Clinical Accuracy of Patient-specific Implants in Genioplasty
The Application and Clinical Accuracy of Patient-specific Implants in Genioplasty
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
Chin plays an important role in the lower facial harmony and balance. With the advances in computer-aided surgical simulation (CASS) technology, surgeons are now able to simulate surgical procedures in the computer to achieve the best possible surgical plan. However, CAD/CAM surgical templates do not maximize the potential of CASS technique. Patient specific implants (PSI) has rapidly developed in cranio-maxillofacial surgery in the past few years. However, few studies have introduced PSI technique in osseous genioplasty. The purpose of this study is to assess the accuracy and clinical validation of patient specific implants (PSI) technique in genioplasty for positioning and fixation of the chin segment.
Anticipated 30 patients with chin deformities are enrolled. Virtual planning is performed with the computer-aided surgical simulation method. The 3D printing titanium cutting guide and patient specific plate is involved in this PSI method. The cutting guide is designed to guide the osteotomy and screw holes drilling for the following patient specific plate. And the patient specific plate is used to simultaneously complete the reposition and fixation of the chin. The outcome is evaluated by comparing the plan with actual outcomes.
Studietype
Registrering (Forventet)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Shanghai, Kina
- Rekruttering
- Ninth People's Hospital, Shanghai Jiaotong University School of Medicine
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Ta kontakt med:
- Biao Li, Master
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- patients who were scheduled to undergo genioplasty;
- patients who were scheduled to undergo CT scan as a part of their diagnosis and treatment;
- patients who agreed to participate in this study
Exclusion Criteria:
- craniofacial syndrome;
- segmental osseous genioplasty;
- previous osseous genioplasty;
- previous mandibular trauma;
- systemic disorders.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: PSI group
The patient specific implant (PSI) is used to completed the genioplasty.
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The patient specific implant is used to simultaneously complete the reposition and fixation of the chin.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Positional differences of the chin between the plan and postoperative results
Tidsramme: 2 weeks after the operation
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The coordinates of the centroid of three land points on the chin segment was used to calculate the position differences between the plan and postoperative results in X, Y and Z axis.
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2 weeks after the operation
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Orientation differences of the chin between the plan and postoperative results
Tidsramme: 2 weeks after the operation
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The coordinates of three independent points were used to define the orientation of the chin in 3D space.
The orientation differences were calculated in pitch (the rotation around the X axis), roll (the rotation around the Y axis), and yaw (the rotation around the Z axis).
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2 weeks after the operation
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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time consuming
Tidsramme: 3 days after the operation
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time spending for the virtual planning and the design of the PSI
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3 days after the operation
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economic consuming
Tidsramme: 3 days after the operation
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economic cost of the fabrication of the patient specific implant
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3 days after the operation
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Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- PSIcmfs03
Plan for individuelle deltakerdata (IPD)
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Legemiddel- og utstyrsinformasjon, studiedokumenter
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