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

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ClinicalTrials.gov Identifier: NCT03324516
Recruitment Status : Withdrawn (Due to limited support staff and time, study was unable to get started)
First Posted : October 27, 2017
Last Update Posted : July 23, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Temporal Wasting Procedure: Re-Suspension of the temporal muscle after a craniotomy. Procedure: Traditional re-suspension of the temporal muscle Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: Patients will be given assigned a research limb the morning of the surgery
Primary Purpose: Treatment
Official Title: The Effect of Temporal Muscle Suspension of Temporal Hollowing: A Prospective Randomized Clinical Trial
Estimated Study Start Date : July 1, 2020
Estimated Primary Completion Date : January 1, 2021
Estimated Study Completion Date : January 1, 2021

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.




Primary Outcome Measures :
  1. Percent change in temporal hallowing [ Time Frame: 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 :
  1. Patient satisfaction for aesthetic results [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03324516


Locations
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United States, Maryland
Johns Hopkins Outpatient CENTER
Baltimore, Maryland, United States, 21231
Sponsors and Collaborators
Johns Hopkins University
Investigators
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Principal Investigator: Chad Gordon, DO Johns Hopkins Department of Plastics and Reconstructive Surgery
  Study Documents (Full-Text)

Documents provided by Johns Hopkins University:
Informed Consent Form  [PDF] October 24, 2017

Publications:
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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03324516    
Other Study ID Numbers: IRB00120812
First Posted: October 27, 2017    Key Record Dates
Last Update Posted: July 23, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Johns Hopkins University:
pterional incision
Temporal hollowing
Additional relevant MeSH terms:
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Wasting Syndrome
Cachexia
Emaciation
Weight Loss
Body Weight Changes
Body Weight
Metabolic Diseases
Nutrition Disorders