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NCT Number: NCT05416684

Prospective Observational Study on Comprehensive Effects of PEEK Cranioplasty and Titanium Cranioplasty After DC（RECEPT-DC）

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.

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Key information

Conditions

Skull Defect Brain Diseases Central Nervous System Diseases Epilepsy Infections Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, 200127, China

Location status: Recruiting

Location contact

Zhiyi Zhou

CONTACT

[email protected]

15921055766

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Length of stay in hospital

    Time frame: Within 2 months post-operation

    The duration of hospitalization after operation.

  2. Detailed Economic Evaluation

    Time frame: Within 6 months post-operation

    Total medical expense related to treatment of cranioplasty, including the costs of operations and hospitalization within 6 months post-injury.

  3. Complications Rates

    Time frame: 3, 6, and 12 months

    including seizure, hematoma, hydrocephalus, etc.

  4. Glasgow coma scale (GCS)

    Time frame: 3, 6, and 12 months

    The Glasgow coma scale (GCS) is used to assess and calculate the patient's level of consciousness.

  5. Glasgow outcome scale (GOS)

    Time frame: 3, 6, and 12 months

  6. Mini-Mental State Examination score (MMSE)

    Time frame: 3, 6, and 12 months

  7. Appearance Satisfaction

    Time frame: 6 months

    Questionnaire was used to investigate patients' satisfaction with the appearance of cranioplasty.

Study contacts

Contact information is provided by the study sponsor or research team.

Zhiyi Zhou

CONTACT

[email protected]

15921055766

Sponsors and collaborators

Lead sponsor

RenJi Hospital

Other

Registry information

Official study title

A Real World Prospective Observational Study on Evaluation the Comprehensive Effects of Polyetheretherketone Cranioplasty and Titanium Cranioplasty After Decompressive Craniectomy

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jun 13, 2022
Registry last updated
Nov 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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