Gousopoulos Lampros, Dobbelaere Andreas, Ratano Salvatore, Bondoux Louka, Tibesku Carsten O, Aït-Si-Selmi Tarik, Bonnin Michel P
Ramsay Santé, Hôpital Privé Jean Mermoz, Centre Orthopédique Santy, Lyon, France.
KniePraxis, Straubing, Germany.
Knee Surg Sports Traumatol Arthrosc. 2023 Apr;31(4):1276-1283. doi: 10.1007/s00167-023-07318-x. Epub 2023 Jan 19.
The purpose was to report detailed patient-reported outcome measures (PROMs) and satisfaction rates for computed tomography (CT)-based custom TKA at minimum follow-up of 2 years. The hypothesis was that custom TKA combined with 'personalised alignment' would yield equivalent or better PROMs compared to values reported in systematic reviews and meta-analyses on off-the-shelf (OTS) TKA.
Of an initial cohort of 150 custom TKAs, four died (unrelated to surgery), one required a revision, and five refused participation, leaving 140 patients for analysis. Patients completed pre- and post-operative PROMs (Oxford Knee Score (OKS), Forgotten Joint Score (FJS), Knee injury and Osteoarthritis Outcome Score (KOOS), Western Ontario and McMaster osteoarthritis index (WOMAC)) as well as overall level of satisfaction. Proportions that attained a patient acceptable symptom state (PASS) were calculated for OKS and FJS. Clinical findings were compared to the average scores reported for PROMs in recent systematic reviews and/or meta-analyses on OTS TKA. Descriptive statistics were used to summarise the clinical findings as means, standard deviations (SD) and ranges, or numbers and percentages.
At mean follow-up 33.5 ± 4.5 months, 94% (135/143) were either satisfied or very satisfied. Proportions that achieved PASS were 89% for OKS (120/135), and 85% for FJS (118/139). Median OKS, WOMAC and KOOS Symptoms and Pain scores were all within the 4th quartile of medians reported in systematic reviews and/or meta-analyses.
At a minimum follow-up of two years following custom TKA combined with 'personalised alignment', 94% of patients were either satisfied or very satisfied, and the PASS criteria were achieved in 89% for OKS and 85% for FJS, all of which compare favourably to published outcomes of OTS TKA. Direct comparisons to the literature may not be appropriate, however, considering the heterogeneity of patient demographics and alignment techniques. Randomised controlled trials with sufficient statistical power are needed to corroborate these findings and generalise them to unselected TKA patients.
IV, retrospective cohort study.
本研究旨在报告基于计算机断层扫描(CT)的定制全膝关节置换术(TKA)在至少2年随访期内详细的患者报告结局指标(PROMs)和满意度。研究假设为,与系统评价和荟萃分析中报道的现成(OTS)TKA的值相比,定制TKA结合“个性化对线”将产生相当或更好的PROMs。
在最初的150例定制TKA队列中,4例死亡(与手术无关),1例需要翻修,5例拒绝参与,最终140例患者纳入分析。患者完成术前和术后的PROMs(牛津膝关节评分(OKS)、遗忘关节评分(FJS)、膝关节损伤和骨关节炎结局评分(KOOS)、西安大略和麦克马斯特大学骨关节炎指数(WOMAC))以及总体满意度。计算OKS和FJS达到患者可接受症状状态(PASS)的比例。将临床结果与近期关于OTS TKA的系统评价和/或荟萃分析中报道的PROMs平均评分进行比较。采用描述性统计方法将临床结果总结为均值、标准差(SD)和范围,或例数和百分比。
平均随访33.5±4.5个月时,94%(135/143)的患者表示满意或非常满意。OKS达到PASS的比例为89%(120/135),FJS为85%(118/139)。OKS、WOMAC以及KOOS症状和疼痛评分的中位数均处于系统评价和/或荟萃分析中报道的中位数的第4四分位数范围内。
在定制TKA结合“个性化对线”术后至少2年的随访中,94%的患者表示满意或非常满意,OKS达到PASS标准的比例为89%,FJS为85%,所有这些结果均优于已发表的OTS TKA结局。然而,考虑到患者人口统计学和对线技术的异质性,与文献的直接比较可能并不合适。需要进行具有足够统计学效力的随机对照试验来证实这些发现,并将其推广到未选择的TKA患者。
IV,回顾性队列研究。