NCT06770868

A Novel Alloplastic Patient Specific Temporalis Tendon Enthesis

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Alexandria University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Mandibular Resection

Interventions

Type	Name	Description
DEVICE	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

Timeline

• Start date: 2023-02-01
• Primary completion: 2024-02-01
• Completion: 2024-05-18
• First posted: 2025-01-13
• Last updated: 2025-01-13

Locations

1 site across 1 country: Egypt