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临床试验/NCT06770868
NCT06770868已完成2 期

A Novel Alloplastic Patient Specific Temporalis Tendon Enthesis for Mandibular Resection with Coronoidectomy

Alexandria University1 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2023年2月1日最近更新:
适应症
干预措施

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

Experimental

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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