Afzal Zahid, Umorin Mikhail, Mercuri Louis G, Warburton Gary
Oral and Maxillofacial Surgeon, Private Practice, Birmingham, UK.
Assistant Professor, Department of Biomedical Sciences Texas A&M University, Dallas, TX.
J Oral Maxillofac Surg. 2025 Jan;83(1):10-16. doi: 10.1016/j.joms.2024.10.002. Epub 2024 Oct 11.
Custom-designed and patient-fitted temporomandibular joint replacement (TMJR) devices are used to manage end-stage temporomandibular joint (TMJ) pathology, distorted bony TMJ architecture, or in patients who have undergone multiple prior failed TMJ surgeries.
This study aimed to measure the frequency of revision or replacement over time, estimate the 1-, 2-, and 3-year survival rate of implants, and determine what demographic, anatomical, or operative variables may be associated with a device adverse event (AE).
STUDY DESIGN, SETTING, SAMPLE: A prospective cohort study was conducted on consenting adults who could read English, implanted with the TMJ Concepts TMJR prostheses between 2013 and 2015 by private or academic surgeons. Patients under the age of 18 and those who were incapable, unwilling, or unable to complete the perioperative forms were excluded.
The primary outcome variable was the frequency of AEs, which is defined as device revision or replacement. The secondary outcome variable was the survival rate for the TMJ Concepts devices.
Device survival at 1, 2, and 3 years was estimated using the Kaplan-Meier methodology. Cox proportional hazards regression was used to analyze the effects of the predictor variables for the device survival rate. A P value of <.05 was considered significant.
A total of 738 subjects (1,098 joints) were enrolled in the study with 102 (14%) males and 636 (86%) females. The mean age was 45.4 (+14.8) years. The median follow-up period was 36.2 months (95% CI: 36.1 to 36.2 months). A total of 187 subjects (25.3%) were lost to follow-up during; the study period. Forty-nine devices (4.46%) were associated with an AE at 3 years. The; 3-year device survival was 95.1% (95% CI: 93.6 to 96.3%). The only significant risk factor for an AE was the asymmetry of the mandible (hazard rate ratio = 1.989, P = .03). The primary diagnosis was not associated with the time to an AE (P value = .8685). Infection (44.7%, 21 joints) and material sensitivity (12.8%, 6 joints) were the most common reasons specifically for device removal/replacement in the study cohort.
Infection was the primary reason reported for device revision or replacement followed by material sensitivity. In the study cohort, the device survival following implantation of the TMJ Concepts prosthesis was not significantly different than reported by the TMJR stock device.
定制设计且贴合患者的颞下颌关节置换（TMJR）装置用于治疗终末期颞下颌关节（TMJ）病变、TMJ骨结构畸形，或用于曾多次接受TMJ手术但均失败的患者。
本研究旨在测量随时间推移进行翻修或更换的频率，估计植入物1年、2年和3年的生存率，并确定哪些人口统计学、解剖学或手术变量可能与器械不良事件（AE）相关。
研究设计、设置、样本：对2013年至2015年间由私立或学术外科医生植入TMJ Concepts TMJR假体、能读懂英文且同意参与的成年人进行了一项前瞻性队列研究。排除18岁以下患者以及无法、不愿或不能完成围手术期表格的患者。
主要结局变量是AE的频率，定义为器械翻修或更换。次要结局变量是TMJ Concepts装置的生存率。
使用Kaplan-Meier方法估计1年、2年和3年的器械生存率。采用Cox比例风险回归分析预测变量对器械生存率的影响。P值<.05被认为具有统计学意义。
共有738名受试者（1098个关节）纳入研究，其中男性102名（14%），女性636名（86%）。平均年龄为45.4（±14.8）岁。中位随访期为36.2个月（95%CI：36.1至36.2个月）。在研究期间，共有187名受试者（25.3%）失访。49个器械（4.46%）在3年时与AE相关。3年器械生存率为95.1%（95%CI：93.6至96.3%）。AE的唯一显著风险因素是下颌骨不对称（风险率比=1.989，P=.03）。主要诊断与发生AE的时间无关（P值=.8685）。感染（44.7%，21个关节）和材料敏感性（12.8%，6个关节）是研究队列中器械取出/更换的最常见具体原因。
感染是报告的器械翻修或更换的主要原因，其次是材料敏感性。在研究队列中，植入TMJ Concepts假体后的器械生存率与TMJR库存器械报告的生存率无显著差异。
