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Safety and efficacy of three-dimensional shaping titanium plate in subtemporal repair of skull defects

Safety and efficacy of three-dimensional shaping titanium plate in subtemporal repair of skull defects

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IOC-17012947
Enrollment
Unknown
Registered
2017-10-11
Start date
2017-11-01
Completion date
Unknown
Last updated
2017-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

skull defects

Interventions

1:Titanium mesh

Sponsors

The First People's Hospital of Wujiang District
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Unilateral frontotemporal skull defects; 2. Skull defect diameter > 3 cm; 3. Skull repair 3 months after decompressive craniectomy; 4. Consciousness, Glasgow Coma Scale scores>13; 5. Stable heart, lung, liver and kidney indicators; 6. Aged from 20 to 70 years old.

Exclusion criteria

Exclusion criteria: 1. Skin infection at the surgical area; 2. No obvious edema, no obvious shift in the midline structure, or no obvious ventricular dilatation revealed by skull CT scan; 3. Intracranial hypertension after decompressive craniectomy; 4. Thin scalp at the defect site; 5. Asymmetrical bilateral skulls before first craniotomy; 6. Severe heart, liver, and kidney dysfunction; 7. Poor general conditions; 8. Severe neurological deficits; 9. Possibly sensitive to titanium mesh materials; 10. Participation in other material clinical trials within 3 months; 11. Pregnancy, suspected pregnancy and breastfeeding women.

Design outcomes

Secondary

MeasureTime frame
Glasgow Outcome Scale;Karnofsky Performance Scale;National Institute of Health Stroke Scale;Skull CT scans;Surgical indicators;

Primary

MeasureTime frame
incidence of complications;

Countries

China

Contacts

Public ContactWei Qian

The First People's Hospital of Wujiang District

Qianwei121@163.com+86 13584409679

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 27, 2026