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单半径与多半径股骨在全膝关节置换术中的比较:前瞻性随机对照试验的荟萃分析。

Comparison of Single-Radius with Multiple-Radius Femur in Total Knee Arthroplasty: A Meta-Analysis of Prospective Randomized Controlled Trials.

机构信息

Department of Orthopeadic Surgery, Xiangya Hospital Central South University, Changsha, China.

Sinai Health System, University of Toronto, Toronto, Canada.

出版信息

Orthop Surg. 2022 Sep;14(9):2085-2095. doi: 10.1111/os.13391. Epub 2022 Aug 4.

Abstract

BACKGROUND

Whether there was clinical superiority for the single-radius prosthesis over the multi-radius prothesis in total knee arthroplasty (TKA) still remains to be clarified. We updated a meta-analysis including prospective randomized controlled trials (RCTs) to compare the clinical prognosis of patients receiving single-radius TKA (SR-TKA) or multi-radius TKA (MR-TKA).

METHODS

We searched the databases of PubMed, Web of Science, EMBASE, Cochrane Library, MEDLINE for eligible RCTs. Two reviewers evaluated the study quality according to the Risk of Bias tool of the Cochrane Library and extracted the data in studies individually. The extracted data included the baseline data and clinical outcome. The baseline data include the author's name, country, and year of included studies, the name of knee prosthesis used in studies, sample size, follow-up time, and BMI of patients. The clinical data comprised primary indicators including postoperative knee range of motion (ROM), sit-to-stand rest, severe postoperative scorings, such as visual analog scale (VAS), American Knee Society knee score (AKS), Oxford knee scoring (OKS), and SF-36 Quality of Life Scale, as well as various secondary indicators of complications including anterior knee pain, postoperative infection, aseptic prosthesis loosening, and prosthesis revision. The data analysis was performed using Review Manager 5.3 software and STATA 12.0. The sensitivity analysis was performed using STATA 12.0.

RESULTS

A total of 13 RCTs, along with 1720 patients and 1726 knees, were finally included in our present meta-analysis. We found that patients in SR-TKA group performed better in the sit-to-stand test (OR = 1.89, 95% CI: 1.05-3.41, p = 0.03) and satisfaction evaluation (OR = 3.27, 95% CI: 1.42-7.53, p = 0.005), which were only evaluated in two included RCTs. While no significant difference was found between SR-TKA and MR-TKA groups in terms of postoperative ROM, VAS scoring, AKS scoring, SF-36 scoring, OKS scoring, and various complications including anterior knee pain, postoperative infection, aseptic prosthesis loosening, and prosthesis revision.

CONCLUSION

In conclusion, our present meta-analysis indicated that SR implants were noninferior to MR implants in TKA, and SR implants could be an alternative choice over MR implants, since patients after SR-TKA felt more satisfied and performed better in the sit-to-stand test, with no significant difference in complications between SR-TKA and MR-TKA groups. While more relevant clinical trials with long-term follow-up time and specific tests evaluating the function of knee extension mechanism should be carried out to further investigate the clinical performance of SR implants.

摘要

背景

单半径假体与多半径假体在全膝关节置换术(TKA)中是否具有临床优势仍有待阐明。我们更新了一项荟萃分析,纳入了前瞻性随机对照试验(RCT),以比较接受单半径 TKA(SR-TKA)或多半径 TKA(MR-TKA)的患者的临床预后。

方法

我们检索了 PubMed、Web of Science、EMBASE、Cochrane Library、MEDLINE 数据库,以获取符合条件的 RCT。两位评审员根据 Cochrane 图书馆的偏倚风险工具评估研究质量,并单独提取研究中的数据。提取的数据包括基线数据和临床结果。基线数据包括作者姓名、国家和纳入研究年份、研究中使用的膝关节假体名称、样本量、随访时间和患者 BMI。临床数据包括术后膝关节活动度(ROM)、坐站休息、术后严重评分(如视觉模拟评分(VAS)、美国膝关节协会评分(AKS)、牛津膝关节评分(OKS)和 SF-36 生活质量量表)以及各种并发症的次要指标,包括前膝疼痛、术后感染、无菌假体松动和假体翻修。数据分析使用 Review Manager 5.3 软件和 STATA 12.0 进行。使用 STATA 12.0 进行敏感性分析。

结果

共有 13 项 RCT,共 1720 名患者和 1726 个膝关节,最终纳入本荟萃分析。我们发现,SR-TKA 组患者在坐站测试(OR=1.89,95%CI:1.05-3.41,p=0.03)和满意度评估(OR=3.27,95%CI:1.42-7.53,p=0.005)方面表现更好,这仅在两项纳入的 RCT 中进行了评估。而在术后 ROM、VAS 评分、AKS 评分、SF-36 评分、OKS 评分以及包括前膝疼痛、术后感染、无菌假体松动和假体翻修在内的各种并发症方面,SR-TKA 组与 MR-TKA 组之间无显著差异。

结论

综上所述,本荟萃分析表明,SR 植入物在 TKA 中与 MR 植入物非劣效,并且 SR 植入物可能是 MR 植入物的替代选择,因为 SR-TKA 后的患者感觉更满意,坐站测试表现更好,SR-TKA 组与 MR-TKA 组在并发症方面无显著差异。然而,应该进行更多具有长期随访时间和特定测试的相关临床试验,以进一步研究 SR 植入物的临床性能,以评估膝关节伸展机制的功能。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/84e5/9483041/7109cc9583fa/OS-14-2085-g003.jpg

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