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The Effect of Temporal Muscle Suspension of Temporal Hollowing

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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03324516
Acronym
TMS
Enrollment
0
Registered
2017-10-27
Start date
2020-07-01
Completion date
2021-01-01
Last updated
2020-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Temporal Wasting

Keywords

pterional incision, Temporal hollowing

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).

Interventions

PROCEDURERe-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.

PROCEDURETraditional 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.

Sponsors

Johns Hopkins University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Masking description

Patients will be given assigned a research limb the morning of the surgery

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Percent change in temporal hallowing12 monthsThe 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

MeasureTime frameDescription
Patient satisfaction for aesthetic results12 monthsPatients 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026