| 齐大虎,张伟凯,杨勇,等.新型国产髋关节假体用于人工髋关节置换的随机对照研究.骨科,2022,13(1): 28-33. |
| 新型国产髋关节假体用于人工髋关节置换的随机对照研究 |
| A Randomized Controlled Clinical Trial of the New Domestic Hip Joint Prostheses for Total Hip Arthroplasty |
| 投稿时间：2021-11-19 |
| DOI：10.3969/j.issn.1674-8573.2022.01.008 |
| 中文关键词: 关节成形术，置换，髋 随机对照试验 髋关节假体 |
| 英文关键词: Arthroplasty, replacement, hip Randomized controlled trial Hip joint prosthesis |
| 基金项目:湖北省自然科学基金重点项目（2020CFA019） |
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| 中文摘要: |
| 目的 通过随机对照临床试验，评价一种新型国产髋关节假体用于人工全髋关节置换术（total hip arthroplasty，THA）的临床疗效和安全性。方法 本研究采用多中心、随机、单盲、阳性平行对照设计，在全国5家医院共招募72例受试者，分别纳入试验组和对照组，各36例。试验组使用新型国产髋关节假体，对照组使用成熟的髋关节假体。所有受试者在术前及术后3个月、6个月、1年、2年进行随访评估，评价记录髋关节Harris评分和不良事件的发生情况，评估产品的临床应用价值。结果 共有3例受试者退出研究，其中试验组1例，对照组2例。试验组和对照组的髋关节Harris评分均较术前明显提高（P＜0.05），但各随访时间点的数据进行组间比较，差异无统计学意义（P＞0.05）。两组间的不良事件发生率比较，差异无统计学意义（P＞0.05）。结论 新型国产髋关节假体用于THA，可显著改善病人髋关节功能，其临床疗效和安全性与成熟假体相近。 |
| 英文摘要: |
| Objective To evaluate the clinical efficacy and safety of a new domestic hip joint prostheses for total hip arthroplasty (THA) by a randomized controlled clinical trial. Methods A multi-center, randomized, single-blind, positive parallel control design was used in this study. Totally, 72 subjects were recruited in 5 hospitals across the country, and allocated into experimental group and control group evenly. The new domestic hip joint prostheses were used in the experimental group, while the proven hip joint prostheses were used in the control group. Follow-up evaluations were carried out before the operation, and 3 months, 6 months, 1 year, 2 years after the operation. The Harris score and the incidence of adverse events were evaluated and recorded to confirm the clinical application value of the new hip prostheses. Results A total of 3 cases withdrew from this study, including 1 in the experimental group and 2 in the control group. The Harris scores of the experimental group and the control group after the operation were significantly higher than those before the operation (P＜0.05), but there was no statistically significant difference between the two groups at each follow-up time point (P＞0.05). There was no statistically significant difference in the incidence of adverse events between the two groups (P＞0.05). Conclusion The new domestic hip prostheses can significantly improve the hip joint function of the patients, and there was no significant difference in clinical efficacy and safety between the two hip joint prostheses. |
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