Cournapeau J, Klouche S, Bauer T, Hardy P
Hôpitaux Universitaires Paris Île-de-France Ouest, AP-HP, 92100 Boulogne-Billancourt, France.
Hôpitaux Universitaires Paris Île-de-France Ouest, AP-HP, 92100 Boulogne-Billancourt, France.
Orthop Traumatol Surg Res. 2015 Jun;101(4):455-60. doi: 10.1016/j.otsr.2015.01.016. Epub 2015 Apr 29.
Fixed-bearing total knee arthroplasty (TKA) implants have excellent long-term survival. Mobile-bearing implants were developed to reduce bone-implant interface stresses and polyethylene insert wear. The primary objective of this study was to analyze the survival rate of a highly congruent mobile-bearing TKA implant (Ceragyr(®)) in patients having a minimum follow-up of 7 years. We hypothesized that the survival rate would be 95-100% at that time point.
A single-center prospective study included all the patients operated for a primary TKA procedure with a Ceragyr(®) implant between 2000 and 2003. All the implants were cemented. Patellar resurfacing was not carried out systematically, but could be carried out secondarily in cases of persistent anterior knee pain. Clinical and radiological data were collected before the surgery, at 3 months postoperative, at 1 year and then at a minimum follow-up of 7 years. The primary endpoint was the overall revision-free survival rate. Secondary endpoints were the survival without mechanical failure, IKS scores, knee range of motion and implant positioning.
One hundred and thirty-four patients (143 Ceragyr(®) TKA cases) were included; 9 patients (10 TKA) were lost to follow-up (6.7%) and the remaining 125 patients (133 TKA) were contacted. At the final review, 7 of the 133 TKA cases (5.3%) had been revised (6 men, 1 women; P = 0.002), 2 (1.5%) because of mechanical failure and 5 (3.8%) because of an infection. The overall revision-free survival rate was 94.8% [95% CI: 89.3-97.5]; survival was 98.4% [95% CI: 93.8-99.6] with mechanical failure as an endpoint. An in-person assessment was conducted on 76 patients (80 TKA cases) (49 women; 27 men) who had an average age of 70.3 ± 8.4 years at the time of the arthroplasty procedure. The patella had been resurfaced during the initial procedure in 49 cases, and was either not resurfaced or secondarily resurfaced in 31 cases. The average follow-up was 8.7 ± 1.1 years. The IKS score had significantly improved relative to the preoperative values (P < 0.00001). Knee flexion and the IKS knee score remained stable over time (P > 0.05). Patients who underwent patella resurfacing during the initial TKA procedure had better clinical results (P = 0.03).
After a minimum follow-up of 7years, the overall revision-free survival rate for the Ceragyr(®) was 94.8%; the survival was 98.4% with mechanical failure as an endpoint. The results were stable over time.
固定承重全膝关节置换术（TKA）植入物具有出色的长期生存率。活动承重植入物的研发旨在降低骨-植入物界面应力以及聚乙烯衬垫磨损。本研究的主要目的是分析高度匹配的活动承重TKA植入物（Ceragyr®）在至少随访7年的患者中的生存率。我们假设在该时间点生存率将为95%至100%。
一项单中心前瞻性研究纳入了2000年至2003年间接受初次TKA手术并使用Ceragyr®植入物的所有患者。所有植入物均采用骨水泥固定。未系统地进行髌骨表面置换，但在持续性膝前疼痛的情况下可二期进行。在手术前、术后3个月、1年以及至少随访7年时收集临床和放射学数据。主要终点是总体无翻修生存率。次要终点是无机械故障生存率、IKS评分、膝关节活动范围和植入物位置。
纳入了134例患者（143例Ceragyr® TKA病例）；9例患者（10例TKA）失访（6.7%），其余125例患者（133例TKA）接受了随访。在最终复查时，133例TKA病例中有7例（5.3%）进行了翻修（6例男性，1例女性；P = 0.002），2例（1.5%）因机械故障，5例（3.8%）因感染。总体无翻修生存率为94.8% [95%置信区间：89.3 - 97.5]；以机械故障为终点的生存率为98.4% [95%置信区间：93.8 - 99.6]。对76例患者（80例TKA病例）（49例女性；27例男性）进行了当面评估，这些患者在关节置换手术时的平均年龄为70.3±8.4岁。49例患者在初次手术时进行了髌骨表面置换，31例患者未进行表面置换或二期进行了表面置换。平均随访时间为8.7±1.1年。IKS评分相对于术前值有显著改善（P < 0.00001）。膝关节屈曲和IKS膝关节评分随时间保持稳定（P > 0.05）。在初次TKA手术时进行髌骨表面置换的患者临床结果更好（P = 0.03）。
至少随访7年后，Ceragyr®的总体无翻修生存率为94.8%；以机械故障为终点的生存率为98.4%。结果随时间保持稳定。
