Hack J, Mai S, Siebert W
Vitos Orthopädische Klinik Kassel.
Z Orthop Unfall. 2015 Oct;153(5):508-15. doi: 10.1055/s-0035-1546040. Epub 2015 May 20.
The purpose of this study was to evaluate long-term clinical and radiological results as well as survival rates of the NexGen® CR posterior cruciate retaining prosthesis.
We evaluated a consecutive series of 761 total knee replacements performed on 716 patients from 1999 to 2001 at our institution. All patients had been recorded prospectively in our in-house arthroplasty register. Follow-up data were available for 379 patients at 10 years postoperatively. Functional outcome was evaluated using the Knee Society score. An additional radiographic evaluation was performed on 224 patients at 10 years. The mean age of the patients at the time of surgery was 71 years. 75 % of the patients were female, 25 % were male. Mean BMI of the patients was 29.2 kg/m(2). The preoperative diagnosis was osteoarthritis in 91 %, rheumatoid arthritis in 5,5 % and posttraumatic osteoarthritis in 2 %. Patella resurfacing was performed in 4 %. All components were cemented.
Mean Knee Society clinical score improved from 26.7 points preoperatively to 88.5 points at the time of the latest follow-up, and mean Knee Society function score improved from 48.3 to 55.2 points. Flexion improved from a mean of 106.7° preoperatively to 111.4° at 10 years. Patellofemoral pain was indicated by 66 % of the patients before surgery and 4 % at the latest follow-up. 96 % were satisfied with the result of the surgery at 10 years. Radiographic evaluation was performed on 224 patients at the time of the latest follow-up. 203 patients (91 %) had normal radiographic findings, 21 patients (9 %) showed pathological findings. Radiolucencies were seen in 18 patients on the AP view of the tibia, 1 patient had an additional femoral radiolucency. There was an osteolysis located in the lateral tibia seen in 1 patient and an occurrence of heterotopic ossification in another patient. One knee showed a patella subluxation. No patient had radiographic evidence of loosening. 17 knees had required revision surgery with exchange of at least one of the components up to 10 years after the index procedure. 5 of the patients had revision for a deep infection, 2 for periprosthetic fractures of the distal femur with loosening of the prosthesis, 1 for fracture of the proximal tibia due to osteoporosis, 4 for aseptic loosening, 3 for instability and 2 for severe pain. Kaplan-Meier survival of all components using revision for any reason as the end point was 97.8 % at 10 years.
The good clinical and radiological long-term results as well as the satisfactory survival rate after total knee replacement with the NexGen CR® prosthesis are comparable with the results of other long-term studies using the NexGen CR® and assimilable prosthesis. Our results demonstrate that quality of life was improved by the implantation of the NexGen CR® prosthesis even a long time after the index procedure despite old age and comorbidity of the patients.
本研究旨在评估NexGen® CR后交叉韧带保留型假体的长期临床和影像学结果以及生存率。
我们评估了1999年至2001年在我院对716例患者进行的连续761例全膝关节置换术。所有患者均已前瞻性地记录在我们内部的关节成形术登记册中。术后10年有379例患者的随访数据。使用膝关节协会评分评估功能结果。对224例患者在术后10年进行了额外的影像学评估。手术时患者的平均年龄为71岁。75%的患者为女性，25%为男性。患者的平均体重指数为29.2kg/m²。术前诊断为骨关节炎的占91%，类风湿关节炎的占5.5%，创伤后骨关节炎的占2%。4%的患者进行了髌骨表面置换。所有组件均采用骨水泥固定。
膝关节协会临床评分平均从术前的26.7分提高到最近一次随访时的88.5分，膝关节协会功能评分平均从48.3分提高到55.2分。屈曲角度从术前平均106.7°提高到10年时的111.4°。66%的患者术前有髌股关节疼痛，最近一次随访时为4%。96%的患者对手术10年的结果满意。在最近一次随访时对224例患者进行了影像学评估。203例患者（91%）影像学检查结果正常，21例患者（9%）显示有病理改变。在胫骨前后位片上18例患者可见透亮线，1例患者股骨另有透亮线。1例患者在胫骨外侧有骨溶解，另1例患者发生了异位骨化。1例膝关节出现髌骨半脱位。没有患者有假体松动的影像学证据。在初次手术术后10年内，有17例膝关节需要进行翻修手术，至少更换一个组件。5例患者因深部感染进行翻修，2例因股骨远端假体周围骨折伴假体松动进行翻修，1例因骨质疏松导致胫骨近端骨折进行翻修，4例因无菌性松动进行翻修，3例因不稳定进行翻修，2例因严重疼痛进行翻修。以任何原因进行翻修为终点，所有组件的Kaplan-Meier 10年生存率为97.8%。
使用NexGen CR®假体进行全膝关节置换术后良好的长期临床和影像学结果以及令人满意的生存率，与使用NexGen CR®和类似假体的其他长期研究结果相当。我们的结果表明，尽管患者年龄较大且存在合并症，但即使在初次手术很长时间后，植入NexGen CR®假体仍可改善生活质量。
