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

The Effect of Temporal Muscle Suspension of Temporal Hollowing: A Prospective Randomized Clinical Trial

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.

Study Overview

• Status: Withdrawn
• Conditions: Temporal Wasting
• Intervention / Treatment: Procedure: Re-Suspension of the temporal muscle after a craniotomy.; Procedure: Traditional re-suspension of the temporal muscle

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21231
      • Johns Hopkins Outpatient Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group; 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.	Procedure: Re-Suspension of the temporal muscle after a craniotomy.; The temporal muscle cuff will be used to re-suspend the temporal muscle after a traditional craniotomy.
Active Comparator: Control; Patients included into this arm will receive a traditional pterional approach for their craniotomy. The temporal muscle will be detached in its entirety.	Procedure: Traditional re-suspension of the temporal muscle; The temporal muscle will be re-suspended to the bone plate that is used to fixate the temporal bone that is removed for the craniotomy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent change in temporal hallowing	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.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction for aesthetic results	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.	12 months

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Investigators: Principal Investigator: Chad Gordon, DO, Johns Hopkins Department of Plastics and Reconstructive Surgery

Publications and helpful links

General Publications

• Figueiredo EG, Deshmukh P, Nakaji P, Crusius MU, Crawford N, Spetzler RF, Preul MC. The minipterional craniotomy: technical description and anatomic assessment. Neurosurgery. 2007 Nov;61(5 Suppl 2):256-64; discussion 264-5. doi: 10.1227/01.neu.0000303978.11752.45.
• Badie B. Cosmetic reconstruction of temporal defect following pterional [corrected] craniotomy. Surg Neurol. 1996 Apr;45(4):383-4. doi: 10.1016/0090-3019(95)00452-1.

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2020
• Primary Completion (Anticipated): January 1, 2021
• Study Completion (Anticipated): January 1, 2021

Study Registration Dates

• First Submitted: October 19, 2017
• First Submitted That Met QC Criteria: October 24, 2017
• First Posted (Actual): October 27, 2017

Study Record Updates

• Last Update Posted (Actual): July 23, 2020
• Last Update Submitted That Met QC Criteria: July 21, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Temporal hollowing; pterional incision
• Additional Relevant MeSH Terms: Metabolic Diseases; Nutrition Disorders; Body Weight; Body Weight Changes; Emaciation; Weight Loss; Wasting Syndrome; Cachexia
• Other Study ID Numbers: IRB00120812

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No