A Novel Alloplastic Patient Specific Temporalis Tendon Enthesis

Alexandria University

Status and phase: Completed; Phase 2

Conditions: Mandibular Resection

Treatments: Device: Patient specific reconstruction plate for patients suffering from mandibular segmental defects

Study type: Interventional

Funder types: Other

Identifiers

NCT06770868

0118-21/24

Details and patient eligibility

About

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.

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• Composite mandibular defect.
• Malignant lesions that required postoperative adjunctive therapies (CT or RT).

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

Patient specific reconstruction plate for patients suffering from mandibular segmental defects

Experimental group

Description:

Patients with mandibular segmental defect including coronoidectomy managed with patient specific reconstruction plate with custom made temporalis tendon enthesis

Treatment:

Device: Patient specific reconstruction plate for patients suffering from mandibular segmental defects