Department of Medicine for Orthopaedics and Motor Organ, Juntendo University Graduate School of Medicine, Tokyo, Japan
Department of Orthopaedic Surgery, Juntendo University School of Medicine, Tokyo, Japan.
BMJ Open. 2024 May 8;14(5):e082243. doi: 10.1136/bmjopen-2023-082243.
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.
需要全髋关节置换术 (THA) 的塌陷股骨头对侧的股骨头通常在股骨头坏死 (ONFH) 的塌陷前阶段表现出来。目前还没有证明自体浓缩骨髓注射如何预防同侧 THA 同时发生股骨头塌陷。主要目的是评估自体浓缩骨髓注射治疗双侧 ONFH 患者对侧未塌陷股骨头的疗效，同侧塌陷股骨头行 THA。
这是一项多中心、前瞻性、非随机、历史数据对照研究。我们将招募计划接受 THA 且具有未塌陷对侧股骨头的 ONFH 患者。使用即时护理设备采集自体骨髓。在对侧髋关节 THA 完成后，将浓缩后的骨髓注入未塌陷的股骨头。主要结局是通过独立数据监测委员会使用二维平片评估自体浓缩骨髓注射后 2 年时股骨头塌陷的百分比。还将评估注射后的安全性、不良事件、疼痛和髋关节功能。患者将在术前、术后 6 个月、1 年和 2 年进行评估。
本方案已获得东京医科齿科大学和日本厚生劳动省再生医学认证委员会的批准，并将作为日本再生医学法规定的 III 类再生医学方案进行。该研究的结果将提交给同行评议期刊发表。本研究的结果有望为支持将自体浓缩骨髓注射纳入日本国民保险覆盖的未塌陷股骨头提供证据。
jRCTc032200229。
