Conectar
The femoral head contralateral to the collapsed femoral head requiring total hip arthroplasty (THA) often manifests in the precollapse stage of osteonecrosis of the femoral head (ONFH). It is not yet demonstrated how autologous concentrated bone marrow injection may prevent collapse of the femoral head concurrent with contralateral THA. The primary objective is to evaluate the efficacy of autologous concentrated bone marrow injection for the contralateral, non-collapsed, femoral head in patients with bilateral ONFH, with the ipsilateral collapsed femoral head undergoing THA.
This is a multicentre, prospective, non-randomised, historical-data controlled study. We will recruit patients with ONFH who are scheduled for THA and possess a non-collapsed contralateral femoral head. Autologous bone marrow will be collected using a point-of-care device. After concentration, the bone marrow will be injected into the non-collapsed femoral head following the completion of THA in the contralateral hip. The primary outcome is the percentage of femoral head collapse evaluated by an independent data monitoring committee using plain X-rays in two directions 2 years after autologous concentrated bone marrow injection. Postinjection safety, adverse events, pain and hip function will also be assessed. The patients will be evaluated preoperatively, and at 6 months, 1 year and 2 years postoperatively.
This protocol has been approved by the Certified Committee for Regenerative Medicine of Tokyo Medical and Dental University and Japan’s Ministry of Healthy, Labour and Welfare and will be performed as a class III regenerative medicine protocol, in accordance with Japan’s Act on the Safety of Regenerative Medicine. The results of this study will be submitted to a peer-review journal for publication. The results of this study are expected to provide evidence to support the inclusion of autologous concentrated bone marrow injections in the non-collapsed femoral head in Japan’s national insurance coverage.
jRCTc032200229.
by Kaori Taniguchi, Takashi Watari, Kiwamu Nagoshi
Classification and analysis of existing data on medical malpractice lawsuits are useful in identifying the root causes of medical errors and considering measures to prevent recurrence. No study has shown the actual prevalence of all closed malpractice claims in Japan, including the number of cases and their trial results. In this study, we illustrated the recent trends of closed malpractice claims by medical specialty, the effects of the acceptance rates and the settlements and clarified the trends and characteristics. This was a descriptive study of all closed malpractice claims data from the Supreme Court in Japan from 2006–2021. Trends and the characteristics in closed malpractice claims by medical specialty and the outcomes of the claims, including settlements and judgments, were extracted. The total number of closed medical malpractice claims was 13,340 in 16 years, with a high percentage ending in settlement (7,062, 52.9%), and when concluding in judgment (4,734, 35.3%), the medical profession (3,589, 75.8%) was favored. When compared by medical specialty, plastic surgery and obstetrics/gynecology were more likely resolved by settlement. By contrast, psychiatry cases exhibited a lower likelihood of settlement, and the percentage of cases resulting in unfavorable outcomes for patients was notably high. Furthermore, there has been a decline in the number of closed medical malpractice claims in Japan in recent years compared to the figures observed in 2006. In particular, the number of closed medical malpractice claims in obstetrics/gynecology and the number of closed medical malpractice claims per 1,000 physicians decreased significantly compared to other specialties. In conclusion, half of the closed malpractice claims were settled, and a low percentage of patients won their cases. Closed medical malpractice claims in Japan have declined in most medical specialties since 2006. Additionally, obstetrics/gynecology revealed a significant decrease since introducing the Obstetrics/Gynecology Medical Compensation System in 2009.
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