Clinical Outcomes of Nonunions of Hindfoot and Ankle Fusions.

BACKGROUND: While nonunion after foot and ankle fusion surgery has been associated with poor outcomes, we are not aware of any longitudinal study on this subject. Thus, we prospectively evaluated the impact of nonunion on clinical outcomes of foot and ankle fusions and identified potential risk factors for nonunion after these procedures. METHODS: Using data from a randomized clinical trial on recombinant human platelet-derived growth factor-BB (rhPDGF-BB; Augment Bone Graft, BioMimetic Therapeutics), union was defined either by assessment of computed tomography (CT) scans at 24 weeks by a reviewer blinded to the type of treatment or by the surgeon's composite assessment of clinical and radiographic findings at 52 weeks and CT findings at 24 or 36 weeks. The nonunion and union groups (defined with each assessment) were then compared in terms of clinical outcome scores on the American Orthopaedic Foot & Ankle Society Ankle-Hindfoot Scale (AOFAS-AHS), Foot Function Index (FFI), and Short Form-12 (SF-12) as well as age, sex, body mass index (BMI), smoking status, diabetes status, work status, and arthrodesis site. RESULTS: Blinded CT assessment identified nonunion in 67 (18%) of 370 patients, and surgeon assessment found nonunion in 21 (5%) of 389 patients. Postoperatively, the nonunion group scored worse than the union group, regardless of the method used to define the nonunion, on the AOFAS-AHS and FFI, with mean differences of 10 and 12 points, respectively, when nonunion was determined by blinded CT assessment and 19 and 20 points when it was assessed by the surgeon. The nonunion group also had worse SF-12 Physical Component Summary scores. Differences between the union and nonunion groups were clinically meaningful for all outcome measures, regardless of the nonunion assessment method. The concept of an asymptomatic nonunion (i.e., imaging indicating nonunion but the patient doing well) was not supported. Patients with nonunion were more likely to be overweight, smokers, and not working. CONCLUSIONS: This prospective longitudinal study demonstrated poorer functional outcomes in patients with a nonunion after foot and ankle fusion, regardless of whether the diagnosis of nonunion was based on CT only or on combined clinical, radiographic, and CT assessment. LEVEL OF EVIDENCE: Prognostic Level III. See Instructions for Authors for a complete description of levels of evidence.

Does autogenous bone graft work? A logistic regression analysis of data from 159 papers in the foot and ankle literature.

BACKGROUND: While autogenous cancellous iliac crest bone graft is the gold standard for foot and ankle surgery, it lacks Level I evidence. Although one third of all graft cases performed in the United States today rely on allograft, some surgeons believe no graft is necessary. We hypothesized that a systematic review of the foot and ankle literature would reveal that (1) autogenous bone graft during foot and ankle arthrodesis would demonstrate healing rates that were superior to the use of either using allograft or no bone graft at all, and (2) these differences would be even more dramatic in patients having risk factors that impair bone healing. To our knowledge, neither of these assessments to date has ever been performed with this body of literature. The goal of this study was to review the use and union rates of bone graft during foot and ankle arthrodesis and determine if autogenous bone graft was superior. METHODS: A literature search was performed to include articles between 1959 and 2012 using autograft, allograft, and/or no bone graft for foot and/or ankle arthrodesis. Case reports involving fewer than four patients, investigations failing to incorporate outcome data, those involving orthobiologic augmentation, and those including vascularized graft, xenograft, or pediatric patients were excluded. Recorded search results included patient demographics, comorbidities, pre-operative diagnosis, surgical procedure, bone graft type and indication, union rate, method of fixation, patient satisfaction, all outcome scores, definition of healing/success, and any listed complications including revision. Final data were stratified based upon the type of graft material. RESULTS: This search generated 953 related articles, of which 159 studies (5327 patients) met inclusion criteria. The majority (153/159) were retrospective case series. Systematic review demonstrated a trend toward higher union rates for cancellous autograft (OR 1.39, p=0.11), structural autograft (OR 1.52, p=0.09), and cancellous allograft (OR 1.31, p=0.52) relative to no graft material, but none reached statistical significance. Compared to no graft, structural allograft trended toward worse performance (OR 0.62, p=0.17). The overall probability of union was 93.7% for cancellous autograft, 94.2% for structural autograft, 93.3% for cancellous allograft, 91.4% for no graft, and 86.9% for structural allograft. When only comparing the 19 papers that included a no graft arm (91.9% union rate), data revealed the highest union using cancellous autograft (95.1%, OR 1.73, p=0.09) and structural autograft (96.3%, OR 2.33, p=0.06) while only 76% for structural allograft. No significant statistical association existed between union rates and other recorded variables. CONCLUSION: Systematic analysis of bone graft use in foot and ankle fusions favors the use of autograft and cancellous allograft for optimized healing rates, although no differences were statistically significant. If we assume that graft material been chosen for more complex procedures having lower anticipated union rates, then these data lend further support to the use of autograft and cancellous allograft. LEVEL OF EVIDENCE: Level IV.

Survey on the need for bone graft in foot and ankle fusion surgery.

BACKGROUND: Generally, autologous bone graft is felt to be an important treatment adjunct in the presence of structural deformity, surface irregularities, defects (due to trauma, surgery, or degenerative changes), or underlying comorbidities that predispose the patient to healing challenges. This study assessed the prognostic and predictive factors used in the clinical decision making for bone graft supplementation in foot and ankle fusion surgery. METHODS: Utilizing standard survey research methodology, key-informant interviews, pretesting, and pilot testing; a survey was constructed. The survey consisted of a web-based 5-point Likert-type scale (never, seldom, sometimes, almost always, always) listing 14 clinical and 11 radiologic criteria that may influence the use of autologous bone grafting or other biologic augmentation in foot and ankle surgery. This survey was sent to Orthopaedic Foot and Ankle Surgeons in North America and Canada. RESULTS: A total of 48 foot and ankle surgeons completed the blinded survey (73% response rate). More than 70% of responders felt bone graft was almost always (AA) or always (A) indicated in prior nonunion of the indicated joint (96%). Fewer than 50% of respondents felt poor soft tissue integrity (20%), prior foot and ankle infection (20%), and current foot and ankle infection (4%) needed bone graft. Radiologic factors marked as AA or A in over 70% of responders include radiographic evidence of nonunion (96%), avascular necrosis (87%), and others. Factors chosen as AA or A by fewer than 50% of surgeons include prior adjacent joint fusions (47%), intra-articular deformity (31%), and extra-articular deformity (13%). CONCLUSIONS: There was some uniformity of agreement on the number of both clinical and radiologic factors that prompt a surgeon to utilize autologous bone graft to try to avoid the complication of nonunion. Surgeons may wish to consider these factors when making a decision on the use of bone graft to supplement fusion.

Hepatitis B and hepatitis C in Pakistan: prevalence and risk factors.

BACKGROUND: Pakistan carries one of the world's highest burdens of chronic hepatitis and mortality due to liver failure and hepatocellular carcinomas. However, national level estimates of the prevalence of and risk factors for hepatitis B and hepatitis C are currently not available. METHODS: We reviewed the medical and public health literature over a 13-year period (January 1994-September 2007) to estimate the prevalence of active hepatitis B and chronic hepatitis C in Pakistan, analyzing data separately for the general and high-risk populations and for each of the four provinces. We included 84 publications with 139 studies (42 studies had two or more sub-studies). RESULTS: Methodological differences in studies made it inappropriate to conduct a formal meta-analysis to determine accurate national prevalence estimates, but we estimated the likely range of prevalence in different population sub-groups. A weighted average of hepatitis B antigen prevalence in pediatric populations was 2.4% (range 1.7-5.5%) and for hepatitis C antibody was 2.1% (range 0.4-5.4%). A weighted average of hepatitis B antigen prevalence among healthy adults (blood donors and non-donors) was 2.4% (range 1.4-11.0%) and for hepatitis C antibody was 3.0% (range 0.3-31.9%). Rates in the high-risk subgroups were far higher. CONCLUSIONS: Data suggest a moderate to high prevalence of hepatitis B and hepatitis C in different areas of Pakistan. The published literature on the modes of transmission of hepatitis B and hepatitis C in Pakistan implicate contaminated needle use in medical care and drug abuse and unsafe blood and blood product transfusion as the major causal factors.

Tibial artery calcification as a marker of amputation risk in patients with peripheral arterial disease.

OBJECTIVES: The purpose of this study was to evaluate the relationship between calcification in tibial arteries, the degree of limb ischemia, and the near-term risk of amputation. BACKGROUND: Determining the amputation risk in patients with peripheral arterial disease (PAD) remains difficult. Developing new measures to identify patients who are at high risk for amputation would allow for targeted interventions and focused trials aimed at limb preservation. METHODS: Two hundred twenty-nine patients underwent evaluation by history, arterial Doppler, and multislice computed tomography of the lower extremities. We then explored the relationship between a tibial artery calcification (TAC), traditional risk factors for PAD, limb status at presentation, and near-term amputation risk. RESULTS: Increased age and traditional atherosclerosis risk factors were associated with higher TAC scores. Patients with critical limb ischemia had the highest TAC scores, and increasing TAC scores were associated with worsening levels of limb ischemia in ordinal regression analysis. Receiver-operator characteristic analysis suggested that the TAC score predicted amputation better than the ankle-brachial index (ABI). Symptomatic patients with a TAC score greater than 400 had a significantly increased risk of amputation. In Cox regression analysis, there was a strong association between the TAC score and the risk of major amputation that remained after adjustment for traditional risk factors and the ABI. CONCLUSIONS: In patients presenting with PAD, the TAC score is associated with the stage of disease and it identifies those who are at high risk for amputation better than traditional risk factors and an abnormal ABI.

Cost-effective use of breast biopsy techniques in a Veterans health care system.

BACKGROUND: Breast health has become an increasingly important issue among the veteran population. Options for the evaluation of a breast mass or a suspicious mammographic finding include open surgical biopsy at the Veterans Affairs (VA) hospital or percutaneous image-guided biopsy at an affiliated academic institution. We examined the costs and trends in the use of surgical versus percutaneous image-guided biopsy procedures in this diagnostic algorithm. METHODS: A retrospective review was performed of 62 patients who presented to the VA General Surgery Clinic with a breast mass or abnormal mammogram from 2003 to 2005. The Massachusetts Utilization Multiprogramming System and the Decision Support System software packages were used to track costs of procedures, by Current Procedure Terminology code and date of service, performed at the affiliated academic institution and at the VA hospital. These data were analyzed and described using the R statistical computing environment. RESULTS: Forty-six patients were evaluated using open biopsy techniques in the VA operating room, including 8 incisional biopsies, 21 excisional biopsies, and 17 needle-localization excisional biopsies. Sixteen patients were evaluated using minimally invasive biopsies at the affiliated academic institution, including 3 ultrasound-guided cyst aspirations, 6 ultrasound-guided core biopsies/vacuum-assisted core biopsies, 10 stereotactic breast biopsies, and 1 fine-needle aspiration. The average cost to evaluate a breast mass or abnormal mammographic finding in the operating room was 4,368.00 dollars (SD, 2,586.00 dollars), with a median cost of 3,479.00 dollars. The average cost to evaluate a breast mass or mammographic abnormality using percutaneous image-guided procedures was 1,267.00 dollars (SD, 536.00 dollars), with a median of 1,239.00 dollars. From 2003 to 2005, the proportion of percutaneous biopsies increased from 13% to 48%, whereas the proportion of open biopsies decreased from 88% to 52%. CONCLUSIONS: Over a recent 3-year period, we observed a 3.8-fold increase in the use of percutaneous image-guided techniques for the evaluation of breast lesions in the VA Tennessee Valley Healthcare System. Diagnosis by percutaneous techniques allows planning for a definitive surgery if a lesion is malignant or possible avoidance of a surgical intervention if the lesion is benign. Our data show that the costs associated with open biopsy techniques exceed those associated with percutaneous biopsies. For VA hospitals with available resources, the option of image-guided percutaneous biopsy techniques is a cost-effective alternative to open surgical biopsy.

Prevalence of sexual dysfunction among newer antidepressants.

BACKGROUND: Sexual dysfunction commonly occurs during antidepressant treatment. However, the reported rates of sexual dysfunction vary across antidepressants and are typically underreported in product literature. The objectives of this study were (1) to estimate the prevalence of sexual dysfunction among patients taking newer antidepressants (bupropion immediate release [IR], bupropion sustained release [SR], citalopram, fluoxetine, mirtazapine, nefazodone, paroxetine, sertraline, venlafaxine, and venlafaxine extended release [XR]) and (2) to compare physician-perceived with patient-reported prevalence rates of antidepressant-associated sexual dysfunction. METHOD: This cross-sectional, observational study was conducted in 1101 U.S. primary care clinics. Adult outpatients (4534 women and 1763 men) receiving antidepressant monotherapy were enrolled. The prevalence of sexual dysfunction was measured using the Changes in Sexual Functioning Questionnaire. RESULTS: In the overall population, bupropion IR (22%) and SR (25%) and nefazodone (28%) were associated with the lowest risk for sexual dysfunction, whereas selective serotonin reuptake inhibitor (SSRI) antidepressants, mirtazapine, and venlafaxine XR were associated with higher rates (36%-43%). In a prospectively defined subpopulation unlikely to have predisposing factors for sexual dysfunction, the prevalence of sexual dysfunction ranged from 7% to 30%, with the odds of having sexual dysfunction 4 to 6 times greater with SSRIs or venlafaxine XR than with bupropion SR. Physicians consistently underestimated the prevalence of antidepressant-associated sexual dysfunction. CONCLUSION: Ours is the first study to assess sexual dysfunction across the newer antidepressants using consistent methodology and a validated rating scale. Overall, SSRIs and venlafaxine XR were associated with higher rates of sexual dysfunction than bupropion or nefazodone. Because antidepressant-associated sexual dysfunction is considerably underestimated by physicians, greater recognition and education are imperative when prescribing antidepressant treatment.

Continuation phase treatment with bupropion SR effectively decreases the risk for relapse of depression.

BACKGROUND: This was the first controlled continuation phase study (up to 1-year total treatment) to evaluate the safety and efficacy of bupropion SR for decreasing the risk for relapse of depression in patients who responded to bupropion SR. METHODS: Patients with recurrent major depression were treated with bupropion SR 300 mg/day during an 8-week open-label phase. Responders (based on Clinical Global Impressions Scale for Improvement of Illness scores) entered a randomized, double-blind phase where they received bupropion SR 300 mg/day or placebo for up to 44 weeks. After randomization, relapse was defined as the point at which the investigator intervened by withdrawing the patient from the study to treat depression. RESULTS: Four hundred twenty-three patients were randomized. A statistically significant difference in favor of bupropion SR over placebo was seen in the time to treatment intervention for depression when survival curves were compared (log-rank test, p =.003). Statistically significant separation between bupropion SR and placebo began at double-blind week 12 (p <.05). Adverse events in bupropion SR-treated patients accounted for 9% and 4% of discontinuations from the open-label and double-blind phases, respectively. CONCLUSIONS: Bupropion SR was shown to be effective and well tolerated in decreasing the risk for relapse of depression for up to 44 weeks.

The spectrum of quality-of-life impairments in recurrent geriatric depression.

BACKGROUND: Although recurrent major depression in elderly individuals is a disabling condition, only a few studies have systematically examined the magnitude and specificity of quality-of-life (QOL) impairments in such patients in comparison with matched controls or the elderly population. METHODS: We examined the variations in QOL scores of 100 elderly (age range 60-88 years) patients with moderate to severe recurrent major depression and compared them with published elderly population norms. Disease-specific Quality of Life in Depression Scale (QLDS) and generic Medical Outcomes Short Form-36 Health Survey (SF-36) QOL ratings obtained at baseline were analyzed. RESULTS: Compared with published elderly population norms, depressed subjects showed significant QOL impairments in five of eight baseline SF-36 items (p <.01). Women rated their QOL as worse than men on physical functioning and role physical (p <.01) and showed similar trends on all other QOL items. Compared with younger subjects, subjects aged older than 70 years reported lower QOL on the summary physical component (p <.01) and a trend for higher QOL on the summary mental component (p <.05) of the SF-36. Depression symptom ratings were correlated with some QOL measures, but accounted for less than 10% of the variance. CONCLUSIONS: Despite limitations, such as a cross-sectional design and indirect comparisons with norms generated from another study, our findings confirm the disabling nature of recurrent late-life depression and the importance of targeting both depressive symptoms and broader QOL outcomes in intervention trials.

Improved Health-Related Quality of Life and Reduced Productivity Loss After Treatment With Bupropion Sustained Release: A Study in Patients With Major Depression.

BACKGROUND: This open-label portion of a 2-phase study assessed the effects of the antidepressant bupropion sustained release (SR) on health-related quality of life (QOL) and workplace productivity in patients with major depression. METHOD: Patients (N = 816) with DSM-IV major depression were treated with bupropion SR, 300 mg/day, for 8 weeks. The Clinical Global Impressions scale for Improvement of Illness (CGI-I) was completed at weekly clinic visits. At baseline and week 8, QOL and productivity were assessed. QOL was assessed using the Quality of Life in Depression Scale (QLDS). RESULTS: QOL and productivity were significantly improved from baseline after 8 weeks of treatment with bupropion SR. Mean QLDS scores were 18.98 and 10.36 at baseline and week 8, respectively (mean change = 8.62; p <.001). At week 8 compared with baseline, patients working at a paid job reported missing 1.58 fewer hours of work because of depression during the past 7 days, being 14.6% more effective on the job, working at reduced effectiveness less often, and incurring 6.37 fewer hours of overall lost productivity (p <.001 each variable). Improvements in QOL and productivity were significantly (p <.001) greater in bupropion SR responders (i.e., those with CGI-I scores of "very much improved" or "much improved" during the last 3 weeks of open-label therapy) than in nonresponders. CONCLUSION: Effective treatment of major depression with bupropion SR for 8 weeks is associated with improvements in QOL and reductions in lost workplace productivity. Patients who responded clinically to bupropion SR showed significantly greater improvements in these variables than those who did not respond.