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.
Interventional
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Post-operative mobility of the jaw (e.g. lateral excursion and protrusion)
Data regarding baseline and post-operative range-of-motion of the mouth will be collected before and after surgery.
6 weeks and 1 year post-operatively
Yes
United States: Institutional Review Board
100387
NCT01879280
May 2010
May 2012
Name | Location |
---|---|
Vanderbilt Univesity Medical Center | Nashville, Tennessee 37232 |