Clinical trial NCT03324516: The Effect of Temporal Muscle Suspension of Temporal Hollowing
Official title: The Effect of Temporal Muscle Suspension of Temporal Hollowing: A Prospective Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Temporal Wasting
Keywords: pterional incision
Temporal hollowing
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2017-10-27
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Percent change in temporal hallowing
timeFrame: 12 months
Secondary outcomes:
measure: Patient satisfaction for aesthetic results
timeFrame: 12 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Outpatient CENTER
state: Maryland
Study officials:
affiliation: Johns Hopkins Department of Plastics and Reconstructive Surgery
name: Chad Gordon, DO
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.