Mercuri Louis G, Wolford Larry M, Sanders Bruce, White R Dean, Giobbie-Hurder Anita
Professor of Surgery, Division of Oral and Maxillofacial Surgery, Department of Surgery, Stritch School of Medicine, Loyola University Medical Center, Maywood, IL 60153, USA.
J Oral Maxillofac Surg. 2002 Dec;60(12):1440-8. doi: 10.1053/joms.2002.36103.
The purpose of this study was the assessment of the long-term safety and effectiveness of the Techmedica (Camarillo, CA) CAD/CAM Total Temporomandibular Joint Reconstruction System (now called the TMJ Concepts Patient Fitted Total Temporomandibular Joint Reconstruction System, Ventura, CA).
A survey was mailed to the available addresses of 170 (79%) of the 215 patients who had been implanted with the Techmedica System devices between 1990 and 1994. Seventy-nine (46%) surveys were returned by the US Postal Service as undeliverable. Three patients (1.4%) were reported as deceased in returns from relatives. Therefore, of the remaining 91 possible responses, 60 (65.9%) were returned. Fifty-eight (58) surveys, considered complete and valid (96.7%), representing 97 (39 bilateral, 19 unilateral) devices with a mean follow-up of 107.4 +/- 15.5 months (range, 60 to 120 months) were analyzed. Subjective data related to pain, mandibular function, diet consistency, and present quality of life were collected using visual analog scales. Objective measures of mandibular interincisal opening and lateral excursions were obtained from direct measurements using the Therabite (Therabite, Philadelphia, PA) measuring scale provided in the survey with instructions as to its use.
Analysis of the subjective data at 10 years revealed a 76% reduction in mean pain scores and a 68% increase in mean mandibular function and diet consistency scores (P <.0001). Analysis of objective data revealed a 30% improvement in mandibular range of motion after 10 years (P =.0009). Long-term quality of life improvement scores were statistically related to the number of prior temporomandibular joint operations the patients had undergone.
These data indicate that the CAD/CAM Patient Fitted Total Temporomandibular Joint Reconstruction System has proved to be a safe and effective long-term management modality in the patient population surveyed for this study.
本研究旨在评估Techmedica公司（加利福尼亚州卡马里奥）的计算机辅助设计/计算机辅助制造全颞下颌关节重建系统（现称为TMJ Concepts患者定制全颞下颌关节重建系统，加利福尼亚州文图拉）的长期安全性和有效性。
向1990年至1994年间植入Techmedica系统装置的215例患者中的170例（79%）的有效地址邮寄了调查问卷。美国邮政服务部门退回了79份（46%）无法投递的问卷。亲属回复中报告有3例患者（1.4%）已去世。因此，在其余91份可能的回复中，有60份（65.9%）被退回。对58份被认为完整且有效的问卷（96.7%）进行了分析，这些问卷代表了97个装置（39个双侧，19个单侧），平均随访时间为107.4±15.5个月（范围为60至120个月）。使用视觉模拟量表收集了与疼痛、下颌功能、饮食稠度和当前生活质量相关的主观数据。下颌切牙间开口度和侧向运动的客观测量数据是通过使用调查问卷中提供的Therabite测量量表（宾夕法尼亚州费城，Therabite公司）直接测量获得的，并附有使用说明。
对10年时的主观数据进行分析发现，平均疼痛评分降低了76%，平均下颌功能和饮食稠度评分提高了68%（P<.0001）。对客观数据进行分析发现，10年后下颌运动范围改善了30%（P =.0009）。长期生活质量改善评分与患者先前接受的颞下颌关节手术次数在统计学上相关。
这些数据表明，对于本研究调查的患者群体而言，计算机辅助设计/计算机辅助制造患者定制全颞下颌关节重建系统已被证明是一种安全有效的长期治疗方式。
