Mandibular InjuriesNCT03054012
Accuracy and Outcome of Computer-assisted Surgery for Bony Micro-vascular Reconstruction in the Head and Neck Region
An observational study of Mandibular Injuries, run by AZ Sint-Jan AV.
Trial summary
Background: Functional and aesthetic reconstruction of mandibular defects due to tumour invasion, osteoradio- or chemonecrosis or trauma are challenging. Surgeons aim to achieve a good anatomic and symmetric reconstruction with stable occlusion and condylar position. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Mandibular Injuries
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Oct 2016to Feb 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients undergoing bony reconstruction by free vascularised flap between January 2013 and August 2016 will be included
Who may be able to join
- patients of all ages
- patients of both genders
- patients requiring mandibular reconstruction due to tumour invasion, osteoradionecrosis, osteochemonecrosis or trauma
- all patients undergoing bony reconstruction by free vascularised flap
- all patients treated between January 2013 and August 2016
- all patients where CAS was applied
Who cannot join
- all patients not eligible according to abovementioned criteria
About this study
Background:
Functional and aesthetic reconstruction of mandibular defects due to tumour invasion, osteoradio- or chemonecrosis or trauma are challenging. Surgeons aim to achieve a good anatomic and symmetric reconstruction with stable occlusion and condylar position. Classically this was obtained by (pre)bending a reconstruction plate, and providing osteotomies at the vascularized free flap. Today there is the availability of CAD-CAM software enabling a preoperative planning based on 3D models. This computer-assisted surgery (CAS) procedure is said to improve accuracy of the postoperative result, as well as a reduce ischemia time. However, there is a need for objective analysis of the accuracy of CAS, as well as the effective reduction in operating time and financial implication.
Read more
Study design:
Retrospective study.
All patients undergoing bony reconstruction by free vascularised flap between January 2013 and August 2016 will be included. Accuracy will be measured between the planned and actual result, through segmentation of the mandible in Brainlab software. Parameters regarding ischemic time and financial cost will be obtained from the medical files.
- Conditions
- Mandibular Injuries
- Keywords
- CAD-CAM software, accuracy, head and neck region, mandibular reconstruction
- Medical subject headings
- Mandibular Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| CAS group | computer-assisted surgery group |
What is being measured
The primary outcome is the main question the study is designed to answer.
accuracy of planned and actual result, through segmentation of mandibles Brainlab software
Measured: 6 months postoperative
Secondary outcomes (2)
ischemia time
Measured: perioperative
financial implication
Measured: preoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2017
- Study startOct 2016
- Primary completionFeb 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mandibular InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- AZ Sint-Jan AV
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Johan Abeloos, AZ Sint-Jan AV
- Investigators
- Johan Abeloos, MD, Principal investigator, Head of department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03054012
- Sponsor's protocol ID
- B0492017629990
- Status last verified
- Jan 2021
- First submitted
- 13 Feb 2017
- Last updated
- 19 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy and Outcome of Computer-assisted Surgery for Bony Micro-vascular Reconstruction in the Head and Neck Region
- ClinicalTrials.gov ID
- NCT03054012
- Acronym / sponsor ID
- B0492017629990
- Conditions
- Mandibular Injuries
- Keywords
- CAD-CAM software, accuracy, head and neck region, mandibular reconstruction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- AZ Sint-Jan AVUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 15 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
Functional and aesthetic reconstruction of mandibular defects due to tumour invasion, osteoradio- or chemonecrosis or trauma are challenging. Surgeons aim to achieve a good anatomic and symmetric reconstruction with stable occlusion and condylar position. Classically this was obtained by (pre)bending a reconstruction plate, and providing osteotomies at the vascularized free flap. Today there is the availability of CAD-CAM software enabling a preoperative planning based on 3D models. This computer-assisted surgery (CAS) procedure is said to improve accuracy of the postoperative result, as well as a reduce ischemia time. However, there is a need for objective analysis of the accuracy of CAS, as well as the effective reduction in operating time and financial implication.
Study design:
Retrospective study.
All patients undergoing bony reconstruction by free vascularised flap between January 2013 and August 2016 will be included. Accuracy will be measured between the planned and actual result, through segmentation of the mandible in Brainlab software. Parameters regarding ischemic time and financial cost will be obtained from the medical files.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CAS group | – | –computer-assisted surgery group |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients undergoing bony reconstruction by free vascularised flap between January 2013 and August 2016 will be included
Key inclusion criteria (6 listed)
- patients of all ages
- patients of both genders
- patients requiring mandibular reconstruction due to tumour invasion, osteoradionecrosis, osteochemonecrosis or trauma
- all patients undergoing bony reconstruction by free vascularised flap
- all patients treated between January 2013 and August 2016
Key exclusion criteria (1 listed)
- all patients not eligible according to abovementioned criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
accuracy of planned and actual result, through segmentation of mandibles Brainlab software
Time frame: 6 months postoperative
2 secondary outcomes
ischemia time
Time frame: perioperative
financial implication
Time frame: preoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johan Abeloos, MD principal investigator
Head of department
Questions about this trial
What is this clinical trial studying?
An observational study of Mandibular Injuries, run by AZ Sint-Jan AV.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
accuracy of planned and actual result, through segmentation of mandibles Brainlab software (time frame: 6 months postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2021.