The Effect of Temporal Muscle Suspension of Temporal Hollowing (TMS)
Primary Purpose
Temporal Wasting
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Re-Suspension of the temporal muscle after a craniotomy.
Traditional re-suspension of the temporal muscle
Sponsored by
About this trial
This is an interventional treatment trial for Temporal Wasting focused on measuring pterional incision, Temporal hollowing
Eligibility 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.
Sites / Locations
- Johns Hopkins Outpatient CENTER
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental Group
Control
Arm 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.
Patients included into this arm will receive a traditional pterional approach for their craniotomy. The temporal muscle will be detached in its entirety.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT03324516
First Posted
October 19, 2017
Last Updated
July 21, 2020
Sponsor
Johns Hopkins University
1. Study Identification
Unique Protocol Identification Number
NCT03324516
Brief Title
The Effect of Temporal Muscle Suspension of Temporal Hollowing
Acronym
TMS
Official Title
The Effect of Temporal Muscle Suspension of Temporal Hollowing: A Prospective Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Due to limited support staff and time, study was unable to get started
Study Start Date
July 1, 2020 (Anticipated)
Primary Completion Date
January 1, 2021 (Anticipated)
Study Completion Date
January 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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:
Resuspension of the temporalis muscle to the cuff of muscle left on the temporal crest or
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temporal Wasting
Keywords
pterional incision, Temporal hollowing
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
Patients will be given assigned a research limb the morning of the surgery
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental Group
Arm Type
Experimental
Arm 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.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Patients included into this arm will receive a traditional pterional approach for their craniotomy. The temporal muscle will be detached in its entirety.
Intervention Type
Procedure
Intervention Name(s)
Re-Suspension of the temporal muscle after a craniotomy.
Intervention Description
The temporal muscle cuff will be used to re-suspend the temporal muscle after a traditional craniotomy.
Intervention Type
Procedure
Intervention Name(s)
Traditional re-suspension of the temporal muscle
Intervention Description
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 Measure Information:
Title
Percent change in temporal hallowing
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Patient satisfaction for aesthetic results
Description
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.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chad Gordon, DO
Organizational Affiliation
Johns Hopkins Department of Plastics and Reconstructive Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Outpatient CENTER
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
8607091
Citation
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.
Results Reference
background
PubMed Identifier
18091240
Citation
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.
Results Reference
background
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The Effect of Temporal Muscle Suspension of Temporal Hollowing
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