The Effect of Temporal Muscle Suspension of Temporal Hollowing

Not Applicable

Withdrawn

• Conditions: Temporal Wasting
• Interventions: Procedure: Re-Suspension of the temporal muscle after a craniotomy.; Procedure: Traditional re-suspension of the temporal muscle

• Registration Number: NCT03324516
• Lead Sponsor: Johns Hopkins University

Brief Summary

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.

Detailed 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).

Study Timeline

• Study First Submitted: 2017-10-19
• Study First Submitted QC: 2017-10-24
• Study First Posted: 2017-10-27
• Status Verified: 2020-07
• Study Start: 2020-07-01
• Last Update Submitted: 2020-07-21
• Last Update Posted: 2020-07-23
• Primary Completion: 2021-01-01
• Study Completion: 2021-01-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Group	Re-Suspension of the temporal muscle after a craniotomy.	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.
Control	Traditional re-suspension of the temporal muscle	Patients included into this arm will receive a traditional pterional approach for their craniotomy. The temporal muscle will be detached in its entirety.

Primary Outcome Measures

Name	Time	Method
Percent change in temporal hallowing	12 months	The primary end point and outcome variable will the CT quantitative evaluation of temporal hollowing. Percent change and volume analysis as compared to the non operated temporal region in a two dimensional and three dimensional view in a CT Scan of the head and face will be the primary outcome variable.

Secondary Outcome Measures

Name	Time	Method
Patient satisfaction for aesthetic results	12 months	Patients will be asked to rate their satisfaction of their aesthetic result on a scale from 1 to 10 with 1 being No satisfaction and 10 being complete satisfaction.

Trial Locations

Locations (1)

Johns Hopkins Outpatient CENTER; 🇺🇸 Baltimore, Maryland, United States