METHODS: Consecutive series of adult patients underwent TEA using the Nexel by a single surgeon via standardized technique. Patients with minimum 3-year follow-up with radiographic and PROM data were included. Survivorship was defined by the absence of revision. Loosening was assessed via the Wrightington method by 3 independent fellowship-trained shoulder and elbow surgeons. Lucency was analyzed across individual radiographic zones on orthogonal radiographs. PROMs included the Quick Disabilities of the Arm, Shoulder, and Hand questionnaire (QuickDASH), Patient-Rated Elbow Evaluation (PREE), and EuroQoL-5 Dimensions (EQ-5D).
RESULTS: Thirty-eight consecutive patients (22 female, 16 male) with a mean age of 67 years underwent TEA via a triceps-sparing isolated medial window approach. Mean follow-up was 5.5 years (range 3-9). Primary diagnoses were as follows: 19 osteoarthritis (OA), 9 rheumatoid arthritis (RA), 9 post-traumatic arthritis (PA), and 1 conversion of elbow arthrodesis. Overall survivorship was 97.4%, with 1 patient undergoing revision for infection. Loosening was found in 5.3% of elbows, averaged across 3 observers. Lucency was most pronounced at the level of the humeral condyles. PROMs demonstrated significant and clinically meaningful improvements in 76%, 92%, and 73% of patients for QuickDASH, PREE, and EQ-5D, respectively. No significant correlations were found between patient age, gender, loosening, lucency, and PROMs.
CONCLUSIONS: At midterm follow-up, the Nexel TEA demonstrated excellent overall survivorship and low rate of implant loosening. The single failure requiring revision for infection was conversion of a prior elbow arthrodesis. PROMs overall exhibited marked and consistent improvement from preoperative to final postoperative follow-up. Although promising, these results should be interpreted with some caution as long-term data regarding this prosthesis are still lacking.
方法:连续系列的成年患者由一名外科医生通过标准化技术使用Nexel进行TEA。包括至少3年随访的影像学和PROM数据的患者。生存是由缺乏修订定义的。由三名独立的研究金训练的肩和肘外科医生通过Wrightington方法评估松动。在正交射线照相上分析了各个射线照相区的透明度。PROM包括QuickDash(QDASH),患者额定弯头评估(PREE),和欧洲QoL(EQ5D)。
结果:连续38名患者(22名女性,16名男性),平均年龄为67岁,通过保留三头肌的孤立内侧窗方法接受了TEA。平均随访5.5年(范围3-9)。主要诊断为:19骨关节炎(OA),9类风湿性关节炎(RA),9创伤后关节炎(PA),1肘关节固定术的转换。总生存率为97.4%,一名患者因感染而接受翻修。5.3%的肘部出现松动,三个观察者的平均值。清醒在肱骨髁上最为明显。PROM显示出76%的显着和临床意义的改善,92%,73%的患者接受QDASH治疗,PREE,和EQ5D,分别。患者年龄之间没有发现显著的相关性,性别,松开,清醒,和PROMs。
结论:在中期随访时,NexelTEA显示出优异的总体生存率和较低的植入物松动率。需要翻修感染的单一失败是先前肘关节固定术的转换。从手术前到最终的手术后随访,PROM总体上表现出明显且一致的改善。虽然很有希望,这些结果应谨慎解释,因为仍缺乏有关该假体的长期数据.