Temporal WastingTMSNCT03324516
The Effect of Temporal Muscle Suspension of Temporal Hollowing
A study testing Re-Suspension of the temporal muscle after a craniotomy. and Traditional re-suspension of the temporal muscle in people with Temporal Wasting, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Temporal Wasting
- What is being tested?
- Re-Suspension of the temporal muscle after a craniotomy. and Traditional re-suspension of the temporal muscle
- 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
- 1 Jul 2020to 1 Jan 2021
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- This study will include all patients over the age of 18 years who qualify for a pterional approach for their neurosurgical pathology.
Who cannot join
- Excluded patients will be protected populations, such as inmates or children. Patients will not be excluded on the basis of pregnancy.
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Outpatient CENTER
Baltimore, Maryland, 21231
About this study
Official title: The Effect of Temporal Muscle Suspension of Temporal Hollowing: A Prospective Randomized Clinical Trial
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.
Read the 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:
- Resuspension of the temporalis muscle to the cuff of muscle left on the temporal crest or
- 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).
- Conditions
- Temporal Wasting
- Being tested
- Re-Suspension of the temporal muscle after a craniotomy., Traditional re-suspension of the temporal muscle
- Keywords
- pterional incision, Temporal hollowing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Re-Suspension of the temporal muscle after a craniotomy.Procedure or surgery
The temporal muscle cuff will be used to re-suspend the temporal muscle after a traditional craniotomy.
Traditional re-suspension of the temporal muscleProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Re-Suspension of the temporal muscle after a craniotomy. |
| 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. Receives: Procedure: Traditional re-suspension of the temporal muscle |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (1)
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2017
- Study start1 Jul 2020 (estimated)
- Primary completion1 Jan 2021 (estimated)
- Study completion1 Jan 2021 (estimated)
Why it stopped: Due to limited support staff and time, study was unable to get started
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Temporal WastingStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chad Gordon, DO, Principal investigator, Johns Hopkins Department of Plastics and Reconstructive Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03324516
- Sponsor's protocol ID
- IRB00120812
- Acronym
- TMS
- Status last verified
- Jul 2020
- First submitted
- 19 Oct 2017
- Last updated
- 23 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 8607091Figueiredo 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.
PubMed 18091240
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Temporal Muscle Suspension of Temporal Hollowing: A Prospective Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03324516
- Acronym / sponsor ID
- TMS / IRB00120812
- Conditions
- Temporal Wasting
- Keywords
- pterional incision, Temporal hollowing
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to limited support staff and time, study was unable to get started
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 1 Jul 2020 (estimated)
- Primary completion
- 1 Jan 2021 (estimated)
- Study completion
- 1 Jan 2021 (estimated)
- First posted
- 27 Oct 2017 (actual)
- 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 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:
- Resuspension of the temporalis muscle to the cuff of muscle left on the temporal crest or
- 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Procedure: Re-Suspension of the temporal muscle after a craniotomy.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. |
| Control | Active comparator | Procedure: Traditional re-suspension of the temporal musclePatients included into this arm will receive a traditional pterional approach for their craniotomy. The temporal muscle will be detached in its entirety. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- This study will include all patients over the age of 18 years who qualify for a pterional approach for their neurosurgical pathology.
Key exclusion criteria (1 listed)
- Excluded patients will be protected populations, such as inmates or children. Patients will not be excluded on the basis of pregnancy.
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 |
|---|---|---|
| Re-Suspension of the temporal muscle after a craniotomy.The temporal muscle cuff will be used to re-suspend the temporal muscle after a traditional craniotomy. | Procedure or surgery | Experimental Group |
| Traditional re-suspension of the temporal muscleThe temporal muscle will be re-suspended to the bone plate that is used to fixate the temporal bone that is removed for the craniotomy. | Procedure or surgery | Control |
Primary outcome
Percent change in temporal hallowing
Time frame: 12 months
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.
1 secondary outcome
Patient satisfaction for aesthetic results
Time frame: 12 months
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 23 Jul 2020.
- Background: PubMed 8607091Badie 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.
- Background: PubMed 18091240Figueiredo 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.
- Individual participant dataSharing planned: Undecided
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.
Chad Gordon, DO principal investigator
Johns Hopkins Department of Plastics and Reconstructive Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Re-Suspension of the temporal muscle after a craniotomy. and Traditional re-suspension of the temporal muscle in people with Temporal Wasting, run by Johns Hopkins 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 1 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 23 Jul 2020. 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?
Percent change in temporal hallowing (time frame: 12 months). 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 NCT03324516, which also lists 2 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 23 Jul 2020.