Effects of Early Skull Repair With Titanium Mesh on Cerebral Blood Flow and Neurological Recovery

February 7, 2018 updated by: Yase Zhuang, Taihe Hospital

Effects of Early Skull Repair With Titanium Mesh on Cerebral Blood Flow and Neurological Recovery: a Randomized Controlled Clinical Trial Based on CT Perfusion Evaluation

To evaluate the feasibility of CT perfusion technique to monitor the changes of blood perfusion in the brain tissue before and after skull repair using titanium mesh. To determine the best timing for skull repair using the three-dimensional titanium mesh; to compare the effects of early (1-3 months after decompression) and late-stage (6-12 months after decompression) skull repair on neurologic rehabilitation.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

A skull defect is inevitable in patients with traumatic brain injury undergoing decompression treatment, which results in a loss of physiological and functional integrity of the brain that makes atmospheric pressure directly act on the brain tissue to induce environmental disorders in the brain. Moreover, with the changes in the body position, the contents of the brain often move in an unstable position, and with the extension of time, there may be compensatory ventricular enlargement and brain atrophy, eventually causing neurological dysfunction and cognitive disorders. Therefore, it is imperative to repair the skull defect.

There are many repair materials for skull defects, including autogenous bone, allogeneic bone, nonmetallic materials (plexiglass, bone cement, silicone rubber, etc.) and titanium mesh. The performance of different materials have their own advantages and disadvantages, and titanium alloy is an ideal repair material and has been widely used in clinical practice because of good biocompatibility and strength, no aging, low density, non-iron atoms, ability to be not magnetized in magnetic fields, and no influence on CT, MRI, EEG and X-ray examination.

The timing for repair of skull defect after traumatic brain injury is still controversial. Some scholars believe that if there is no hydrocephalus and intracranial infection after decompression with removal of bone flap, skull repair should be proceeded as soon as possible to isolate the scalp from the dura mater and recover the normal intracranial pressure by easing the negative effects of the scalp, such as cerebrovascular traction, compression and distortions. Most importantly, early skull repair is able to reduce a variety of secondary neurological deficits due to skull defects, increase brain surface blood flow, and thus reduce epileptic attack. Of course, some scholars recommend late-stage skull repair, and they believe hematoma absorption after decompressive surgery is a long process, and in some patients, hematoma will be completely absorbed in about 3 months or even longer, which may result in secondary brain edema. Moreover, surgical trauma exerts negative effect on the brain tissue recovery, which is not conducive to neurologic rehabilitation.

As there is no unified conclusion on the timing for the repair of skull defects, investigators conducted a multi-sample, double-blind, randomized, clinical trial, to collect craniocerebral injury patients undergoing decompression with removal of bone graft who were randomized into two groups to receive early skull repair in test group and late-stage skull repair in control group. CT perfusion technology was used to monitor the blood perfusion in the brain before and after skull repair and to compare the changes of blood perfusion in the brain tissue and neurological recovery in patients undergoing early or late-stage skull repair.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
86

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Eighty-six patients with craniocerebral injury who had undergone decompression with removal of bone flap from January 2013 to January 2016 were recruited and subjected to skull repair using titanium mesh. All the patients were randomized into two groups: test group (n = 40) with early skull repair within 1-3 months after decompression and control group (n = 46) with late-stage skull repair within 6-12 months after decompression.

Description

Inclusion Criteria:

  • Patients underwent decompression via removal of bone flap in the unilateral frontal temporal lobe due to craniocerebral injury and developed no postoperative infection.
  • Patients agreed to receive skull repair using titanium mesh.
  • Patients and their families agreed to receive CT perfusion examination.
  • Patients and their families fully understood the study protocol and agreed to participate in the trial, and then singed the informed consent before the trial.

Exclusion Criteria:

  • Hypertension and diabetes out of control, severe heart disease, brain tumors, brain abscess, and cerebral infarction
  • Diseases that have interfered with localized perfusion data, such as intracranial aneurysms, arteriovenous malformations
  • Combined with depressed skull fractures and skull base fractures
  • Hydrocephalus

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
test group
Patients with craniocerebral injury were randomized into test group (n = 40) with early skull repair using titanium mesh within 1-3 months after decompression.
Device: early skull repair
Patients with craniocerebral injury were randomized into test group (n = 40) with early skull repair using titanium mesh within 1-3 months after decompression.
Other Names:
  • test group
control group
Patients with craniocerebral injury were randomized into control group (n = 46) with late-stage skull repair using titanium mesh within 6-12 months after decompression.
Device: late-stage skull repair
Patients with craniocerebral injury were randomized into control group (n = 46) with late-stage skull repair using titanium mesh within 6-12 months after decompression.
Other Names:
  • control group

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
blood perfusion in the brain tissue
Time Frame: changes from day 3 before surgery to day 10 after surgery
To monitor the changes of blood perfusion in the brain tissue based on CT perfusion technology after skull repair with titanium mesh. 50 mL of iopromide was injected at a rate of 5 mL/s into the median cubital vein of the patients, and 3 seconds later, 256-slice spiral CT (Philips) was used for continuous scan for 50 seconds, followed by image processing using a Philips-specific workstation.
changes from day 3 before surgery to day 10 after surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Barthel index
Time Frame: at day 30 after surgery
To measure performance in activities of daily living. The full scores of Barthel index is 100. A higher score is associated with a greater likelihood of being able to live: > 60, mild disability with the ability to basically take care of oneself; 40-60, moderate disability with the need for help in activities of daily living; 20-40, severe disability with the need for great help in activities of daily living; < 20, complete disability with the inability to care for oneself.
at day 30 after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Taihe Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2013

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2017

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 12, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 16, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 19, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 9, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 7, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TaiheH_002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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