The Effect of Temporal Muscle Suspension of Temporal Hollowing (TMS)

Johns Hopkins University

Status: Withdrawn

Conditions: Temporal Wasting

Treatments: Procedure: Traditional re-suspension of the temporal muscle; Procedure: Re-Suspension of the temporal muscle after a craniotomy.

Study type: Interventional

Funder types: Other

Identifiers

NCT03324516

IRB00120812

Details and patient eligibility

About

The primary objective is to identify which patients undergoing a traditional pterional approach with 2 different surgical techniques for TMS (Temporal Muscle Suspension) will develop TH (Temporal Hollowing. Pre and post-operative CT scans will be reviewed and analysis with previously proven metrics will be performed.

Full description

The pterional approach is an indicated neurosurgical approach commonly used for anterior circular aneurysms, suprasellar lesions, and medial sphenoid wing tumors (1,2). A curvilinear incision from the midline widows peak and extending laterally to 1 cm anterior to the tragus of the ear, terminating within a skin crease, with preservation of the superficial temporal artery if possible. The temporalis fascia is encountered and divided. Either the entire temporalis muscle can be elevated or a cuff of temporalis muscle can be left on the cranium to facilitate closure and suspend the temporalis muscle. Subperiosteal dissection of the muscle is performed and the craniotomies are then accomplished.

Reconstruction of the pterional approach can be accomplished with bony fixation of the bone flap. However, the TMS can be performed by:

1. Resuspension of the temporalis muscle to the cuff of muscle left on the temporal crest or
2. Suturing the temporalis muscle directly to one of the bone plates that is used to for fixation.

The purpose of this prospective study is see if traditional techniques to the closure and temporal muscle suspension (TMS) after the pterional approach will show any differences in post-operative temporal hollowing (TH).

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• This study will include all patients over the age of 18 years who qualify for a pterional approach for their neurosurgical pathology.

Exclusion criteria

• Excluded patients will be protected populations, such as inmates or children. Patients will not be excluded on the basis of pregnancy.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Experimental Group

Experimental group

Description:

Patients included in this arm will undergo a traditional bony pterional approach for their craniotomy. A superior cuff of temporal muscle will be left attached to the temporal bone.

Treatment:

Procedure: Re-Suspension of the temporal muscle after a craniotomy.

Control

Active Comparator group

Description:

Patients included into this arm will receive a traditional pterional approach for their craniotomy. The temporal muscle will be detached in its entirety.

Treatment:

Procedure: Traditional re-suspension of the temporal muscle