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Mandibular Slotplates

Primary Purpose

Craniofacial Abnormalities

Status

Unknown status

Phase

Not Applicable

Locations

Belgium

Study Type

Interventional

Intervention

Mandibular slotplate

About this trial

This is an interventional device feasibility trial for Craniofacial Abnormalities focused on measuring Orthognathic surgical procedures, Osteosynthesis

Eligibility Criteria

12 Years - 50 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

• Patients undergoing single osteotomy BSSO surgery

Exclusion Criteria:

• Concomitant surgeries at the same time.

Sites / Locations

universitair Ziekenhuis BrusselRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Mandibular slotplate

Arm Description

Mandibular slotplates are placed during BSSO surgery and their clinical usefullness is tested. Afterwards the plates are removed and the osteotomy is fixated by three bicortical screws.

Outcomes

Primary Outcome Measures

Feasebility of the slotprinciple

yes or no

Inclination of the screws

Useful yes or no

Secondary Outcome Measures

Full Information

NCT ID

NCT03679377

First Posted

September 19, 2018

Last Updated

August 23, 2019

Sponsor

Universitair Ziekenhuis Brussel

1. Study Identification

Unique Protocol Identification Number

NCT03679377

Brief Title

Mandibular Slotplates

Official Title

Mandibular Slotplates

Study Type

Interventional

2. Study Status

Record Verification Date

August 2019

Overall Recruitment Status

Unknown status

Study Start Date

November 7, 2018 (Actual)

Primary Completion Date

December 31, 2019 (Anticipated)

Study Completion Date

February 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Universitair Ziekenhuis Brussel

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

A new osteosynthesis system for orthognathic surgery was proposed.This system allows small intra-operative adjustments of the bone fragments during the osteosynthesis phase of the operation (also known as the slot principle). Another possible advantage are the slant screw holes with chamfered ridges allowing easy placements of the screws via the small incision wound without undercuts in between the plate and the screwheads.

Detailed Description

Initial slotplates were developed for Le Fort I osteotomies, zygoma 'sandwich 'osteotomies and genioplasties. Those plates allowed for the slot principle to be performed during orthognathic surgery. Mandibular slotplates for bilateral sagittal split osteotomy (BSSO) were recently designed. The aim of the study is to evaluate their clinical usefulness and the applicability of the slot principle with these plates in BSSO.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Craniofacial Abnormalities

Keywords

Orthognathic surgical procedures, Osteosynthesis

7. Study Design

Primary Purpose

Device Feasibility

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Mandibular slotplates are placed during the osteosynthesis phase of the BSSO surgery. After clinical testing during the surgery the plates are removed and the osteotomy is fixated with bicortical screws.

Masking

None (Open Label)

Allocation

N/A

Enrollment

9 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Mandibular slotplate

Arm Type

Experimental

Arm Description

Mandibular slotplates are placed during BSSO surgery and their clinical usefullness is tested. Afterwards the plates are removed and the osteotomy is fixated by three bicortical screws.

Intervention Type

Device

Intervention Name(s)

Mandibular slotplate

Intervention Description

Mandibular slotplates are placed during the osteosynthesis phase of the BSSO surgery. After testing of the plates they are removed and the osteotomy is fixated with three bicortical screws.

Primary Outcome Measure Information:

Title

Feasebility of the slotprinciple

Description

yes or no

Time Frame

during surgery

Title

Inclination of the screws

Description

Useful yes or no

Time Frame

during surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: • Patients undergoing single osteotomy BSSO surgery Exclusion Criteria: • Concomitant surgeries at the same time.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Veerle Van Mossevelde, Datanurse

Phone

+3224763134

veerle.vanmossevelde@uzbrussel.be

First Name & Middle Initial & Last Name or Official Title & Degree

Annelies De Cock, Datanurse

Phone

+3224779906

annelies.decock@uzbrussel.be

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Brandaan Zigterman, MD

Organizational Affiliation

Universitair Ziekenhuis Brussel

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Maurice Mommaerts, Prof Mult

Organizational Affiliation

Universitair Ziekenhuis Brussel

Official's Role

Study Director

Facility Information:

Facility Name

universitair Ziekenhuis Brussel

City

Jette

State/Province

Vlaams Brabant

ZIP/Postal Code

1090

Country

Belgium

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Veerle Van Mossevelde

Phone

+3224763134

veerle.vanmossevelde@uzbrussel.be

12. IPD Sharing Statement

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Mandibular Slotplates

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