Patient Specific PEEK Implants for Immediate Restoration of Temporal Fossa After Maxillary Reconstruction With Temporalis Muscle Flap

Cairo University (CU)

Status: Completed

Conditions: Temporal Hollowing

Treatments: Procedure: Temporal PEEK implant

Study type: Interventional

Funder types: Other

Identifiers

NCT05240963

OMFS-19715

Details and patient eligibility

About

Study conducted on patients with major maxillary defects indicating the need of reconstruction with full temporalis muscle flap; or any lesion indicating major maxillary resection and immediate reconstruction with total temporalis muscle flap.

For each patient, a patient specific PEEK implant was fabricated, the temporalis muscle was exposed, elevated, and transferred to the maxilla, finally PEEK implants were fixed in place to prevent temporal hollowing.

Full description

Study conducted on patients with major maxillary defects indicating the need of reconstruction with full temporalis muscle flap; or any lesion indicating major maxillary resection and immediate reconstruction with total temporalis muscle flap.

For each patient, a patient specific PEEK implant was fabricated, the temporalis muscle was exposed, elevated, and transferred to the maxilla, finally PEEK implants were fixed in place to prevent temporal hollowing.

Enrollment: 8 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients with major maxillary defects indicating the need of reconstruction with full temporalis muscle flap; or any lesion indicating major maxillary resection and immediate reconstruction with total temporalis muscle flap.

Exclusion criteria

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

8 participants in 1 patient group

PEEK implant

Experimental group

Description:

Temporal PEEK implant to prevent temporal hollowing after temporalis muscle transfer

Treatment:

Procedure: Temporal PEEK implant