Xue Yi, Lu Tong, Xu Yue, Cao Xi
Department of Orthopedics, Changshu Hospital Affiliated to Nanjing University of Chinese Medicine, Jiangsu, China.
Medicine (Baltimore). 2020 Dec 4;99(49):e23232. doi: 10.1097/MD.0000000000023232.
Platelet-rich plasma (PRP), an autologous platelet concentrate (contain a large number of growth factors), has been widely investigated in healing and rebuilding the bone and tendon tissue. The objective of this prospective randomized research is to study and then compare the long-term effectiveness of the repair of arthroscopic rotator cuff without and with the platelet-rich plasma. It is assumed that there is no difference in the clinical results between patients receiving the repair of arthroscopic rotator cuff and the patients who do not receive PRP enhancement.
This current study is a prospective, single-center, controlled, and randomized experiment. This study was reviewed and permitted via the institutional review committee of our hospital. All the patients will receive the written informed consent in order to involve in our clinical experiment. Patients were selected from the patients who received the repair of arthroscopic rotator cuff. Patients who meet the following conditions will be included in this study: ages ranges from 18 to 55; patients with complete tear of rotator cuff confirmed during operation; the patients agreed to wear the abduction stent for 4 weeks after operation; the preoperative count of platelet count is >150,000. All patients were evaluated at follow-up and baseline for the scores of Constant-Murley (CM) and American Shoulder and Elbow Surgeons (ASES), the numerical rating scale (NRS), and retear rate. The analysis is implemented with the SPSS 16.0 (SPSS Inc., Chicago, IL), the significance level remain at P < .05.
The results of this study will provide useful new information on whether PRP is effective in the arthroscopic rotator cuff repair patients.
This study protocol was registered in Research Registry (researchregistry6108).
富含血小板血浆(PRP),一种自体血小板浓缩物(含有大量生长因子),已在骨和肌腱组织的愈合与重建方面得到广泛研究。这项前瞻性随机研究的目的是研究并比较关节镜下肩袖修复术在不使用和使用富含血小板血浆情况下的长期疗效。假设接受关节镜下肩袖修复术的患者与未接受PRP增强的患者在临床结果上没有差异。
本研究是一项前瞻性、单中心、对照、随机实验。本研究经我院机构审查委员会审核并批准。所有患者均需签署书面知情同意书以参与我们的临床试验。患者选自接受关节镜下肩袖修复术的患者。符合以下条件的患者将被纳入本研究:年龄在18至55岁之间;术中证实肩袖完全撕裂的患者;患者同意术后佩戴外展支架4周;术前血小板计数>150,000。所有患者在随访和基线时均接受Constant-Murley(CM)评分、美国肩肘外科医师学会(ASES)评分、数字评定量表(NRS)以及再撕裂率评估。使用SPSS 16.0(SPSS公司,伊利诺伊州芝加哥)进行分析,显著性水平保持在P<0.05。
本研究结果将为PRP在关节镜下肩袖修复患者中是否有效提供有用的新信息。
本研究方案已在Research Registry(researchregistry6108)注册。