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膝关节置换术，国产假体与进口假体的安全性和效果的差异，需要最新的临床研究结果
在膝关节置换术中，关于国产假体与进口假体的安全性和效果的比较是一个备受关注的话题。本文将结合最新的临床研究结果，包括前述材料中提到的相关研究，分析这两种假体的临床表现。
1. 最新研究概述
国产假体的研究
在一项关于国内机器人辅助的膝关节置换术的多中心随机对照试验中，尽管手术总时间和股骨骨切除的时间显著较传统方法长，而在其他参数如胫骨骨切除时间和术中出血量上则无显著差异。研究表明，在术后90天内，膝关节的功能评分（如KSS和WOMAC）显示在两组之间没有显著差别，但KSS评分的改善率在试验组明显高于对照组，这暗示国产假体可能在功能恢复上具备一定的优势。此外，放射学结果显示，试验组的下肢对齐恢复的精确度显著高于对照组，这为国产假体在整体对齐精度及功能恢复方面提供了数据支持。
进口假体的研究
关于进口假体的研究虽然少量，但一般认同进口假体由于其技术成熟和材料优越，其稳定性和耐用性往往更让人放心。现有的临床数据或多或少集中在其长期成功率和患者满意度上。通常，进口假体的临床效果比较集中在较长随访的病例报告中，这些报告强调了进口假体在解决复杂病例中的有效性。
2. 安全性比较
对于安全性的比较，现有证据显示，国产与进口假体在主要并发症的发生率上差异不大。在上述机器人辅助膝关节置换的研究中，术后并发症如下肢血栓形成在两组之间发生的频率相似。这意味着在安全性上，国产假体也能够达到相对较高的标准。不过，进口假体由于其长期使用记录，医生和患者可能会对其持有更高的信任度。
3. 效果比较
在效果方面，国产假体的临床表现依赖于具体的手术方法及术后管理。机器人辅助技术的应用，使得国产假体在手术精度和下肢对齐方面显示出良好的效果。尽管目前的数据在样本和长期随访方面还稍显不足，但已有研究结果显示，国产假体在短期内的康复效果能够与进口假体相媲美。
同时，进口假体由于其先进的生物材料和设计理念，能够在一定程度上提供更好的稳定性和耐用性。长期随访的数据通常显示，使用进口假体的患者在功能、疼痛和满意度评估上有较高的结果。因此，从长远来看，进口假体可能在这些方面表现得更为优异。
4. 结论
整体来看，虽然现有证据表明国产假体在安全性和短期效果上能基本与进口假体相当，甚至在某些方面有所突破，但在长期耐用性和治疗信任度上，进口假体依然占有优势。进一步的、多中心的大规模随机对照试验将有助于更全面地评估国产与进口假体的差异，特别是在长期结果和复杂病例的表现方面。
随着材料科学的进步和国产医疗器械技术的发展，预计未来国产假体的临床表现将不断接近甚至超过进口假体，提供患者更为经济、有效的治疗选择。同时，医疗体系对国产假体的推广及信任提升，也将助力其在市场上的认可度和应用范围扩大。
References
1Migration of cementless total knee arthroplasty is mitigated by both local intraoperative zoledronate and postoperative denosumab: a randomized controlled trial.PubMed
Karina Nørgaard Linde, Søren Rytter, Bente Lomholt Langdahl, et al.
Bone Joint J. 2025 Aug 1;107-B(8):793-803. doi: 10.1302/0301-620X.107B8.BJJ-2024-1376.R1.
AIMS: The aim of this study was to investigate if adjuvant treatment with antiresorptive bone medication improves fixation of cementless total knee arthroplasty. We hypothesized that local bisphosphonate (zoledronate) or systemic denosumab would both decrease implant migration. METHODS: This four-way, double-blinded, randomized trial included 108 patients with primary knee osteoarthritis with a five-year follow-up. Three groups had the same cementless total knee tibial implant and were included in this primary study (n = 82). Patients were randomized to either placebo (n = 27), intraoperative local zoledronate (n = 28), or postoperative denosumab (n = 27). The primary outcome was tibial implant migration measured by radiostereometric analysis (RSA) using maximum total point motion (MTPM) and signed migrations. Secondary outcomes were biochemical bone markers (resorption: serum collagen type 1 cross-linked C-telopeptide (CTX); formation: serum type 1 procollagen N-terminal (P1NP)), periprosthetic bone mineral density (BMD), and patient-reported outcomes. RESULTS: At one year, the mean difference in MTPM between zoledronate and placebo was 0.43 mm (95% CI 0.01 to 0.85; p = 0.043), and 0.42 mm (95% CI 0.00 to 0.83; p = 0.048) between denosumab and placebo. At five years, the intervention groups showed less y-translation (subsidence) than placebo: mean difference of 0.50 mm for zoledronate (95% CI 0.23 to 0.78; p < 0.001) and 0.30 mm for denosumab (95% CI 0.03 to 0.58; p = 0.031). CTX was lower in the zoledronate group than in the placebo group at two- and six-week follow-up. In the denosumab group, CTX was lower until one year postoperatively. P1NP were similar in the placebo and zoledronate groups, but lower in the denosumab group up to one year postoperatively. Periprosthetic BMD was higher in intervention groups, with a lasting effect in the zoledronate group at five years. CONCLUSION: Both interventions decreased cementless tibial implant migration by suppressing bone resorption. Local zoledronate had a lasting mitigating effect on subsidence and the periprosthetic BMD. Our findings support the use of local intraoperative zoledronate during knee arthroplasty surgery to improve cementless tibial implant fixation and preserve tibial bone. However, multicentre studies and prospective cohort quality studies should be performed for confirmation.
2[A multicenter randomized controlled trial of domestic robot-assisted and conventional total knee arthroplasty].PubMed
Yicheng Li, Xiaogang Zhang, Li Cao, et al.
Zhongguo Xiu Fu Chong Jian Wai Ke Za Zhi. 2023 Nov 15;37(11):1326-1334. doi: 10.7507/1002-1892.202307078.
OBJECTIVE: To investigate the accuracy, safety, and short-term effectiveness of a domestic robot-assisted system in total knee arthroplasty (TKA) by a multicenter randomized controlled trial. METHODS: Between December 2021 and February 2023, 138 patients with knee osteoarthritis who received TKA in 5 clinical centers were prospectively collected, and 134 patients met the inclusion criteria were randomly assigned to either a trial group ( =68) or a control group ( =66). Seven patients had lost follow-up and missing data, so they were excluded and the remaining 127 patients were included for analysis, including 66 patients in the trial group and 61 patients in the control group. There was no significant difference ( >0.05) in gender, age, body mass index, side, duration of osteoarthritis, Kellgren-Lawrence grading, preoperative Knee Society Score (KSS) and Western Ontario and McMaster University Osteoarthritis Index (WOMAC) score between the two groups. The trial group completed the TKA by domestic robot-assisted osteotomy according to the preoperative CT-based surgical planning. The control group was performed by traditional osteotomy plate combined with soft tissue release. Total operation time, osteotomy time of femoral/tibial side, intraoperative blood loss, and postoperative complications were recorded and compared between the two groups. The radiographs were taken at 5 and 90 days after operation, and hip-knee-ankle angle (HKA), lateral distal angle of femur (LDFA), and posterior tibial slope (PTS) were measured. The difference between the measured values of the above indexes at two time points after operation and the preoperative planning target values was calculated, and the absolute value (absolute error) was taken for comparison between the two groups. The postoperative recovery of lower limb alignment was judged and the accuracy was calculated. KSS score and WOMAC score were used to evaluate the knee joint function of patients before operation and at 90 days after operation. The improvement rates of KSS score and WOMAC score were calculated. The function, stability, and convenience of the robot-assisted system were evaluated by the surgeons. RESULTS: The total operation time and femoral osteotomy time of the trial group were significantly longer than those of the control group ( <0.05). There was no significant difference in the tibial osteotomy time and the amount of intraoperative blood loss between the two groups ( 0.05). The incisions of both groups healed by first intention after operation, and there was no infection around the prosthesis. Nine patients in the trial group and 8 in the control group developed lower extremity vascular thrombosis, all of which were calf intermuscular venous thrombosis, and there was no significant difference in the incidence of complications ( >0.05). All patients were followed up 90 days. There was no significant difference in KSS score and WOMAC score between the two groups at 90 days after operation ( >0.05). There was significant difference in the improvement rate of KSS score between the two groups ( <0.05), while there was no significant difference in the improvement rate of WOMAC score between the two groups ( >0.05). Radiological results showed that the absolute errors of HKA and LDFA in the trial group were significantly smaller than those in the control group at 5 and 90 days after operation ( <0.05), and the recovery accuracy of lower limb alignment was significantly higher than that in control group ( <0.05). The absolute error of PTS in the trial group was significantly smaller than that in the control group at 5 days after operation ( <0.05), but there was no significant difference at 90 days between the two groups ( >0.05). The functional satisfaction rate of the robot-assisted system was 98.5% (65/66), and the satisfaction rates of stability and convenience were 100% (66/66). CONCLUSION: Domestic robot-assisted TKA is a safe and effective surgical treatment for knee osteoarthritis, which can achieve favorable lower limb alignment reconstruction, precise implant of prosthesis, and satisfactory functional recovery.