Homma Yasuhiro, Uchino Sayuri, Nagao Masashi, Wakayama Takanori, Fukusato Shin, Baba Tomonori, Watari Taiji, Hayashi Koju, Saita Yoshitomo, Ishijima Muneaki
Department of Medicine for Orthopaedics and Motor Organ, Juntendo University Graduate School of Medicine, Bunkyo-ku, Tokyo, Japan.
Department of Orthopaedic, Faculty of Medicine, Juntendo University, Bunkyo-ku, Tokyo, Japan.
Regen Ther. 2023 Nov 29;25:61-67. doi: 10.1016/j.reth.2023.11.012. eCollection 2024 Mar.
Although numerous studies have reported outcomes with various conservative approaches for the iliopsoas impingement after total hip arthroplasty (THA), reports on the use of locoregional autologous platelet rich plasma (PRP) injections for the iliopsoas impingement after THA are lacking. This phase 1 study therefore aimed to investigate the safety and feasibility of locoregional PRP injection for iliopsoas impingement after THA.
Patients diagnosed with iliopsoas impingement after THA who met the criteria for participation (symptoms persisting for more than 3 months, aged 20 years or older, and unable to receive non-steroidal analgesic or anti-inflammatory drugs) were eligible to participate in this clinical study. The primary endpoint was observed adverse events including procedure-related pain, and the secondary endpoints included pain and functionality of the hip joint, that were assessed using the Western Ontario and McMaster Universities Arthritis Index, Japanese Hip Disease Evaluation Questionnaire, and Forgotten Joint Score-12.
Three patients were screened for eligibility, and 3 patients were finally included in this study. Two participants (patients 1 and 2; aged 66 and 65 years, respectively) were female. The third participant (patient 3; age 73 years) was male. All patients experienced adverse events; however, none were found to be serious. None of the patients experienced any infections, or intra- or post-operative symptoms of nerve damage, or subcutaneous haemorrhage owing to the administration of locoregional PRP. Although patient 2 showed almost complete resolution of the symptom, patient 1 and 3 demonstrated persistent groin pain after the injection.
We demonstrated the results of preliminary phase 1 prospective observational clinical study that administration of locoregional PRP injections for iliopsoas impingement following THA is both, safe and feasible.
尽管众多研究报告了全髋关节置换术（THA）后髂腰肌撞击症采用各种保守方法的治疗结果，但关于局部自体富血小板血浆（PRP）注射治疗THA后髂腰肌撞击症的报道却很缺乏。因此，这项1期研究旨在探讨局部PRP注射治疗THA后髂腰肌撞击症的安全性和可行性。
诊断为THA后髂腰肌撞击症且符合参与标准（症状持续超过3个月、年龄20岁或以上、无法接受非甾体类镇痛药或抗炎药）的患者有资格参与本临床研究。主要终点是观察到的不良事件，包括与手术相关的疼痛，次要终点包括髋关节的疼痛和功能，使用西安大略和麦克马斯特大学骨关节炎指数、日本髋关节疾病评估问卷和遗忘关节评分-12进行评估。
筛选了3名患者以确定其是否符合资格，最终3名患者纳入本研究。两名参与者（患者1和患者2；分别为66岁和65岁）为女性。第三名参与者（患者3；73岁）为男性。所有患者均经历了不良事件；然而，未发现严重不良事件。由于局部注射PRP，没有患者发生任何感染、神经损伤的术中或术后症状或皮下出血。尽管患者2的症状几乎完全缓解，但患者1和患者3在注射后仍有持续的腹股沟疼痛。
我们展示了1期初步前瞻性观察性临床研究的结果，即THA后局部注射PRP治疗髂腰肌撞击症是安全可行的。
