL group, final fracture stabilization method and time to bone grafting were recorded. None of the patients in the SAL group progressed to amputation during the study period. Finally, for both groups, the following were recorded: number of débridements, soft tissue coverage type, need for vascular repair, need for fasciotomy, time to first débridement, and time to soft tissue coverage.
For each sociodemographic, injury, and treatment characteristic, the average physical SIP was calculated along with the percent with major complications and percent RTW. A major complication was defined as those requiring an additional admission to the hospital. A multivariate regression analysis statistical technique was used to identify any statistically significant differences between the groups with significance defined as p ≤ 0.05.
Next, 2-year outcome data were assessed according to treatment group (SAL, AMP). Two-year functional outcomes included the overall SIP, the physical SIP, the psychosocial SIP, and percent RTW. Two-year treatment complications were compared based on percent with major complications, percent with nonunion, percent with osteomyelitis, and percent with infections. Two-year clinical outcomes were compared, including time to fracture union, number of procedures required to achieve union, number of bone grafts required, and number of surgeries completed during followup (24 months). Finally, 2-year physical therapist-reported outcomes were compared between groups, including percent of patients with walking speed greater than 4 feet per second, American Medical Association (AMA) percent impairment of strength, and AMA percent impairment of ROM. Statistical comparisons were completed with significance defined as p ≤ 0.05.
In the SAL group, an additional analysis was completed to compare outcomes with external fixation and plate fixation. Specific variables compared included overall complications (infections, nonunions, osteomyelitis), time to fracture union, and number of procedures to achieve union. Statistical significance was defined by p ≤ 0.05.
There were no major differences in the distribution of patients’ ages, gender, insurance status, education level, poverty status, or ethnicity between the study populations; however, several sociodemographics were significantly related to outcomes (Table 1). For SAL, physical SIP scores were lower in patients 34 years and younger versus 35 years and older (p = 0.05). Patients in the SAL group with a college education had lower physical SIP scores (p = 0.031) as did patients in the AMP group who were scored as nonpoor (p = 0.018). In both groups, there was a significant difference in percent RTW based on education level with patients with a college education more likely to return to work (p = 0.004, p = 0.008). Both groups had similar results with respect to each injury category, and the only statistically significant difference was a higher physical SIP among amputees with an ISS greater than 13 (p = 0.05) (Table 2). With respect to the treatment characteristics of the AMP group, myoplasty (p = 0.018) and fasciotomy (p = 0.037) were associated with a significantly higher physical SIP but no difference in major complications or RTW (Table 3). Amputation level, number of débridements, soft tissue coverage, vascular repair, time to first débridement, and time to soft tissue coverage were not significantly associated with physical SIP, major complications, or RTW. For the SAL group, final fracture stabilization method, débridements, soft tissue coverage, vascular repair, fasciotomy, time to first débridement, time to soft tissue coverage, and timing of bone graft had no significant association to physical SIP, major complications, or RTW (Table 4).
Two-year outcomes data showed no major differences between AMP and SAL. There were no statistical differences among the functional outcomes, including overall SIP, physical SIP, psychosocial SIP indices, and percent RTW (Table 5). Complications during the 2-year period were prevalent in both treatment groups with no significant differences between SAL and AMP, although there was a trend toward more major complications and nonunions in the SAL group (p = 0.088, p = 0.055) (Table 6). Among clinical outcomes, patients in the SAL group underwent significantly more bone graft and overall procedures than patients in the AMP group during the followup period (p = 0.0003, p = 0.0005) (Table 7). Finally, comparing physical therapist-reported outcomes, the SAL group was able to walk faster than the AMP group (p = 0.039) (Table 8).
Comparing different fixation methods among patients undergoing SAL (external fixation to plate stabilization), no significant differences were noted. It appeared the percent nonunion rate was less with plate fixation (p < 0.15), although the plate fixation group had a slightly higher infection rate. The only other apparent trend was the number of procedures to achieve union, which was less for plate fixation compared with external fixation (p < 0.15).
Controversy persists regarding whether amputation or salvage produces a better outcome for patients with proximal end segment tibial metaphyseal fractures with severe soft tissue injury [4, 5, 7, 8, 16]. We hypothesized that for this subset of patients, functional outcomes, complications, clinical outcomes, and objective functional outcomes are equivalent for salvage and amputation. Furthermore, it was hypothesized that outcomes for salvaged limbs are not significantly affected based on the choice between plate fixation and external fixation.
Our study has important limitations that must be acknowledged. As noted, our patients were not assigned randomly to either amputation or salvage, and therefore, it is possible some bias resulted from individual surgeons choosing the treatment plan. The AMP group had more patients with substantial wound contamination and a higher percent of patients with Gustilo and Anderson Grades IIIB and IIIC soft tissue injuries. The statistical methods we used attempted to minimize this factor; however, the possibility of a residual bias cannot be ignored. In addition, it is unclear whether these results would be generalizable beyond a Level I trauma center, because the individual expertise of the surgeons at Level I centers in treating these injuries may not match the skill set of the general community orthopaedic surgeon. Finally, outcomes at 24 months postinjury are presented in this study, and although related studies suggest this is a valid measurement of long-term (5+ year) outcomes for this population , it remains possible that salvage may have better 5- or 10-year outcomes as compared with amputation or vice versa.
Although there were significant differences in clinical and functional outcomes based on patients’ sociodemographics at 2 years, our results were consistent with our hypothesis that clinical and functional outcomes from these injuries are equivalent in most respects regardless of the treatment approach. A previous meta-analysis of 1300 patients after Grades IIIB and IIIC injuries of the tibia showed a 64% RTW rate for patients who had a salvage procedure and a 73% RTW rate for patients who had an amputation . In our study, similar results were observed with only 50% to 60% of patients returning to work during the followup period in both groups. Patients in both treatment groups in the current study also had similar residual functional limitations at 2 years postinjury as well based on SIP data. This was consistent with the conclusions reached by the original LEAP study, which included a more general population with limb-threatening traumatic injuries below the distal femur . Additional followup from the patients in that study showed clinical and functional results did not significantly improve with time beyond the 2-year followup. In fact, average functional outcomes for patients who had salvage procedures and patients who had amputations continued to deteriorate between 24 and 84 months . Therefore it may be inferred that similar limitations are faced by the current study population. The remaining differences between SAL and AMP in the current cohort echoed previously reported results as well with a clear trend toward more complications and more overall procedures in patients who had limb salvage .
Our analysis of method of fixation for the salvage group was limited by the relatively small number of subjects but did not show any significant differences between external fixation and plate fixation. There was a trend toward increased risk of infection with plate fixation compared with external fixation, but also a lower risk of nonunion and the need for additional procedures (p < 0.15). These findings may be worthy of additional study in a larger patient population.
It is concluded from this review of severe soft tissue injuries associated with proximal, tibial end segment fractures (AO/OTA 41) that there are no significant differences between functional and clinical outcomes of salvage and early amputation at 2 years postinjury; however, overall function and objective outcomes generally are below normal levels.
The LEAP Study Group: Ellen J. MacKenzie PhD, Michael J. Bosse MD, Andrew R. Burgess MD, Renan C. Castillo PhD, Alan L. Jones MD, James F. Kellam MD, Mark P. McAndrew MD, Melissa L. McCarthy ScD, Brendan Patterson MD, Roy Sanders MD, Douglas G. Smith MD, Adam Starr MD, Marc F. Swiontkowski MD, Thomas G. Travison PhD, Lawrence X. Webb MD.
One or more of the authors (RCC, MJB, EJM) received funding from NIH-NIAMS (RO1-AR42659).
Each author certifies that his or her institution approved the human protocol for this investigation, that all investigations were conducted in conformity with ethical principles of research, and that informed consent for participation in the study was obtained.
This work was performed at Carolinas Medical Center, Charlotte, NC, USA, with study data collected from eight institutions.