Steinert Andre F, Schröder Lennart, Sefrin Lukas, Janßen Björn, Arnholdt Jörg, Rudert Maximilian
Department of Orthopaedic Surgery, König-Ludwig-Haus, Julius-Maximilians-University Würzburg, Brettreichstraße 11, D-97074 Würzburg, Germany.
Rhön Klinikum, Campus Bad Neustadt, EndoRhön Center for Joint Replacement, Teaching Hospital of the Phillipps University Marburg, Von Guttenberg Str. 11, D-97616 Bad Neustadt, Germany.
J Pers Med. 2022 Jan 31;12(2):194. doi: 10.3390/jpm12020194.
To treat patients with tricompartimental knee osteoarthritis (OA), a customized cruciate-retaining total knee arthroplasty (CCR-TKA) system can be used, including both individualized instrumentation and implants. The objective of this monocentric cohort study was to analyze patient-reported and functional outcomes in a series of patients implanted with the second generation of this customized implant.
At our arthroplasty center, we prospectively recruited a cohort of patients with tricompartmental gonarthrosis to be treated with total knee replacement (TKA) using a customized cruciate-retaining (CCR) implant design. Inclusion criteria for patients comprised the presence of intact posterior cruciate and collateral ligaments and a knee deformity that was restricted to <15° varus, valgus, or flexion contracture. Patients were assessed for their range of motion (ROM), Knee Society Score (KSS), Western Ontario and McMaster University osteoarthritis index (WOMAC), and short form (SF)-12 physical and mental scores, preoperatively, at 3 and 6 months, as well as at 1, 2, 3, and 5 years of follow-up (FU) postoperatively.
The average age of the patient population was 64 years (range: 40-81), the average BMI was 31 (range: 23-42), and in total, 28 female and 45 male patients were included. Implant survivorship was 97.5% (one septic loosening) at an average follow-up of 2.5 years. The KSS knee and function scores improved significantly ( < 0.001) from, respectively, 41 and 53 at the pre-operative visit, to 92 and 86, respectively, at the 5-year post-operative time point. The SF-12 Physical and Mental scores significantly ( < 0.001) improved from the pre-operative values of 28 and 50, to 50 and 53 at the 5-year FU, respectively. Patients experienced significant improvements in their overall knee range of motion, from 106° at the preoperative visit to 122°, on average, 5 years postoperatively. The total WOMAC score significantly ( < 0.001) improved from 49.1 preoperatively to 11.4 postoperatively at 5-year FU.
Although there was no comparison to other implants within this study, patients reported high overall satisfaction and improvement in functional outcomes within the first year from surgery, which continued over the following years. These mid-term results are excellent compared with those reported in the current literature. Comparative long-term studies with this device are needed. Level of evidence 3b (individual case-control study).
对于患有三髁间膝关节骨关节炎（OA）的患者，可使用定制的保留交叉韧带全膝关节置换术（CCR-TKA）系统，该系统包括个性化器械和植入物。这项单中心队列研究的目的是分析一系列植入第二代这种定制植入物的患者的患者报告结局和功能结局。
在我们的关节置换中心，我们前瞻性招募了一组患有三髁间膝关节病的患者，使用定制的保留交叉韧带（CCR）植入物设计进行全膝关节置换（TKA）治疗。患者的纳入标准包括后交叉韧带和侧副韧带完整，膝关节畸形限于内翻、外翻或屈曲挛缩<15°。在术前、术后3个月和6个月以及术后1、2、3和5年的随访（FU）中，评估患者的活动范围（ROM）、膝关节协会评分（KSS）、西安大略和麦克马斯特大学骨关节炎指数（WOMAC）以及简短健康调查（SF）-12身体和心理评分。
患者人群的平均年龄为64岁（范围：40-81岁），平均BMI为31（范围：23-42），总共纳入了28名女性和45名男性患者。平均随访2.5年时，植入物生存率为97.5%（一例感染性松动）。KSS膝关节和功能评分从术前访视时的分别41分和53分显著提高（<0.001），到术后5年时分别为92分和86分。SF-12身体和心理评分从术前的28分和50分显著提高（<0.001），到5年随访时分别为50分和53分。患者的全膝关节活动范围有显著改善，从术前访视时的106°平均提高到术后5年的122°。WOMAC总分在5年随访时从术前的49.1分显著提高（<0.001）到术后的11.4分。
尽管本研究中未与其他植入物进行比较，但患者报告在术后第一年总体满意度高且功能结局有所改善，并且在接下来的几年中持续改善。与当前文献报道的结果相比，这些中期结果非常出色。需要对该器械进行比较性长期研究。证据水平3b（个体病例对照研究）。
