Johnson Eli, Cottrill Ethan, Mann Tara, Willey James, Kelly Cambre, Dunaway Daniel
Department of Neurosurgery, Duke University School of Medicine, Durham, USA.
Department of Orthopedics, Duke University Medical Center, Durham, USA.
Cureus. 2025 Mar 8;17(3):e80270. doi: 10.7759/cureus.80270. eCollection 2025 Mar.
Total knee arthroplasty (TKA) is a common surgical intervention for severe knee arthritis resulting in joint or cartilage destruction, with success largely depending on prosthetic design and surgical technique. This study compares two Cruciate Retaining (CR) TKA systems, the iTotal® Identity CR system (ConforMIS; Wilmington, MA), a patient-specific knee (PSK) system, with the Triathlon® Total Knee System (Stryker; Kalamazoo, MI), a standard off-the-shelf (OTS) system, hypothesizing that the PSK system results in better clinical outcomes and reduced costs.
This single-center, prospective study included 188 patients (217 knees) who underwent TKA with either the PSK or OTS system from August 2017 to February 2021. Participants were enrolled if they had a clinical indication for total knee replacement and were deemed suitable candidates for either system. All participants were adults (18+ years) and capable of providing informed consent. Data on operative times, complications, patient-reported outcomes, and cost metrics were collected and analyzed.
Compared to the OTS group, the PSK group had a significantly shorter average total operating room (OR) time (85.2 vs. 95.9 minutes, p < 0.001), tourniquet time (50.2 vs. 64.3 minutes, p < 0.001), OR instrument setup time (5.0 vs. 11.9 minutes, p < 0.001) and OR instrument tear down time (1.5 vs. 7.0 minutes, p < 0.001). At preoperative baseline, the PSK participants had a worse mean Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS-JR) score (40.73 vs. 49.6, p <0.001) and worse Knee Society Scores (KSS) (50.9 vs. 62.7, p <0.001) compared to the OTS group. Finally, the PSK group demonstrated greater mean improvement postoperatively in both the KOOS-JR (37.33 vs. 24.61, p <0.001) and the KSS (113.1 vs. 98.1, p <0.001) scores, compared to the OTS group.
The PSK system demonstrated advantages in operative efficiency and improved patient-reported outcomes at the three-month follow-up compared to a standard OTS knee replacement system. These findings highlight potential benefits in adopting patient-specific implants in TKA, with implications for both clinical outcomes and healthcare cost savings. However, further research with longer follow-up periods in diverse patient populations is necessary to fully understand the long-term implications of patient-specific knee replacement systems.
全膝关节置换术（TKA）是针对导致关节或软骨破坏的严重膝关节炎的常见外科手术干预，其成功很大程度上取决于假体设计和手术技术。本研究比较了两种保留交叉韧带（CR）的TKA系统，即iTotal® Identity CR系统（ConforMIS公司；马萨诸塞州威尔明顿），一种定制膝关节（PSK）系统，与Triathlon®全膝关节系统（史赛克公司；密歇根州卡拉马祖），一种标准的现货供应（OTS）系统，假设PSK系统能带来更好的临床结果并降低成本。
这项单中心前瞻性研究纳入了188例患者（217个膝关节），这些患者在2017年8月至2021年2月期间接受了使用PSK或OTS系统的TKA手术。如果患者有全膝关节置换的临床指征且被认为适合这两种系统中的任何一种，则纳入研究。所有参与者均为成年人（18岁及以上）且能够提供知情同意书。收集并分析了手术时间、并发症、患者报告的结果和成本指标等数据。
与OTS组相比，PSK组的平均总手术室（OR）时间显著更短（85.2分钟对95.9分钟，p<0.001），止血带使用时间（50.2分钟对64.3分钟，p<0.001），OR器械设置时间（5.0分钟对11.9分钟，p<0.001）以及OR器械拆卸时间（1.5分钟对7.0分钟，p<0.001）。在术前基线时，与OTS组相比，PSK参与者的平均膝关节损伤和骨关节炎关节置换结局评分（KOOS-JR）更差（40.73对49.6，p<0.001），膝关节协会评分（KSS）也更差（50.9对62.7，p<0.001）。最后，与OTS组相比，PSK组术后在KOOS-JR（37.33对24.61，p<0.001）和KSS（113.1对98.1，p<0.001）评分上的平均改善更大。
与标准的OTS膝关节置换系统相比，PSK系统在三个月随访时显示出手术效率优势以及改善患者报告的结果。这些发现突出了在TKA中采用定制植入物的潜在益处，对临床结果和医疗成本节约都有影响。然而，需要在不同患者群体中进行更长随访期的进一步研究，以充分了解定制膝关节置换系统的长期影响。
