Pterional CraniotomyNCT01879280
Effect of Craniotomy on Temporalis Function
A study testing Traditional pterional craniotomy and Osteoplastic craniotomy in people with Pterional Craniotomy, run by Vanderbilt University at 1 site in United States.
Trial summary
The scientific objectives of this study are to systematically study the problems that are created by incising the attachment of the temporalis muscle in a randomized group of patients, and to determine whether another approach that does not detach the temporalis muscle results in less post-operative morbidity. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Pterional Craniotomy
- What is being tested?
- Traditional pterional craniotomy and Osteoplastic craniotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to May 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- o The selection of participants is based solely on future plans to undergo a pterional craniotomy for resection of a tumor.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt Univesity Medical Center
Nashville, Tennessee, 37232
About this study
The scientific objectives of this study are to systematically study the problems that are created by incising the attachment of the temporalis muscle in a randomized group of patients, and to determine whether another approach that does not detach the temporalis muscle results in less post-operative morbidity. Cutting through the attachment of the temporalis muscle to the skull is a widely-accepted procedure used to gain access to the skull prior to the drilling used for a pterional craniotomy (one of the most frequent types of surgeries used in neurosurgical practice). Despite the frequent use of this maneuver and the known sequelae of temporalis mobilization (e.g. post-operative myofascial pain, temporalis weakness, and pain with mastication), very little is known about the true incidence of these post-operative symptoms. Furthermore, there is very little objective evidence at the present time to support the claim that the incidence and severity of these post-operative phenomena can be decreased with use of an osteoplastic craniotomy (a procedure where the temporalis is left attached to the bony calvarium). The investigators would like to evaluate whether this slightly more time-consuming and technically demanding approach is less morbid in this respect than the contemporary pterional approach. Special note is made that the osteoplastic approach has been used in standard neurosurgical practice for quite some time.
Read the 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.
- Conditions
- Pterional Craniotomy
- Being tested
- Traditional pterional craniotomy, Osteoplastic craniotomy
- Keywords
- pterional craniotomy, osteoplastic craniotomy, temporalis, minimally-invasive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional pterional craniotomyProcedure or surgery
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.
Osteoplastic craniotomyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| osteoplastic craniotomy | Experimental | 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. Receives: Procedure: Traditional pterional craniotomy; Procedure: Osteoplastic craniotomy |
| traditional pterional craniotomy | Active comparator | traditional pterional craniotomy Receives: Procedure: Traditional pterional craniotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks and 1 year post-operatively
Secondary outcomes (2)
Post-operative pain with chewing
Data regarding baseline and post-operative pain with chewing will be obtained at 6 months and 1 year.
Measured: 6 weeks and 1 year
Post-operative cosmesis of the temporal region
Data regarding baseline and post-operative cosmesis will be obtained and 6 weeks and 1 year post-operatively.
Measured: 6 weeks and 1 year post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2013 (estimated)
- Study startMay 2010
- Primary completionDec 2011
- Study completionMay 2012
Why it stopped: low enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pterional CraniotomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kyle Weaver, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01879280
- Sponsor's protocol ID
- 100387
- Status last verified
- Jun 2013
- First submitted
- 29 Apr 2010
- Last updated
- 17 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 15926727Rocha-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.
PubMed 17764986de 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.
PubMed 9698728
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Craniotomy on Temporalis Function
- ClinicalTrials.gov ID
- NCT01879280
- Acronym / sponsor ID
- 100387
- Conditions
- Pterional Craniotomy
- Keywords
- pterional craniotomy, osteoplastic craniotomy, temporalis, minimally-invasive
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: low enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 17 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The scientific objectives of this study are to systematically study the problems that are created by incising the attachment of the temporalis muscle in a randomized group of patients, and to determine whether another approach that does not detach the temporalis muscle results in less post-operative morbidity. Cutting through the attachment of the temporalis muscle to the skull is a widely-accepted procedure used to gain access to the skull prior to the drilling used for a pterional craniotomy (one of the most frequent types of surgeries used in neurosurgical practice). Despite the frequent use of this maneuver and the known sequelae of temporalis mobilization (e.g. post-operative myofascial pain, temporalis weakness, and pain with mastication), very little is known about the true incidence of these post-operative symptoms. Furthermore, there is very little objective evidence at the present time to support the claim that the incidence and severity of these post-operative phenomena can be decreased with use of an osteoplastic craniotomy (a procedure where the temporalis is left attached to the bony calvarium). The investigators would like to evaluate whether this slightly more time-consuming and technically demanding approach is less morbid in this respect than the contemporary pterional approach. Special note is made that the osteoplastic approach has been used in standard neurosurgical practice for quite some time.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| osteoplastic craniotomy | Experimental | Procedure: Traditional pterional craniotomy, Procedure: Osteoplastic craniotomyHalf 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. |
| traditional pterional craniotomy | Active comparator | Procedure: Traditional pterional craniotomytraditional pterional craniotomy |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- o The selection of participants is based solely on future plans to undergo a pterional craniotomy for resection of a tumor.
Key exclusion criteria (2 listed)
- o Because patient feedback and participation is necessary, cognitively impaired patients are excluded from this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Traditional pterional craniotomyIn 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. | Procedure or surgery | osteoplastic craniotomy, traditional pterional craniotomy |
| Osteoplastic craniotomyIn 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. | Procedure or surgery | osteoplastic craniotomy |
Primary outcome
Post-operative mobility of the jaw (e.g. lateral excursion and protrusion)
Time frame: 6 weeks and 1 year post-operatively
Data regarding baseline and post-operative range-of-motion of the mouth will be collected before and after surgery.
2 secondary outcomes
Post-operative pain with chewing
Time frame: 6 weeks and 1 year
Post-operative cosmesis of the temporal region
Time frame: 6 weeks and 1 year post-operatively
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2013.
- Background: PubMed 15926727Balasingam 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.
- Results publication: PubMed 17764986Rocha-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.
- Results publication: PubMed 9698728de 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.
- paper #3Link provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional pterional craniotomy and Osteoplastic craniotomy in people with Pterional Craniotomy, run by Vanderbilt University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 17 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative mobility of the jaw (e.g. lateral excursion and protrusion) (time frame: 6 weeks and 1 year post-operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01879280, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2013.