- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01056302
Advanced Visuohaptic Surgical Planning for Trauma Surgery
2. juli 2020 opdateret af: VA Office of Research and Development
This study proposes to develop a computer-based software tool that will allow surgeons to plan and simulate surgery for patients with jaw trauma.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
The proposed tool will allow surgeons from different specialties to simulate, plan and iterate on complex procedures based on individual patient data in 3-D from a CT scan.
The software will allow surgeons to both see and feel the results of their interventions - for example, the quality of the bite or bone alignment of a reconstructed jaw following severe trauma - before the actual surgery, leading to better planning, fewer errors, shortened surgery time and improved outcomes for the patients.
The purpose of this study is the evaluation of a visuohaptic planning system for mandibular trauma surgery that is based on interactive manipulation of CT data.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
California
-
San Francisco, California, Forenede Stater, 94121
- VA Medical Center, San Francisco
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Study population will veterans who present to the Oral/Maxillofacial Surgery Clinic at the San Francisco VA Medical Center.
The study will use pre-existing data from patients undergoing reconstructive facial surgery at the San Francisco VA with clinic indications that require preoperative CT scans and preoperative radiographs as well as model casts.
Beskrivelse
Inclusion Criteria:
- Craniofacial deformity, including post-traumatic, congenital or acquired deformity
- Patients who have already have surgery because there was a clinical indication for surgical correction
Exclusion Criteria:
- No craniofacial deformity
- No clinical indication for surgical correction
- Contraindication for surgical correction
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
---|---|
Group 1
15 patients who underwent surgical repair of mandibular fractures at San Francisco VA Medical Center
|
Patients will undergo whatever needed surgical repair of maxillofacial trauma that is necessary.
Records such as CT imaging and plaster models of the jaws will be utilized in the standard way to plan and carry out the surgery.
The CT scan will also be used within the visuohaptic computational environment to develop and evaluate the user interface.
The amount of time taken to work up and plan surgery using standard surgical practice and using the computational platform will be compared.
Real surgical outcome will be compared to the simulated surgical outcome using the proposed software tool.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Percentage of Deviation From Actual Surgical Outcome During Virtual Repair of Mandibular Fractures, Using the Novel Visuohaptic Computational Platform That Was Developed by the Investigators
Tidsramme: 6 months
|
The virtual surgical outcome was compared to the actual surgical outcome.
This was accomplished by measuring distances (mm) and angles between specific mandibular anatomic points in the virtual environment and comparing it to the same distances (mm) and angles between specific mandibular anatomic points in the actual surgical outcome, as seen in a 3D rendering derived from the patient's postoperative CT scan.
The actual surgical repair was considered to be the gold standard.
A deviation of more than 10% between the virtual surgical repair and the actual surgical repair was considered to be above threshold (inaccurate virtual fracture repair).
|
6 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Development and Evaluation of Automation Features for the Visuohaptic Virtual Surgery Planning Environment
Tidsramme: 3 years
|
The addition of automation features for the visuohaptic virtual surgical planning environment was envisioned to make it possible to predict the number, type, size, and position of reconstruction hardware (bone plates and screws) that would best fit the virtually repaired mandibular fractures.
The goal was to compare the hardware configuration selected and used in the actual surgical repair for the 3 participating patients with what the software predicted.
Unfortunately, the software development proved to be difficult to add this automated feature.
|
3 years
|
Implementation and Test of the Telemedicine Prototype
Tidsramme: 3 years
|
Measurement of the accuracy of the virtual surgical repair generated by the surgeon operating the software when a remote surgeon digitally sends a CT scan of a patient with an acute mandibular fracture(s).
The telemedicine interface would require an automated method to segment the CT scan into the fractured components.
The operator would manipulate the bone fractures, select the hardware type and size for "best fit", and generate a report back to the remote surgeon.
|
3 years
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Rebeka Silva, DMD, VA Medical Center, San Francisco
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Schvartzman SC, Silva R, Salisbury K, Gaudilliere D, Girod S. Computer-aided trauma simulation system with haptic feedback is easy and fast for oral-maxillofacial surgeons to learn and use. J Oral Maxillofac Surg. 2014 Oct;72(10):1984-93. doi: 10.1016/j.joms.2014.05.007. Epub 2014 May 24.
- Forsslund J, Chan S, Selesnick J, Salisbury K, Silva RG, Blevins NH. The effect of haptic degrees of freedom on task performance in virtual surgical environments. Stud Health Technol Inform. 2013;184:129-35.
- Girod S, Schvartzman SC, Gaudilliere D, Salisbury K, Silva R. Haptic feedback improves surgeons' user experience and fracture reduction in facial trauma simulation. J Rehabil Res Dev. 2016;53(5):561-570. doi: 10.1682/JRRD.2015.03.0043.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. november 2011
Primær færdiggørelse (Faktiske)
1. december 2014
Studieafslutning (Faktiske)
1. februar 2016
Datoer for studieregistrering
Først indsendt
22. januar 2010
Først indsendt, der opfyldte QC-kriterier
22. januar 2010
Først opslået (Skøn)
26. januar 2010
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
7. juli 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
2. juli 2020
Sidst verificeret
1. juni 2020
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- F7124-R
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
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