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Due to limited support staff and time, study was unable to get started
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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.
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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group | Experimental | 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. |
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| Control | Active Comparator | Patients included into this arm will receive a traditional pterional approach for their craniotomy. The temporal muscle will be detached in its entirety. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Re-Suspension of the temporal muscle after a craniotomy. | Procedure | The temporal muscle cuff will be used to re-suspend the temporal muscle after a traditional craniotomy. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chad Gordon, DO | Johns Hopkins Department of Plastics and Reconstructive Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Outpatient CENTER | Baltimore | Maryland | 21231 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8607091 | Background | 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. | |
| 18091240 | Background | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 24, 2017 | Oct 24, 2017 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 24, 2017 | Oct 24, 2017 | ICF_001.pdf |
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Patients will be given assigned a research limb the morning of the surgery
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| Traditional re-suspension of the temporal muscle | Procedure | 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. |
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