Mandibular Slotplates

NCT03679377 | Unknown

• 1 other identifier: Mandi slot plates v 1.0
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Craniofacial Abnormalities

Keywords

Orthognathic surgical procedures; Osteosynthesis

Outcome Measures

Primary Outcomes (2)

• Feasebility of the slotprinciple

  yes or no

  during surgery

• Inclination of the screws

  Useful yes or no

  during surgery

Study Arms (1)

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

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.

Mandibular slotplate

Eligibility Criteria

• Age: 12 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients undergoing single osteotomy BSSO surgery

You may not qualify if:

• Concomitant surgeries at the same time.

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Study Sites (1)

universitair Ziekenhuis Brussel

Jette, Vlaams Brabant, 1090, Belgium

RECRUITING

MeSH Terms

Conditions

Craniofacial Abnormalities

Condition Hierarchy (Ancestors)

Musculoskeletal Abnormalities; Musculoskeletal Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Brandaan Zigterman, MD

  Universitair Ziekenhuis Brussel

  PRINCIPAL INVESTIGATOR

• Maurice Mommaerts, Prof Mult

  Universitair Ziekenhuis Brussel

  STUDY DIRECTOR

Central Study Contacts

Veerle Van Mossevelde, Datanurse

CONTACT

+3224763134; veerle.vanmossevelde@uzbrussel.be

Annelies De Cock, Datanurse

CONTACT

+3224779906; annelies.decock@uzbrussel.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Model Details: 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.

Study Record Dates

• First Submitted: September 19, 2018
• First Posted: September 20, 2018
• Study Start: November 7, 2018
• Primary Completion: December 31, 2019
• Study Completion: February 1, 2020
• Last Updated: August 28, 2019

Record last verified: 2019-08

Locations

BE (1)