comparison of piezosurgery and conventional instruments in cranioplasty

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

DRKS

Registry ID

DRKS00010553

Enrollment

Registered

2016-06-08

Start date

2014-07-24

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

Q75.0

Interventions

Group 1: osteotomy with standard instruments (rotary instruments [Hilan] and microsaw Group 2: osteotomy with piezosurgery device

Eligibility

Sex/Gender

All

Age

3 Months to 48 Months

Inclusion criteria

Inclusion criteria: patients with craniosynostosis (trigonocephalus, plagiocephalus, brachycephalus, syndromale craniosynostosis) and indication for frontooribital Advancement

Exclusion criteria

Exclusion criteria: congenital heart defect, bleeding diathesis, systemic bone diseases

Design outcomes

Primary

Measure	Time frame
surgery time, complete blood count and amount of blood transfusion, soft tissue tears, edema, pain and bone healing are documented. The data evaluation is finished with the last parameters 4 - 6 month after cranioplasty (at the time of plate removal): the appraisal of ossification	—

Secondary

Measure	Time frame
Postoperatively, the volume of blood losses through surgical hemoglobin measured three times during the first 5 days after surgery and a pain score is evaluated	—

Countries

Germany

Contacts

Public ContactMartina Messing-Jünger

Abteilung für KinderneurochirurgieAsklepios Kinderklinik

m.messing@asklepios.com02241-249246

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026