Mandibular Slotplates | NCT03679377

Studies
Mandibular Slotplates

NCT03679377

Sponsor

Universitair Ziekenhuis Brussel

Status

Unknown status

Last Update Posted

Aug 28, 2019Actual

Enrollment

9Estimated

Phase

Not Applicable

Conditions

Craniofacial Abnormalities

Interventions

Mandibular slotplate

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 7, 2018Actual

Primary Completion Date

Dec 31, 2019Estimated

Completion Date

Feb 1, 2020Estimated

First Submitted Date

Sep 19, 2018

First Submission Date that Met QC Criteria

Sep 19, 2018

First Posted Date

Sep 20, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 23, 2019

Last Update Posted Date

Aug 28, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Veerle Van Mossevelde, Director, Universitair Ziekenhuis BrusselPrincipal Investigator

Lead Sponsor

Universitair Ziekenhuis BrusselOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

9Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Mandibular slotplate	Experimental	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.	Device: Mandibular slotplate

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Mandibular slotplate	Device	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Feasebility of the slotprinciple	yes or no	during surgery
Inclination of the screws	Useful yes or no	during surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

• Patients undergoing single osteotomy BSSO surgery

Exclusion Criteria:

• Concomitant surgeries at the same time.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

50 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Veerle Van Mossevelde, Datanurse	Contact	+3224763134		veerle.vanmossevelde@uzbrussel.be
Annelies De Cock, Datanurse	Contact	+3224779906		annelies.decock@uzbrussel.be

Overall Officials

Name	Affiliation	Role
Brandaan Zigterman, MD	Universitair Ziekenhuis Brussel	Principal Investigator
Maurice Mommaerts, Prof Mult	Universitair Ziekenhuis Brussel	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
universitair Ziekenhuis Brussel	Recruiting	Jette	Vlaams Brabant	1090	Belgium

Condition Browse Module

MeSH Terms

ID	Term
D019465	Craniofacial Abnormalities

Ancestor Terms

ID	Term
D009139	Musculoskeletal Abnormalities
D009140	Musculoskeletal Diseases
D000013	Congenital Abnormalities
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention 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.