Department of Orthopaedics, University of Utah, Salt Lake City, Utah.
J Arthroplasty. 2019 Sep;34(9):1957-1962. doi: 10.1016/j.arth.2019.04.030. Epub 2019 Apr 20.
Given the need for continued post-market surveillance, especially on novel implants, the present study attempts to determine the 3-year survivorship and patient-reported outcomes of a contemporary bicruciate-retaining total knee arthroplasty design, and to determine if a learning curve existed which could explain previously reported revision rates.
We performed a retrospective review on a consecutive series of 141 bicruciate-retaining total knee arthroplasties performed at our institution between May 2013 and October 2015. Thirty-four knees (19%) missing 2-year follow-up were excluded. Mean follow-up was 3 years (range 0.34-4.9). Patients who died (n = 5) or were revised prior to 2 years (n = 6) were included. A Kaplan-Meier analysis was used to evaluate revision-free survival.
Survivorship at 3 years was 88% (82%-93%). Revisions were for isolated tibial loosening (5/19), anterior cruciate ligament (ACL) impingement (3/19), pain (4/19), unknown reasons (3/19), femoral and tibial loosening (2/19), ACL deficiency (1/19), and arthrofibrosis (1/19). The mean physical function computerized adaptive test T-score was 45 units (range 23-63). The mean T-scores for Patient-Reported Outcomes Measurement Information System Global measures were 49 (range 27-68) for physical health, 50 (range 28-68) for mental health, and a median 3 (interquartile range 1-8) on the numeric pain scale.
Revision-free survival of 88% at 3 years was lower than existing traditional TKA designs. The primary failure mechanisms were tibial loosening, ACL impingement, and pain. In the setting of higher than anticipated revision rates, despite patient-reported outcomes that are not different than seen in the general population, it is possible that further refinement in implant design or surgical technique may be needed prior to widespread use of this, or similar implant designs.
鉴于需要持续进行上市后监测，尤其是对新型植入物的监测，本研究旨在确定一种新型保留双交叉韧带的全膝关节置换设计的 3 年生存率和患者报告的结果，并确定是否存在可以解释先前报告的翻修率的学习曲线。
我们对 2013 年 5 月至 2015 年 10 月在我们机构进行的连续 141 例保留双交叉韧带的全膝关节置换患者进行了回顾性研究。34 例（19%）因缺失 2 年随访而被排除。平均随访时间为 3 年（0.34-4.9 年）。包括死亡（n=5）或在 2 年前翻修的患者（n=6）。使用 Kaplan-Meier 分析评估无翻修生存率。
3 年生存率为 88%（82%-93%）。翻修的原因包括单纯胫骨松动（5/19）、前交叉韧带（ACL）撞击（3/19）、疼痛（4/19）、原因不明（3/19）、股骨和胫骨松动（2/19）、ACL 缺失（1/19）和关节纤维粘连（1/19）。计算机自适应测试物理功能 T 评分的平均得分为 45 分（范围 23-63）。患者报告的结局测量信息系统总体评分的平均 T 评分分别为 49 分（范围 27-68）用于评估生理健康，50 分（范围 28-68）用于评估心理健康，数字疼痛量表中位数为 3（四分位距 1-8）。
3 年时无翻修生存率为 88%，低于现有的传统 TKA 设计。主要的失败机制是胫骨松动、ACL 撞击和疼痛。在翻修率高于预期的情况下，尽管患者报告的结果与一般人群没有不同，但在广泛应用这种或类似的植入物设计之前，可能需要进一步改进植入物设计或手术技术。
