Department of Orthopedic Surgery, West China Hospital, West China Medical School, Sichuan University, Chengdu, People's Republic of China.
West China School of Nursing, Sichuan University/Department of Orthopedics, West China Hospital, Sichuan University, Chengdu, People's Republic of China.
Orthop Surg. 2024 Nov;16(11):2671-2679. doi: 10.1111/os.14178. Epub 2024 Aug 22.
Previous cementless total knee arthroplasty (TKA) designs faced challenges with insufficient initial fixation on tibial side, resulting in inferior functional outcomes and survival rates. The Zoned Trabecular Bone Cementless Knee is a novel implant designed for cementless TKA which aims to achieve excellent initial fixation, promoting effective osseointegration. The aim of this research was to compare the early clinical and radiographic results of this cementless TKA with cemented TKA.
Between September 2021 and April 2022, 64 patients (64 knees) were recruited in this prospective randomized controlled trial to receive either cementless 3D-printed trabecular metal TKA or a cemented posterior stabilized TKA. Preoperative and postoperative clinical evaluations, including the range of motion (ROM), Knee Society Score (KSS), and the Reduced Western Ontario and MacMaster Universities Score (WOMAC), were conducted and analyzed for comparison. Radiographs and computed tomography scans were utilized to assess the initial fixation. The complications between the two groups were also recorded and compared. Continuous data were analyzed for significance using independent-samples t-test or the Mann-Whitney U test and categorical data were analyzed using chi-squared or Fisher's exact test.
Both groups demonstrated significant enhancement at 12 months follow-up in the ROM compared with baseline (ROM: 94.7 ± 23.4 vs. 113.1 ± 12.3 in cementless group and 96.5 ± 14.7 vs. 111.0 ± 12.8 in cemented group, p < 0.05). However, no statistical differences were observed between the two groups in postoperative ROM, KSS, or WOMAC score. The radiographs and computed tomography scans showed similar results, including radiolucent lines and osteolysis in either femoral or tibial. Additionally, there was no statistical difference in the overall complication rate between the two groups. Notably, one patient in the cementless TKA group required revision for periprosthetic infection as the end point.
This novel 3D-printed trabecular metal cementless TKA achieved comparable clinical outcomes and initial fixation to cemented TKA in early stage. Longer-term examination is necessary to validate these results.
既往非骨水泥全膝关节置换术（TKA）设计存在胫骨侧初始固定不足的问题，导致功能结果和生存率欠佳。Zoned Trabecular Bone Cementless Knee 是一种新型植入物，专为非骨水泥 TKA 设计，旨在实现优异的初始固定，促进有效的骨整合。本研究旨在比较这种非骨水泥 TKA 与骨水泥 TKA 的早期临床和影像学结果。
2021 年 9 月至 2022 年 4 月，前瞻性随机对照试验纳入 64 例（64 膝）患者，分别接受 3D 打印多孔金属非骨水泥 TKA 或骨水泥后稳定型 TKA。进行术前和术后临床评估，包括关节活动度（ROM）、膝关节协会评分（KSS）和简化西部安大略省和麦克马斯特大学评分（WOMAC），并进行比较。使用 X 线和计算机断层扫描（CT）评估初始固定情况。记录两组的并发症并进行比较。采用独立样本 t 检验或曼-惠特尼 U 检验对连续数据进行分析，采用卡方检验或 Fisher 确切概率法对分类数据进行分析。
两组患者在 12 个月随访时 ROM 均较基线显著改善（非骨水泥组：ROM：94.7±23.4 比 113.1±12.3；骨水泥组：ROM：96.5±14.7 比 111.0±12.8，p<0.05）。但两组术后 ROM、KSS 和 WOMAC 评分无统计学差异。X 线和 CT 显示，两组在股骨或胫骨的透亮线和骨溶解方面均有相似的结果。此外，两组总体并发症发生率无统计学差异。值得注意的是，非骨水泥 TKA 组有 1 例患者因假体周围感染需要翻修作为终点。
这种新型 3D 打印多孔金属非骨水泥 TKA 在早期与骨水泥 TKA 相比具有相似的临床结果和初始固定。需要更长期的检查来验证这些结果。
