- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01879280
Effect of Craniotomy on Temporalis Function
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
In contemporary neurosurgery, when performing a pterional craniotomy, neurosurgeons have been taught to cut through and detach the temporalis before drilling the skull to "turn a bone flap". While there are ways to turn a bone flap with the temporalis still attached (i.e., an "osteoplastic craniotomy"), this is thought to be slightly more time-consuming and is used less often in many centers. Additionally, there is a common misconception that osteoplastic craniotomy does not allow an equivalent view, although recent evidence suggests that the surgical exposure in the two approaches is no different. Aside from the extra time involved, we do not feel that leaving the temporalis attached to the bony calvarium disadvantages the patient in any fashion (and-in fact-may result in less post-operative morbidity). We are interested in this project because there is actually very little objective data regarding the morbidity people experience when the temporalis muscle is cut and mobilized prior to drilling the skull. If, in this study, we find that the group randomized to traditional pterional craniotomy experiences significantly more morbidity than the group randomized to osteoplastic craniotomy, this may justify conversion to an osteoplastic craniotomy in many or all instances.
We wish to quantify the morbidity that is associated with the specific methods used to detach the temporalis muscle from the skull. Many variables regarding the way the temporalis is detached will be recorded and assessed in the group randomized to traditional pterional craniotomy. Additionally, many methods will be used to measure post-operative temporalis atrophy and/or dysfunction in the two randomized groups. After post-operative morbidity has been quantified, we plan to compare the traditional pterional group to the osteoplastic group and assess for significance.
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Tennessee
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Nashville, Tennessee, United States, 37232
- Vanderbilt Univesity Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- o The selection of participants is based solely on future plans to undergo a pterional craniotomy for resection of a tumor.
Exclusion Criteria:
o Because patient feedback and participation is necessary, cognitively impaired patients are excluded from this study.
- Also, generalized cachexia, prior history of craniotomy, or any other reason for baseline temporalis asymmetry or poor wound healing is also reason for exclusion from this study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: osteoplastic craniotomy
Half of the study population will be randomized to traditional pterional craniotomy as the method of exposure.
The other half will be randomized to osteoplastic craniotomy as the method of exposure.
All other aspects of medical care will remain the same.
|
In the standard pterional craniotomy group, the attachment of the temporalis will be cut and the temporalis will be mobilized prior to exposure of the underlying bony calvarium.
This maneuver is currently accepted for use by the majority of neurosurgeons nationwide.
In the osteoplastic group, the temporalis will be left attached to the bony calvarium prior to exposure of the tumor.
There are ways to turn a bone flap with the temporalis still attached (i.e., an "osteoplastic craniotomy").
However, this method is thought to be slightly more time-consuming and is used less often in many centers.
Aside from the extra time involved, we do not feel that leaving the temporalis attached to the bony calvarium disadvantages the patient in any fashion and may--in fact--result in less post-operative morbidity.
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Active Comparator: traditional pterional craniotomy
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In the standard pterional craniotomy group, the attachment of the temporalis will be cut and the temporalis will be mobilized prior to exposure of the underlying bony calvarium.
This maneuver is currently accepted for use by the majority of neurosurgeons nationwide.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Post-operative mobility of the jaw (e.g. lateral excursion and protrusion)
Time Frame: 6 weeks and 1 year post-operatively
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Data regarding baseline and post-operative range-of-motion of the mouth will be collected before and after surgery.
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6 weeks and 1 year post-operatively
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Post-operative pain with chewing
Time Frame: 6 weeks and 1 year
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Data regarding baseline and post-operative pain with chewing will be obtained at 6 months and 1 year.
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6 weeks and 1 year
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Post-operative cosmesis of the temporal region
Time Frame: 6 weeks and 1 year post-operatively
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Data regarding baseline and post-operative cosmesis will be obtained and 6 weeks and 1 year post-operatively.
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6 weeks and 1 year post-operatively
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Balasingam V, Noguchi A, McMenomey SO, Delashaw JB Jr. Modified osteoplastic orbitozygomatic craniotomy. Technical note. J Neurosurg. 2005 May;102(5):940-4. doi: 10.3171/jns.2005.102.5.0940.
- Rocha-Filho PA, Fujarra FJ, Gherpelli JL, Rabello GD, de Siqueira JT. The long-term effect of craniotomy on temporalis muscle function. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2007 Nov;104(5):e17-21. doi: 10.1016/j.tripleo.2007.05.029. Epub 2007 Aug 30.
- de Andrade Junior FC, de Andrade FC, de Araujo Filho CM, Carcagnolo Filho J. Dysfunction of the temporalis muscle after pterional craniotomy for intracranial aneurysms. Comparative, prospective and randomized study of one flap versus two flaps dieresis. Arq Neuropsiquiatr. 1998 Jun;56(2):200-5. doi: 10.1590/s0004-282x1998000200006.
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 100387
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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