A Novel Alloplastic Patient Specific Temporalis Tendon Enthesis for Mandibular Resection with Coronoidectomy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Mandibular Kinematics assessment
研究概览
简要总结
Mandibular reconstruction of segmental defects is an arduous surgical procedure that requires an utmost degree of surgical fidelity. Whether primary bone reconstruction is feasible or not, alloplastic bridging between the remaining bone stumps is mandatory to achieve functional, aesthetic, and symmetrical demands of the lower third of the face. Mandibular reconstructive surgery should be directed toward the maintains of the normal orthognathic centric condylar position, mandibular kinematics, and muscles of mastication function. Mandibular resection with coronoid removal cause imbalance in the attachment of one of the large muscles of mastication, the temporalis muscle. The use of computer-aided surgery allowed the creation of custom made fixation plates with a plethora of advantages over the conventional plates.
the study aims to introduce a novel plate design, which creates an enthsis for the reattachment of the temporalis muscle tendon.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with mandibular lesion that require segmental resection.
- •Patients required coronoid processes resection within the safety margin of the lesion.
- •Brown Class I cases with preservation of the condyle process and no need for alloplastic TMJ replacement.
- •Complaisant patient that is able to complete at least 1 year follow up.
排除标准
- •Composite mandibular defect.
- •Malignant lesions that required postoperative adjunctive therapies (CT or RT).
研究组 & 干预措施
Patient specific reconstruction plate for patients suffering from mandibular segmental defects
Patients with mandibular segmental defect including coronoidectomy managed with patient specific reconstruction plate with custom made temporalis tendon enthesis
干预措施: Patient specific reconstruction plate for patients suffering from mandibular segmental defects (Device)
结局指标
主要结局
Mandibular Kinematics assessment
时间窗: 6 months
range of mandibular excursions were recorded preoperatively (T0) and at 1-postopertive week (T1), 1-postoperative month (T2), 4-postoperative month (T3), 6- postoperative month (T4).
次要结局
- Postoperative temporalis muscle activity(6 months)
