NCT03869723

Brief Summary

The purpose of this study was to evaluate the accuracy of virtual planning using customized surgical devices (VP3D) in fibula free flap mandibular reconstruction. Virtual planning was compared to postoperative scans using cephalometric and three-dimensional (3D) measurements. Operative times of both VP3D and conventional surgery groups were compared.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2017

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2018

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 8, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 11, 2019

Completed
Last Updated

March 12, 2019

Status Verified

March 1, 2019

Enrollment Period

29 days

First QC Date

February 8, 2019

Last Update Submit

March 11, 2019

Conditions

Mandibular Neoplasms

Outcome Measures

Primary Outcomes (1)

  • Comparison of the cephalometrics measurements between the virtual model and postoperative outcomes

    The virtual model obtained using preoperative surgical planning will be compared with postoperative outcomes derived from facial bone scans conducted on all VP3D group patients 6 months after surgery (MIMICS INNOVATION suite 2.1 software, MATERIALISE, Leuven, Belgium). The cephalometrics measurements (in mm) between the virtual model and postoperative outcomes will be compared.

    Six months after surgery

Study Arms (2)

Conventional surgery

Classical surgery for mandibular reconstruction with fibula free flap

Procedure: Conventional surgery

Virtual planning

Fibula free flap in mandibular reconstruction using preoperative virtual planning, cutting guides and osteosynthesis plates. Preoperative modeling was conducted by obtaining scans of patient maxillofacial skeleton and angioscans of the lower extremities. The planning phase was then carried out by the surgeon and the engineer (from MATERIALISE, Leuven, Belgium) so as to define the clinical and technical parameters of the reconstruction. This stage consisted of discussing and determining osteotomy lines, donor side, anastomosis site, and overall reconstruction contour. Resection was decided by the surgeon. 3D modeling and the manufacture of cutting guides and customized osteosynthesis plates were then undertaken

Procedure: Virtual planning using customized surgical devices

Interventions

Virtual planning using customized surgical devicesPROCEDURE

Preoperative modeling was conducted by obtaining scans of patient maxillofacial skeleton and angioscans of the lower extremities. The planning phase was then carried out by the surgeon and the engineer (from MATERIALISE, Leuven, Belgium) so as to define the clinical and technical parameters of the reconstruction. This stage consisted of discussing and determining osteotomy lines, donor side, anastomosis site, and overall reconstruction contour. Resection was decided by the surgeon. 3D modeling and the manufacture of cutting guides and customized osteosynthesis plates were then undertaken

Virtual planning
Conventional surgeryPROCEDURE

Classical surgery for mandibular reconstruction with fibula free flap

Conventional surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who underwent fibula free flap for mandibular reconstruction

You may qualify if:

  • Patients who underwent fibula free flap for mandibular reconstruction
  • Patient ≥18 years old
  • patient alive 6 months after completion of treatment

You may not qualify if:

  • Patient without post-operative scan evaluation
  • Patient with a chirurgical contraindication
  • Pregnant or nursing woman
  • Adult requiring protection (guardianship, supervision)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Croix-Rousse Hospital - Hospices Civils de Lyon

Lyon, 69004, France

Location

Related Publications (1)

  • Blanc J, Fuchsmann C, Nistiriuc-Muntean V, Jacquenot P, Philouze P, Ceruse P. Evaluation of virtual surgical planning systems and customized devices in fibula free flap mandibular reconstruction. Eur Arch Otorhinolaryngol. 2019 Dec;276(12):3477-3486. doi: 10.1007/s00405-019-05625-z. Epub 2019 Sep 9.

    PMID: 31501989DERIVED

MeSH Terms

Conditions

Mandibular Neoplasms

Condition Hierarchy (Ancestors)

Jaw NeoplasmsSkull NeoplasmsBone NeoplasmsNeoplasms by SiteNeoplasmsBone DiseasesMusculoskeletal DiseasesJaw DiseasesMandibular DiseasesStomatognathic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 8, 2019

First Posted

March 11, 2019

Study Start

November 1, 2017

Primary Completion

November 30, 2017

Study Completion

March 31, 2018

Last Updated

March 12, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)