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CranioplastyNCT06740773

Risk Factors for Complications After Cranioplasty

An observational study of Cranioplasty and Postoperative Complications, run by Qilu Hospital of Shandong University at 3 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Cranial defects often result from brain injuries, hemorrhages, strokes, or brain tumors. These conditions can increase pressure inside the skull, and if left untreated, may lead to dangerous complications like brain herniation. Read more about this study

Who is it for?
Any age
How many people
1,368 participants
Where
3 sitesChina
Study dates
17 Dec 2024to 31 Dec 2025
Phase
Observational
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Patients with cranial defects who underwent their first cranioplasty in the Department of Neurosurgery at Qilu Hospital of Shandong University between January 1, 2015, and January 1, 2025, or at Tangdu Hospital of Air Force Medical University or Daping Hospital of the Army Medical University between January 1, 2015, and July 31, 2023.

Who may be able to join

  • Patients who underwent cranioplasty in the Department of Neurosurgery at Qilu Hospital of Shandong University, Tangdu Hospital of Air Force Medical University, or Daping Hospital, Army Military Medical University between January 1, 2015, and July 31, 2023
  • Diagnosed with cranial defects
  • Possessed complete and accessible electronic medical records
  • Patients had no prior history of cranioplasty

Who cannot join

  • Patients with a prior history of cranioplasty
  • Severe comorbidities (such as serious cardiac, liver, kidney and immune system dysfunction)
  • Congenital cranial defects
  • Severe missing data

Trial locations and contacts

3 sites in 1 country.

China3 sites

  • Department of Neurosurgery, Daping Hospital of Army Medical University

    Chongqing, Chongqing Municipality, 400042

  • Department of Neurosurgery, Qilu Hospital of Shandong University

    Jinan, Shandong, 250012

  • Department of Neurosurgery, Tang-Du Hospital

    Xi'an, Shaanxi, 710038

Other trials in China

About this study

Official title: A Retrospective Study to Identify Risk Factors for Complications After Cranioplasty

Cranial defects often result from brain injuries, hemorrhages, strokes, or brain tumors. These conditions can increase pressure inside the skull, and if left untreated, may lead to dangerous complications like brain herniation. To manage this, a common procedure called decompressive craniectomy is performed to reduce intracranial pressure. While this surgery often stabilizes the patient's condition, it leaves a cranial defect that exposes the brain to external risks, including pressure fluctuations and potential damage. In severe cases, patients with larger defects may develop complications such as sinking skin flap syndrome.

Cranial reconstruction, also known as cranioplasty, is an important procedure to restore the skull's structure and protect the brain. This surgery can improve brain function, stabilize intracranial pressure, and enhance the patient's appearance. While cranioplasty is a standard neurosurgical procedure, it has a relatively high risk of complications compared to other brain surgeries. Common complications include infections, bleeding, hydrocephalus, and seizures. In severe cases, complications may lead to the failure of the reconstruction.

Understanding the factors that contribute to complications after cranioplasty is crucial for neurosurgeons to improve outcomes and reduce risks. This study aims to identify these factors and develop predictive models for postoperative complications of cranioplasty.

Read the detailed description

Cranial defects, often caused by conditions such as traumatic brain injuries, strokes, or brain tumors, present a significant clinical challenge. Decompressive craniectomy, frequently performed to manage increased intracranial pressure, leaves patients with cranial defects that require subsequent cranioplasty. Cranioplasty, while being a common neurosurgical procedure, has a higher complication rate compared to other cranial surgeries, warranting a deeper investigation into its risk factors.

In addition to identifying risk factors, this study aims to develop and validate predictive models for postoperative complications. Advanced statistical techniques, such as machine learning algorithms, will be used to assess the contribution of individual variables to complication risk.

By leveraging a large multi-center dataset, the study seeks to provide actionable insights into the prevention of postoperative complications. The results are expected to inform clinical decision-making, enhance patient outcomes, and improve the quality of perioperative care in neurosurgical practice.

Keywords
Cranioplasty, Postoperative Complications, Risk factors, Retrospective Study, predictive model
Medical subject headings
Postoperative Complications

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06740773
Study groupRoleWhat they receive
Derivation CohortIdentification of risk factors, development and internal validation of predictive models
External Validation CohortExternal validation of the predictive models

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Risk factors for postoperative complications of cranioplasty

    The primary outcome is to identify factors associated with postoperative complications of cranioplasty. The analysis will focus on patient demographics, comorbidities, surgical details, and other clinical variables extracted from medical records

    Measured: From the date of cranioplasty to the date of hospital discharge, with complications assessed throughout the hospitalization period, up to 60 days.

Secondary outcomes (1)

  1. Establishment predictive models for postoperative complications of cranioplasty

    The secondary outcome is to develop and validate predictive models for postoperative complications of cranioplasty based on identified risk factors.

    Measured: From the date of cranioplasty to the date of hospital discharge, with complications assessed throughout the hospitalization period, up to 60 days.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Dec 2024
  2. Study start17 Dec 2024
  3. Primary completion31 Aug 2025
  4. Study completion31 Dec 2025

Resources

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
Cohort
Time perspective
Retrospective
Enrolment
1,368 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06740773
Sponsor's protocol ID
KYLL-202407-041
Status last verified
Sep 2026
First submitted
11 Dec 2024
Last updated
4 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All collected IPD

Publications

  • Bader ER, Kobets AJ, Ammar A, Goodrich JT. Factors predicting complications following cranioplasty. J Craniomaxillofac Surg. 2022 Feb;50(2):134-139. doi: 10.1016/j.jcms.2021.08.001. Epub 2021 Aug 25.

    PubMed 34580005

  • Chaturvedi J, Botta R, Prabhuraj AR, Shukla D, Bhat DI, Devi BI. Complications of cranioplasty after decompressive craniectomy for traumatic brain injury. Br J Neurosurg. 2016;30(2):264-8. doi: 10.3109/02688697.2015.1054356. Epub 2015 Jun 17.

    PubMed 26083136

  • Zanaty M, Chalouhi N, Starke RM, Clark SW, Bovenzi CD, Saigh M, Schwartz E, Kunkel ES, Efthimiadis-Budike AS, Jabbour P, Dalyai R, Rosenwasser RH, Tjoumakaris SI. Complications following cranioplasty: incidence and predictors in 348 cases. J Neurosurg. 2015 Jul;123(1):182-8. doi: 10.3171/2014.9.JNS14405. Epub 2015 Mar 13.

    PubMed 25768830

  • Belzberg M, Mitchell KA, Ben-Shalom N, Asemota AO, Wolff AY, Santiago GF, Shay T, Huang J, Manson PN, Brem H, Gordon CR. Cranioplasty Outcomes From 500 Consecutive Neuroplastic Surgery Patients. J Craniofac Surg. 2022 Sep 1;33(6):1648-1654. doi: 10.1097/SCS.0000000000008546. Epub 2022 Mar 4.

    PubMed 35245275

  • Malcolm JG, Rindler RS, Chu JK, Grossberg JA, Pradilla G, Ahmad FU. Complications following cranioplasty and relationship to timing: A systematic review and meta-analysis. J Clin Neurosci. 2016 Nov;33:39-51. doi: 10.1016/j.jocn.2016.04.017. Epub 2016 Aug 4.

    PubMed 27499122

  • Singh S, Singh R, Jain K, Walia B. Cranioplasty following decompressive craniectomy - Analysis of complication rates and neurological outcomes: A single center study. Surg Neurol Int. 2019 Jul 19;10:142. doi: 10.25259/SNI_29_2019. eCollection 2019.

    PubMed 31528477

  • Honeybul S, Ho KM. Long-term complications of decompressive craniectomy for head injury. J Neurotrauma. 2011 Jun;28(6):929-35. doi: 10.1089/neu.2010.1612. Epub 2011 Jun 1.

    PubMed 21091342

  • Henry J, Amoo M, Murphy A, O'Brien DP. Complications of cranioplasty following decompressive craniectomy for traumatic brain injury: systematic review and meta-analysis. Acta Neurochir (Wien). 2021 May;163(5):1423-1435. doi: 10.1007/s00701-021-04809-z. Epub 2021 Mar 23.

    PubMed 33759012

Questions about this trial

What is this clinical trial studying?

An observational study of Cranioplasty and Postoperative Complications, run by Qilu Hospital of Shandong University at 3 sites 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: finished, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Risk factors for postoperative complications of cranioplasty (time frame: From the date of cranioplasty to the date of hospital discharge, with complications assessed throughout the hospitalization period, up to 60 days.). 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 NCT06740773, which also lists 8 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 4 Nov 2026; AzTrials last refreshed its copy on 6 Nov 2026.

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