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Autologous concentrated bone marrow injection for precollapse osteonecrosis of the femoral head concurrent with contralateral total hip arthroplasty: protocol for a clinical trial

Por: Homma · Y. · Yamasaki · T. · Tashiro · K. · Okada · Y. · Shirogane · Y. · Watari · T. · Hayashi · K. · Baba · T. · Nagata · K. · Yanagisawa · N. · Ohtsu · H. · Fujiwara · N. · Ando · J. · Yamaji · K. · Tamura · N. · Ishijima · M.
Introduction

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.

Methods and analysis

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.

Ethics and dissemination

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.

Trial registration number

jRCTc032200229.

Relationship between rumination, self-compassion, and psychological health among Japanese university students: A cross-sectional study

by Kaho Yamasaki, Ayaka Sampei, Hiromitsu Miyata

Objectives

Rumination is suggested to exacerbate psychological health, but there is room for investigating the potential protecting factors for individuals with high ruminative tendencies against psychological symptoms. The present cross-sectional study aimed to uncover the associations between rumination as a maladaptive dimension of self-focus, self-compassion, and psychological health, and whether and how components of self-compassion may moderate the associations between rumination and psychological health in Japanese undergraduate students.

Methods

A questionnaire survey was conducted by using both an online platform and a paper-based questionnaire. The survey included established Japanese versions of psychological scales on rumination, self-compassion, perceived stress, trait anxiety, and depression.

Results

The results revealed statistically significant positive correlations between rumination and negative dimensions of self-compassion, and rumination and psychological symptoms. Positive dimensions of self-compassion were significantly negatively correlated with both rumination and psychological symptoms. Reflection as a positive dimension of self-focus did not show significant correlations with most psychological variables. Furthermore, hierarchical multiple regression analyses involving subscales of self-compassion and their interactions with rumination as predictors revealed that the interactions between rumination and components of self-compassion, i.e., over-identification and mindfulness, significantly predicted trait anxiety. Higher rumination predicted higher anxiety when over-identification was high, but not when over-identification was low. Also, lower rumination predicted lower anxiety when mindfulness was high, but not when mindfulness was low.

Conclusions

The results suggest significant associations between rumination, components of self-compassion, and psychological health in a population of Japanese undergraduate students. The data also suggest that components of self-compassion play moderating roles in the relationship between rumination and psychological health, potentially serving as aggravating/protective factors for psychological health. Longitudinal studies and comparisons between different cultures should be conducted in the future quest.

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