Unit of Maxillofacial Surgery, Department of Neuroscience, University of Padova, Padova, Italy; Regional Center for the Prevention, Diagnosis and Treatment of Medication and Radiation-related Bone Diseases of the Head and Neck, Azienda Ospedale-Università Padova, Padova, Italy.
Department of Medicine, University of Padova, Via Giustiniani 2, 35128 Padova, Italy.
Oral Oncol. 2021 Jan;112:105073. doi: 10.1016/j.oraloncology.2020.105073. Epub 2020 Nov 5.
We evaluated the safety of REPLICA, a CAD/CAM-designed patient-specific titanium mandible, in patients with mandibular defects not suitable for reconstruction with traditional techniques.
We performed a cohort study with a composite primary outcome assigned at the end of a 1-year follow-up. The outcome was assigned in the presence of all the following: 1) absence of intraoral or skin extrusion of REPLICA; 2) decrease or cessation of oral pain; 3) stability or increase in mouth opening; 4) resumption of oral feeding without the need of nasogastric tube; 5) absence of fracture at multidetector computer tomography (MDCT); 6) absence of displacement (MDCT); 7) absence of screw loosening (MDCT). The secondary outcome was the patient-reported QOL at 6 months of follow-up as detected by the EORTC QLQ-C30 and QLQ-H&N35 questionnaires.
Between March 2012 and June 2017, 18 consecutive patients, with a median (IQR) age of 67 (65;74) underwent reconstruction of mandibular defects with REPLICA at our Unit. The primary outcome was reached by 14 of the 18 patients. QOL data were available for 15 patients at the 6-month follow-up, showing a good profile of general and disease-specific QOL.
REPLICA offered a safe solution at 1-year for the treatment of mandibular defects not suitable for reconstruction with traditional techniques, and was associated with subjective well-being and satisfaction. Further studies are needed to assess the full range of indications of REPLICA.
我们评估了 REPLICA 的安全性，REPLICA 是一种 CAD/CAM 设计的个性化钛质下颌骨，适用于不适合传统技术重建的下颌骨缺损患者。
我们进行了一项队列研究，主要复合终点在 1 年随访结束时评估。如果满足以下所有条件，则评定结果为阳性：1）REPLICA 无口腔内或皮肤外露；2）口腔疼痛减轻或消失；3）张口度稳定或增加；4）无需经鼻胃管即可恢复经口进食；5）多排螺旋 CT（MDCT）未见骨折；6）MDCT 未见移位；7）MDCT 未见螺钉松动。次要终点为 6 个月随访时患者报告的生活质量，通过 EORTC QLQ-C30 和 QLQ-H&N35 问卷检测。
2012 年 3 月至 2017 年 6 月，我们单位连续收治了 18 例接受 REPLICA 重建下颌骨缺损的患者，中位（IQR）年龄为 67（65；74）岁。18 例患者中有 14 例达到了主要终点。15 例患者在 6 个月随访时获得了 QOL 数据，显示出良好的一般和疾病特异性 QOL 状况。
REPLICA 在 1 年时为不适合传统技术重建的下颌骨缺损患者提供了一种安全的治疗方法，与主观幸福感和满意度相关。需要进一步的研究来评估 REPLICA 的全部适应证。
