IRCCS Istituto Ortopedico Galeazzi, Milan, Italy.
Department of Biomedical Sciences for Health, University of Milan, Milan, Italy.
Eur J Orthop Surg Traumatol. 2023 Oct;33(7):3081-3088. doi: 10.1007/s00590-023-03537-7. Epub 2023 Apr 5.
A clinical trial comparing MB (mobile-bearing) versus FB (fixed-bearing) in medial partial knee arthroplasty (PKA) in octagenarians has been conducted. The focus of the present study was on PROMs, range of motion (ROM), implant positioning and implants survivorship. The hypothesis of the present study was that MB implants performed better than FB in PKA in octogenarians.
The first group received FB PKA-PPK®; the second received MB PKA-Oxford. Patients were not randomly allocated. The following PROMs were administered at T (pre-operatively), T (1 year after surgery), and T (3 years after surgery): visual analogue scale (VAS), Knee Society Score (KSS) and Oxford Knee Score (OKS). Data regarding the implant survivorship and ROM were also collected. Furthermore, the following radiographic parameters were measured: Femoral component varus/valgus; Tibial component varus/valgus; Anteroposterior slope.
At T, 28 patients were included in the FB and 33 in the MB group. The surgical time was shorter in the FB group (p < 0.001). No difference between FB and MB in ROM, VAS, KSS, and OKS at each follow-up (p > 0.05). No difference was found in implant positioning (p > 0.05). At last follow-up, FB group reported three failures caused by aseptic loosening. Four failures were observed in the MB cohort: two for bearing dislocation and two for aseptic loosening. The Kaplan-Meier Curve found no differences in implant survivorship.
According to the main findings of the present clinical trial, MB implants performed similar to FB in PKA in octogenarians. The FB group demonstrated shorted surgical time. No difference was found in patient reported outcome measures, ROM, implant positioning, and survivorship.
Level II, prospective study.
一项比较 MB（活动平台）和 FB（固定平台）在 80 岁以上人群中内侧部分膝关节置换术（PKA）的临床试验已经进行。本研究的重点是 PROMs、活动范围（ROM）、植入物定位和植入物存活率。本研究的假设是 MB 植入物在 80 岁以上人群的 PKA 中比 FB 表现更好。
第一组接受 FB PKA-PPK®；第二组接受 MB PKA-Oxford。患者不是随机分配的。以下 PROMs 在 T（术前）、T（术后 1 年）和 T（术后 3 年）进行测量：视觉模拟量表（VAS）、膝关节协会评分（KSS）和牛津膝关节评分（OKS）。还收集了有关植入物存活率和 ROM 的数据。此外，还测量了以下影像学参数：股骨组件内翻/外翻；胫骨组件内翻/外翻；前后斜率。
在 T 时，FB 组有 28 例患者，MB 组有 33 例患者。FB 组的手术时间更短（p<0.001）。在每个随访中，FB 和 MB 组在 ROM、VAS、KSS 和 OKS 方面均无差异（p>0.05）。植入物定位无差异（p>0.05）。在最后一次随访时，FB 组报告了 3 例因无菌性松动引起的失败。MB 队列观察到 4 例失败：2 例因轴承脱位，2 例因无菌性松动。Kaplan-Meier 曲线发现植入物存活率无差异。
根据本临床试验的主要发现，MB 植入物在 80 岁以上人群的 PKA 中与 FB 表现相似。FB 组手术时间较短。在患者报告的结果测量、ROM、植入物定位和存活率方面无差异。
II 级，前瞻性研究。
