Michael J. Bosse

Recombinant human BMP-2 and allograft compared with autogenous bone graft for reconstruction of diaphyseal tibial fractures with cortical defects : A randomized, controlled trial

BACKGROUND Currently, the treatment of diaphyseal tibial fractures associated with substantial bone loss often involves autogenous bone-grafting as part of a staged reconstruction. Although this technique results in high healing rates, the donor-site morbidity and potentially limited supply of suitable autogenous bone in some patients are commonly recognized drawbacks. The purpose of the present study was to investigate the benefit and safety of the osteoinductive protein recombinant human bone morphogenetic protein-2 (rhBMP-2) when implanted on an absorbable collagen sponge in combination with freeze-dried cancellous allograft. METHODS Adult patients with a tibial diaphyseal fracture and a residual cortical defect were randomly assigned to receive either autogenous bone graft or allograft (cancellous bone chips) for staged reconstruction of the tibial defect. Patients in the allograft group also received an onlay application of rhBMP-2 on an absorbable collagen sponge. The clinical evaluation of fracture-healing included an assessment of pain with full weight-bearing and fracture-site tenderness. The Short Musculoskeletal Function Assessment (SMFA) was administered before and after treatment. Radiographs were used to document union, the presence of extracortical bridging callus, and incorporation of the bone-graft material. RESULTS Fifteen patients were enrolled in each group. The mean length of the defect was 4 cm (range, 1 to 7 cm). Ten patients in the autograft group and thirteen patients in the rhBMP-2/allograft group had healing without further intervention. The mean estimated blood loss was significantly less in the rhBMP-2/allograft group. Improvement in the SMFA scores was comparable between the groups. No patient in the rhBMP-2/allograft group had development of antibodies to BMP-2; one patient had development of transient antibodies to bovine type-I collagen. CONCLUSIONS The present study suggests that rhBMP-2/allograft is safe and as effective as traditional autogenous bone-grafting for the treatment of tibial fractures associated with extensive traumatic diaphyseal bone loss. LEVEL OF EVIDENCE Therapeutic Level II. See Instructions to Authors for a complete description of levels of evidence.

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.

Adult respiratory distress syndrome, pneumonia, and mortality following thoracic Injury and a femoral fracture treated either with intramedullary nailing with reaming or with a plate : A comparative study

Multiply injured patients (an Injury Severity Score of 17 points or more) who were admitted to one of two level-I regional trauma centers between 1983 and 1994 because of a fracture of the femoral shaft with a thoracic injury (an Abbreviated Injury Scale score of 2 points or more) or without a thoracic injury were studied retrospectively. The patient populations and the protocols for the treatment of trauma were similar at the two centers; however, the centers differed with regard to the technique that was used for acute stabilization of the fracture of the femoral shaft. At Center I intramedullary nailing with reaming was used in 217 (95 per cent) of the 229 patients, whereas at Center II a plate was used in 206 (92 per cent) of the 224 patients. This difference was used to investigate the effect of acute femoral reaming on the occurrence of adult respiratory distress syndrome in multiply injured patients who had a chest injury. Three groups of patients were evaluated: those who had both a fracture of the femur and a thoracic injury, those who had a fracture of the femur but no thoracic injury, and those who had a thoracic injury without a fracture of the femur or the tibia. The third group was studied at each center to determine if there was a difference between the institutions with regard to the rate of adult respiratory distress syndrome. Patients who had diabetes, chronic obstructive pulmonary disease, asthma, hepatic or renal failure, or an immunosuppressive condition were excluded from the study. The records were abstracted to determine the Injury Severity Score, Abbreviated Injury Scale score, and Glasgow Coma Score for each patient. Requirements for fluid resuscitation were calculated for the first twenty-four hours; these included the number of units of packed red blood cells, fresh-frozen plasma, and platelets that were transfused and the volume of crystalloid that was used. The duration of intubation, the duration of hospitalization, and the occurence of adverse outcomes (death, multiple organ failure, adult respiratory distress syndrome, pneumonia, and pulmonary embolism) were determined for each patient. The groups of patients were analyzed as a whole and then were stratified into subgroups (according to whether or not they had a thoracic injury and whether the Injury Severity Score was less than 30 points or 30 points or more) to determine if the type of fixation of the femoral fracture affected the rate of adult respiratory distress syndrome or mortality. Logistic regression models were used to analyze the data. The over-all occurrence of adult respiratory distress syndrome in the 453 patients who had a femoral fracture was only 2 per cent (ten patients). The rates of adult respiratory distress syndrome for the patients who had a thoracic injury but no femoral fracture (eight [6 per cent] of 129 patients at Center I, compared with ten [8 per cent] of 125 patients at Center II) did not differ between centers, suggesting that the institutions were comparable in their treatment of multiply injured patients. The occurrence of adult respiratory distress syndrome in the patients who had a femoral fracture without a thoracic injury did not differ substantially according to whether the fracture had been treated with a nail (118 patients) or a plate (114 patients). Likewise, the frequency of adult respiratory distress syndrome, pneumonia, pulmonary embolism, failure of multiple organs, or death for the patients who had a femoral fracture and a thoracic injury was similar regardless of whether nailing with reaming (117 patients) or a plate (104 patients) had been used. The use of intramedullary nailing with reaming for acute stabilization of fractures of the femur in multiply injured patients who have a thoracic injury without a major comorbid disease does not appear to increase the occurrence of adult respiratory distress syndrome, pulmonary embolism, failure of multiple organs, pneumonia, or death.

Psychological Distress Associated with Severe Lower-Limb Injury

BACKGROUND Little is known about the psychological morbidity associated with limb-threatening injuries. It was hypothesized that a substantial proportion of patients who sustain a severe lower-limb injury will report serious psychological distress. METHODS Adult patients who were admitted to one of eight level-I trauma centers for treatment of an injury threatening the lower limb were enrolled during their initial hospitalization. Patients were recontacted at three, six, twelve, and twenty-four months after the injury and asked to complete the Brief Symptom Inventory (BSI), a fifty-three-item, self-reported measure of psychological distress. Patients who screen positive on the BSI are considered likely to have a psychological disorder and should receive a mental health evaluation. Longitudinal regression techniques were used to model positive case status (i.e., likely to have a psychological disorder) as a function of patient, injury, and treatment characteristics. RESULTS Of the 569 patients enrolled, 545 (96%) completed at least one BSI and 385 (68%) completed all four. Forty-eight percent of the patients screened positive for a likely psychological disorder at three months after the injury, and this percentage remained high (42%) at twenty-four months. Two years after the injury, almost one-fifth of the patients reported severe phobic anxiety and/or depression. While these two subscales reflected the highest prevalence of severe psychological distress, none of the BSI subscales reflected the prevalence expected from a normal sample (i.e., 2% to 3%). Factors associated with a likely psychological disorder included poorer physical function, younger age, non-white race, poverty, a likely drinking problem, neuroticism, a poor sense of self-efficacy, and limited social support. Relatively few patients reported receiving any mental health services following the injury (12% at three months and 22% at twenty-four months). CONCLUSIONS Severe lower-limb injury is associated with considerable psychological distress. More attention to the psychological as well as the physical health of patients who sustain a limb-threatening injury may be needed to ensure an optimal recovery following these devastating injuries.

Health-care costs associated with amputation or reconstruction of a limb-threatening injury

BACKGROUND Recent reports have suggested that functional outcomes are similar following either amputation or reconstruction of a severely injured lower extremity. The goal of this study was to compare two-year direct health-care costs and projected lifetime health-care costs associated with these two treatment pathways. METHODS Two-year health-care costs were estimated for 545 patients with a unilateral limb-threatening lower-extremity injury treated at one of eight level-I trauma centers. Included in the calculation were costs related to (1) the initial hospitalization, (2) all rehospitalizations for acute care related to the limb injury, (3) inpatient rehabilitation, (4) outpatient doctor visits, (5) outpatient physical and occupational therapy, and (6) purchase and maintenance of prosthetic devices. All dollar figures were inflated to constant 2002 dollars with use of the medical service Consumer Price Index. To estimate projected lifetime costs, the number of expected life years was multiplied by an estimate of future annual health-care costs and added to an estimate of future costs associated with the purchase and maintenance of prosthetic devices. RESULTS When costs associated with rehospitalizations and post-acute care were added to the cost of the initial hospitalization, the two-year costs for reconstruction and amputation were similar. When prosthesis-related costs were added, there was a substantial difference between the two groups (

Functional Outcomes Following Trauma-Related Lower-Extremity Amputation

81,316 for patients treated with reconstruction and

Factors influencing the decision to amputate or reconstruct after high-energy lower extremity trauma

91,106 for patients treated with amputation). The projected lifetime health-care cost for the patients who had undergone amputation was three times higher than that for those treated with reconstruction (

Complications Following Limb-threatening Lower Extremity Trauma

509,275 and