Skull DefectNCT05416684
Prospective Observational Study on Comprehensive Effects of PEEK Cranioplasty and Titanium Cranioplasty After DC（RECEPT-DC）
An observational study of Skull Defect, run by RenJi Hospital at 1 site in China.
Trial summary
The objective of this trial is to scientifically evaluate the efficacy of PEEK cranioplasty and titanium cranioplasty. The primary objective is to compare the rate of implant failure (defined as infection, implant exposure and other causes requiring removal of the implanted material) at any time within 12 months after… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Skull Defect
- How many people
- 358 participants
- Where
- 1 siteChina
- Study dates
- 7 Nov 2024to 30 Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with skull defect
Who may be able to join
- Skull defect with a diameter greater than 3cm
- No intracranial hemorrhage, intracranial hypertension or hydrocephalus (or treated) occurred more than 1 month after the previous operation
- Cranioplasty is feasible according to doctor's evaluation
- Patients must agree to participate in this clinical trial and the informed consent is signed by patients themselves or next of kin on behalf of the patient.
Who cannot join
- Manifestations of intracranial hypertension or untreated hydrocephalus
- Poor healing of skin wound
- Intracerebral infection or intracerebral hematoma is not cured
- Patients with operational contradictions, for example, poor general condition
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, 200127
Zhiyi Zhou, 15921055766, zzyhenry@sina.com
About this study
Official title: A Real World Prospective Observational Study on Evaluation the Comprehensive Effects of Polyetheretherketone Cranioplasty and Titanium Cranioplasty After Decompressive Craniectomy
The objective of this trial is to scientifically evaluate the efficacy of PEEK cranioplasty and titanium cranioplasty. The primary objective is to compare the rate of implant failure (defined as infection, implant exposure and other causes requiring removal of the implanted material) at any time within 12 months after cranioplasty. The secondary objective is to compare the complication rates and neurological function recover following cranioplasty. Complication events after cranioplasty are investigated within 6 months after surgery and neurological function is evaluated at 3, 6 and 12 months after cranioplasty.
- Conditions
- Skull Defect
- Keywords
- Skull Defect, Epilepsy, Infections
- Medical subject headings
- Epilepsy, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| PEEK Group | Not described | |
| Titanium Mesh Group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant Failure
implant failure (defined as infection, implant exposure and other causes requiring removal of the implanted material) at any time within 12 months after cranioplasty.
Measured: Within 12 months
Secondary outcomes (7)
Length of stay in hospital
The duration of hospitalization after operation.
Measured: Within 2 months post-operation
Detailed Economic Evaluation
Total medical expense related to treatment of cranioplasty, including the costs of operations and hospitalization within 6 months post-injury.
Measured: Within 6 months post-operation
Complications Rates
including seizure, hematoma, hydrocephalus, etc.
Measured: 3, 6, and 12 months
Glasgow coma scale (GCS)
The Glasgow coma scale (GCS) is used to assess and calculate the patient's level of consciousness.
Measured: 3, 6, and 12 months
Glasgow outcome scale (GOS)
Measured: 3, 6, and 12 months
Mini-Mental State Examination score (MMSE)
Measured: 3, 6, and 12 months
Appearance Satisfaction
Questionnaire was used to investigate patients' satisfaction with the appearance of cranioplasty.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2022
- Study start7 Nov 2024 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skull DefectStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 358 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Junfeng Feng, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05416684
- Sponsor's protocol ID
- IIT-2021-0111
- Status last verified
- Nov 2024
- First submitted
- 28 May 2022
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real World Prospective Observational Study on Evaluation the Comprehensive Effects of Polyetheretherketone Cranioplasty and Titanium Cranioplasty After Decompressive Craniectomy
- ClinicalTrials.gov ID
- NCT05416684
- Acronym / sponsor ID
- IIT-2021-0111
- Conditions
- Skull Defect
- Keywords
- Skull Defect, Epilepsy, Infections
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 358 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 7 Nov 2024 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 13 Jun 2022 (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 objective of this trial is to scientifically evaluate the efficacy of PEEK cranioplasty and titanium cranioplasty. The primary objective is to compare the rate of implant failure (defined as infection, implant exposure and other causes requiring removal of the implanted material) at any time within 12 months after cranioplasty. The secondary objective is to compare the complication rates and neurological function recover following cranioplasty. Complication events after cranioplasty are investigated within 6 months after surgery and neurological function is evaluated at 3, 6 and 12 months after cranioplasty.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PEEK Group | – | – |
| Titanium Mesh Group | – | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with skull defect
Key inclusion criteria (4 listed)
- Skull defect with a diameter greater than 3cm
- No intracranial hemorrhage, intracranial hypertension or hydrocephalus (or treated) occurred more than 1 month after the previous operation
- Cranioplasty is feasible according to doctor's evaluation
- Patients must agree to participate in this clinical trial and the informed consent is signed by patients themselves or next of kin on behalf of the patient.
Key exclusion criteria (4 listed)
- Manifestations of intracranial hypertension or untreated hydrocephalus
- Poor healing of skin wound
- Intracerebral infection or intracerebral hematoma is not cured
- Patients with operational contradictions, for example, poor general condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Implant Failure
Time frame: Within 12 months
implant failure (defined as infection, implant exposure and other causes requiring removal of the implanted material) at any time within 12 months after cranioplasty.
7 secondary outcomes
Length of stay in hospital
Time frame: Within 2 months post-operation
Detailed Economic Evaluation
Time frame: Within 6 months post-operation
Complications Rates
Time frame: 3, 6, and 12 months
Glasgow coma scale (GCS)
Time frame: 3, 6, and 12 months
Glasgow outcome scale (GOS)
Time frame: 3, 6, and 12 months
Mini-Mental State Examination score (MMSE)
Time frame: 3, 6, and 12 months
Appearance Satisfaction
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
Related trials for Skull Defect
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Active, not recruiting
3D Printed PEEK Implants for Cranioplasty
Skull Defect
Not yet recruiting
Study on the Effect of Ultra-early Autologous Cranioplasty on Neurological Function Recovery
Cranial Defect
Not yet recruiting
Assessment of Accuracy and Aesthetics Following Automated Mandibular Defect Reconstruction Using AI
Mandibular Tumor
Active, not recruitingObservational study
Network Of Clinical Research Studies On Craniosynostosis, Skull Malformations With Premature Fusion Of Skull Bones
Craniosynostosis
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Skull Defect, run by RenJi Hospital at 1 site in China.
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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 12 Nov 2024. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhiyi Zhou (15921055766, zzyhenry@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implant Failure (time frame: Within 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Nov 2024.