Liu Jonathan, Daher Mohammad, Laperche Jacob, Clippert Drew, Ibrahim Zainab, Barrett Thomas J, Antoci Valentin
Arch Bone Jt Surg. 2025;13(2):100-105. doi: 10.22038/ABJS.2024.80407.3674.
The purpose of this study is to compare the Depuy curved (CVD) polyethylene insert to the curved plus (CVD+) design in TKA, which has an increased dished curve for increased articulation congruence and thus secondary anterior to posterior stability.
A randomized controlled trial with 100 patients was conducted to compare two knee replacement designs (CVD and CVD+ polyethylene inserts) using the Johnson and Johnson DePuy PFC Sigma total knee replacement. All participants, were randomized and blinded to reduce bias. The trial achieved 100% recruitment and maintained blinding throughout the study. Demographics, baseline characteristics, and KOOS scores were recorded pre-operatively, and at 3 and 12 months postoperatively. In addition, physical and mental component scores (PCS and MCS) were collected at 12 months post-operatively.
Sixty patients had preoperative data, split equally into CVD and CVD+ groups. The cohort's average age was 71.47 years, and 72% were female, with no statistically significant demographic differences between groups. Preoperative measures showed no differences in Pain, ADL, or QOL. At 3 months, no significant differences were noted, though the QOL difference was 64.45 ± 16.57 for CVD and 52.94 ± 27.1 for CVD+ (p = 0.15). At 12 months, trends favored the CVD group, but differences in Pain, ADL, QOL, PCS, and MCS were not significant. Complications were similar, except for stiffness, with 0 cases in the CVD group and 3 in the CVD+ group at 3 months; both had 2 additional cases at 12 months.
In our study, there was no difference between designs in terms of pain, activities of daily living, and standard outcomes. Further studies are required to support the benefit of increased congruence in the CVD+ design, even though widespread adoption has been common across the industry.
本研究旨在比较Depuy曲面（CVD）聚乙烯内衬与全膝关节置换术（TKA）中的曲面增强型（CVD+）设计，后者具有增加的碟形曲线以提高关节吻合度，从而增强前后稳定性。
进行了一项随机对照试验，纳入100例患者，使用强生DePuy PFC Sigma全膝关节置换术比较两种膝关节置换设计（CVD和CVD+聚乙烯内衬）。所有参与者均被随机分组并设盲以减少偏倚。该试验实现了100%的招募率，并在整个研究过程中保持设盲。术前、术后3个月和12个月记录人口统计学数据、基线特征和膝关节损伤与骨关节炎疗效评分系统（KOOS）分数。此外，术后12个月收集生理和心理成分评分（PCS和MCS）。
60例患者有术前数据，平均分为CVD组和CVD+组。队列的平均年龄为71.47岁，72%为女性，两组间人口统计学差异无统计学意义。术前测量显示疼痛、日常生活活动能力（ADL）或生活质量（QOL）无差异。在3个月时，未观察到显著差异，尽管CVD组的QOL差异为64.4±16.57，CVD+组为52.94±27.1（p=0.15）。在12个月时，趋势有利于CVD组，但疼痛、ADL、QOL、PCS和MCS的差异无统计学意义。并发症相似，但僵硬情况除外，CVD组在3个月时为0例，CVD+组为3例；两组在12个月时均有另外2例。
在我们研究中，两种设计在疼痛、日常生活活动能力和标准结局方面无差异。尽管该行业已普遍广泛采用CVD+设计，但仍需要进一步研究来支持其增加吻合度的益处。
