目的:为了治疗膝关节骨性关节炎(OA),可以使用定制的交叉保留全膝关节置换术(CCR-TKA)系统,包括个性化的仪器和植入物。这项单中心队列研究的目的是分析植入第二代定制植入物的一系列患者的患者报告和功能结果。
方法:在我们的关节成形术中心,我们前瞻性招募了一组接受全膝关节置换(TKA)治疗的三房性关节炎患者,这些患者采用定制的交叉保留(CCR)植入物设计.患者的纳入标准包括存在完整的后交叉韧带和副韧带,以及仅限于<15°内翻的膝关节畸形。外翻,或屈曲挛缩。评估患者的运动范围(ROM),膝关节社会评分(KSS),西安大略省和麦克马斯特大学骨关节炎指数(WOMAC),和简短形式(SF)-12的身体和心理分数,术前,在3个月和6个月时,以及术后1、2、3和5年的随访(FU)。
结果:患者的平均年龄为64岁(范围:40-81),平均BMI为31(范围:23-42),总的来说,包括28名女性和45名男性患者。平均随访2.5年,植入物存活率为97.5%(一次败血症松动)。KSS膝关节和功能评分明显改善(p<0.001),分别,术前访视的41和53,分别为92和86,在术后5年的时间点。在5年FU时,SF-12的身体和心理评分显着(p<0.001)从术前的28和50提高到50和53,分别。患者的膝关节整体活动范围有了显着改善,从术前就诊的106°到122°,平均而言,术后5年。在5年FU时,WOMAC总分从术前的49.1显著(p<0.001)提高到术后的11.4。
结论:尽管本研究中没有与其他植入物进行比较,患者在手术后的第一年内报告了较高的总体满意度和功能结局的改善,这种情况在接下来的几年里一直持续着。这些中期结果与当前文献中报道的结果相比是极好的。需要使用该设备进行长期比较研究。证据水平3b(个别病例对照研究)。
OBJECTIVE: 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.
METHODS: 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.
RESULTS: 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 (p < 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 (p < 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 (p < 0.001) improved from 49.1 preoperatively to 11.4 postoperatively at 5-year FU.
CONCLUSIONS: 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).