Mandl Leonhard, Gruber Alfred, Horch Raymund E, Demir Resit
Universitätsklinikum Erlangen, Erlangen, Germany.
Medical Centre Demir, Nuernberg Germany, Germany.
Arch Orthop Trauma Surg. 2025 Jul 30;145(1):389. doi: 10.1007/s00402-025-06005-5.
In the management of degenerative osteoarthritis and rheumatoid arthritis of the wrist, surgical intervention remains an important treatment option when conservative approaches such as medication, physiotherapy, and assistive devices prove insufficient. Despite decades of development, no single wrist prosthesis has yet emerged as the definitive standard in total wrist arthroplasty. To address this gap, the German Society for Hand Surgery established the Total Endoprosthesis (TEP) Register in 2004 to systematically collect and evaluate long-term clinical outcomes. The present prospective single-centre study analyses and presents the long-term results of patients enrolled in the TEP register, offering valuable insights into the performance and durability of wrist prostheses in a real-world clinical setting.
PATIENTS/MATERIALS/METHODS: Between 2000 and 2011, a total of 29 total endoprostheses were implanted in 25 patients in a single centre study due to severe degenerative changes in the wrist. Of these, 22 had rheumatoid arthritis and 3 degenerative osteoarthritis. The prosthesis models BIAX (N = 13) and Universal II (N = 16) were implanted. The present study describes the mean outcome after a mean observation period of 13.8 (1.7-21.4) years for the BIAX prosthesis and 10.5 years (0.2-16.4) for the Universal II prosthesis.
The probability of survival after 15 years is 60% for the BIAX prosthesis and 41% for the Universal II prosthesis. After 21 years, results are only available for the BIAX prosthesis with a value of 60%. The BIAX prosthesis showed a lower complication rate. Subjectively, 15 years postoperatively, the BIAX prosthesis showed a lower mean value in the QuickDASH score (BIAX 33.8%, Universal II 50.3%), lower results in the visual analogue pain scale under stress (BIAX: 1 point; Universal II: 3 points) with higher patient satisfaction (BIAX: 86%; Universal II: 78%).
In conclusion, our observations show that the BIAX prosthesis is superior to the Universal II prosthesis 15 years after surgery in terms of survival probability, complication rate and better results in satisfaction, the visual analogue pain scale and the QuickDASH score.
在手腕退行性骨关节炎和类风湿性关节炎的治疗中，当药物治疗、物理治疗和辅助器械等保守方法被证明不足时，手术干预仍是一种重要的治疗选择。尽管经过了几十年的发展，但在全腕关节置换术中，尚未有一种单一的腕关节假体成为明确的标准。为了填补这一空白，德国手外科学会于2004年建立了全内置假体（TEP）登记处，以系统地收集和评估长期临床结果。本前瞻性单中心研究分析并展示了登记在TEP登记处的患者的长期结果，为腕关节假体在实际临床环境中的性能和耐用性提供了有价值的见解。
患者/材料/方法：在2000年至2011年期间，在一项单中心研究中，由于手腕严重退行性变，共25例患者植入了29个全内置假体。其中，22例患有类风湿性关节炎，3例患有退行性骨关节炎。植入了假体型号BIAX（N = 13）和通用II型（N = 16）。本研究描述了BIAX假体平均观察期13.8（1.7 - 21.4）年和通用II型假体平均观察期10.5年（0.2 - 16.4）后的平均结果。
BIAX假体15年后的生存率为60%，通用II型假体为41%。21年后，仅获得了BIAX假体的结果，值为60%。BIAX假体的并发症发生率较低。主观上，术后15年，BIAX假体在QuickDASH评分中的平均值较低（BIAX为33.8%，通用II型为50.3%），在压力下视觉模拟疼痛量表中的得分较低（BIAX：1分；通用II型：3分），患者满意度较高（BIAX：86%；通用II型：78%）。
总之，我们的观察表明，在生存率、并发症发生率以及满意度、视觉模拟疼痛量表和QuickDASH评分方面取得更好结果方面，BIAX假体在术后15年优于通用II型假体。
