De l'Yvette Private Hospital, 67, route de Corbeil, 91160 Longjumeau, France.
Orthop Traumatol Surg Res. 2010 Nov;96(7):769-76. doi: 10.1016/j.otsr.2010.06.006. Epub 2010 Oct 8.
This multicenter prospective study objective is to provide midterm results and 10-year survival analysis of the original Natural Knee-I System™ as experienced by a group of surgeons performing, within various settings, primary total knee replacement (TKR) in the general population.
The midterm experience with this TKR system in the hands of independent surgical teams can duplicate the satisfaction level that was already published by the designer's group itself.
Two hundred and sixty-three primary TKR were performed by seven surgical teams (37 surgeons) and prospectively evaluated in four European countries. Mean age of the 263 patients (sex ratio, 2.7 females/1 male) was 69 years (range, 35-92) and diagnosis was primary osteoarthritis in 85%. For the 247 TKR with complete operative data, the approach was subvastus in 59%, posterior cruciate ligament was spared in 78%, patella was resurfaced in 56%, and 79% of reconstructions were totally cement-free. Fixation mode was only depending on the surgeon's choice.
At 76 months average follow-up (range 24-190 months), modified Hospital for Special Surgery knee mean score improved from 48 points preoperatively to 83 points. Four reoperations and five revision procedures were required for eight knees. Over the 14-year survey period, the overall revision rate burden was 2% and revision rate per 100 observed component/year, 0.32. At 10 years, survivorship (with revision for aseptic loosening as its end-point [two fully cementless knees]) was 98.6%.
Both this multicenter study and data drawn from national registers provided outcomes with equivalent level of satisfaction at equivalent follow-up to those reported by the NK-I prosthesis designer. There was no significant difference between revision rates of cemented, hybrid or cementless reconstructions.
In non-designer orthopaedists' hands, the Natural Knee-I System™, either with cemented or cementless fixation, provided satisfying midterm results as normally expected in primary TKR with such a modern modular prosthesis.
Level IV. Prospective study.
本多中心前瞻性研究的目的是提供一组外科医生在各种环境下对普通人群进行初次全膝关节置换（TKR）时使用原始 Natural Knee-I System™ 的中期结果和 10 年生存率分析。
在独立手术团队手中，这种 TKR 系统的中期经验可以复制设计者团队本身已经发表的满意度水平。
由七名外科医生组成的七个手术团队对 263 例初次 TKR 进行前瞻性评估，并在四个欧洲国家进行评估。263 例患者的平均年龄（性别比例，2.7 名女性/1 名男性）为 69 岁（范围 35-92 岁），诊断为原发性骨关节炎 85%。对于 247 例具有完整手术数据的 TKR，入路为 59%的髌旁内侧入路，78%保留后交叉韧带，56%髌骨表面置换，79%的重建为完全非骨水泥固定。固定模式仅取决于外科医生的选择。
在 76 个月的平均随访期（24-190 个月），改良的特殊外科医院膝关节平均评分从术前的 48 分提高到 83 分。8 例膝关节需要进行 4 次翻修手术和 5 次翻修手术。在 14 年的调查期间，总翻修率负担为 2%，每 100 个观察到的组件/年的翻修率为 0.32。在 10 年时，存活率（以无菌性松动为终点[两个完全非骨水泥固定的膝关节]）为 98.6%。
这项多中心研究和来自国家登记处的数据都提供了与 NK-I 假体设计者报告的结果等效的满意度水平，随访时间相同。在骨水泥固定、混合固定或非骨水泥固定重建之间，翻修率没有显著差异。
在非设计者骨科医生手中，Natural Knee-I System™ 无论是采用骨水泥固定还是非骨水泥固定，都能为初次 TKR 提供令人满意的中期结果，这在使用这种现代模块化假体时是可以预期的。
IV 级。前瞻性研究。
