The Effect of Temporal Muscle Suspension of Temporal Hollowing
NCT ID: NCT03324516
Last Updated: 2020-07-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2020-07-01
2021-01-01
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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.
Control
Patients included into this arm will receive a traditional pterional approach for their craniotomy. The temporal muscle will be detached in its entirety.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
Yes
Sponsors
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Johns Hopkins University
OTHER
Responsible Party
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Principal Investigators
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Chad Gordon, DO
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins Department of Plastics and Reconstructive Surgery
Locations
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Johns Hopkins Outpatient CENTER
Baltimore, Maryland, United States
Countries
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References
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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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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IRB00120812
Identifier Type: -
Identifier Source: org_study_id
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