Fractures in Charcot neuro-osteoarthropathy (CN) often fail to heal despite prolonged immobilization with below-knee casting. The aim of the study was to assess the efficacy of recombinant human parathyroid hormone (PTH) in reducing time to resolution of CN and healing of fractures. RESEARCH DESIGN AND METHODSPeople with diabetes and acute (active) Charcot foot were randomized (doubleblind) to either full-length PTH (1-84) or placebo therapy, both in addition to below-knee casting and calcium and vitamin D3 supplementation. The primary outcome was resolution of CN, defined as a skin foot temperature difference >2 C at two consecutive monthly visits. RESULTSMedian time to resolution was 5 months (95% CI 4, 12) in intervention and 6 months (95% CI 2, 9) in control. There was no significant difference in time to resolution between the groups (mixed-effects logistic regression; P 5 0.64). The hazard ratio of resolution was 0.84 (95% CI 0.41, 1.74; P 5 0.64), and the odds ratio of resolution by 12 months was 1.22 (0.90, 1.67; P 5 0.20) (intervention vs. control). On linear regression analysis, there were no significant differences in the effect of treatment on fracture scores quantitated on MRI scans (coefficient 0.13 [95% CI À0.62, 0.88]; P 5 0.73) and on foot and ankle X-rays (coefficient 0.30 [95% CI À0.03, 0.63]; P 5 0.07). CONCLUSIONSThis double-blind placebo-controlled trial did not reduce time to resolution or enhance fracture healing of CN. There was no added benefit of daily intervention with PTH (1-84) to below-knee casting in achieving earlier resolution of CN.Charcot neuro-osteoarthropathy (CN), or Charcot foot, is one of the most disabling complications of diabetic neuropathy (1,2). Simple trauma sets off uncontrolled inflammation and pathological fractures, resulting in severe foot deformity with an
In this article, we describe emergency and elective pathways within our orthopedic multidisciplinary inpatient care of patients with diabetic foot problems. We performed a retrospective cohort review of 19 complex patients requiring orthopedic surgical treatment of infected ulceration or Charcot feet or deformity at our institution. A total of 30 admissions (19 emergency, 11 elective) were included. The pathways were coordinated by a multidisciplinary team and comprised initial assessment and investigation and a series of key events, which consisted of emergency and elective surgery together with the introduction, and change of intravenous antibiotics when indicated. Patients had rigorous microbiological assessment, in the form of deep ulcer swabs, operative tissue specimens, joint aspirates, and blood cultures according to their clinical presentation as well as close clinical and biochemical surveillance, which expedited the prompt institution of key events. Outcomes were assessed using amputation rates and patient satisfaction. In the emergency group, there were 5.6 ± 3.0 (mean ± SD) key events per admission, including 4.2 ± 2.1 antibiotic changes. In the elective group, there were 4.8 ± 1.4 key events per inpatient episode, with 3.7 ± 1.3 antibiotic changes. Overall, there were 3 minor amputations, and no major amputations. The podiatric and surgical tissue specimens showed a wide array of Gram-positive, Gram-negative, aerobic and anaerobic isolates and 15% of blood cultures showed bacteremia. When 9 podiatric specimens were compared with 9 contemporaneous surgical samples, there was concordance in 2 out of 9 pairs. We have described the successful modern care of the orthopedic diabetic foot patient, which involves close clinical, microbiological, and biochemical surveillance by the multidisciplinary team directing patients through emergency and elective pathways. This has enabled successful surgical intervention involving debridement, pressure relief, and stabilization, with low rates of amputation.
PURPOSE Clinical trials of novel and targeted agents increasingly require biomarkers for eligibility. Precision oncology continues to evolve, but challenges hamper broad use of molecular profiling (MP) that could increase the number of patients benefiting from targeted therapy. We implemented an integrated clinical genomics program (CGP), including a virtual Molecular Tumor Board (MTB), and examined its impact on MP use and impact on clinical trial accrual in a multisite regional-based cancer system with an emphasis on effects for isolated clinicians. METHODS We assessed MP and MTB use from 2010 to 2020 by practice location, physician experience, and patient characteristics. Use of MTB-recommended treatments was assessed. Clinical trial enrollment was evaluated for patients with MP versus MP and MTB review. RESULTS After CGP implementation, the number of physicians using MP and the number of MP tests increased ≥ 10-fold. The proportion of Hispanic patients with MP was the same as that in the system (both 2%) with marginal differences observed in the proportion of African Americans tested compared with the system population (16% v 19%). Physicians followed MTB treatment recommendations in 74% of cases. Rapid clinical decline was the most common reason why physicians did not follow MTB recommendations. Clinical trial accrual was 15% (669 of 4,459) for patients with MP alone and 28% (94 of 334) with both MP and MTB review. Clinical trial availability and patient out-of-pocket costs affected MP use. CONCLUSION Integrating CGP into clinical workflow with decision support tools, trial matching, and management of patient costs led to increased use of MP by physicians with all levels of experience, enhanced clinical trial accrual, and has the potential to reduce disparities in MP.
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