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Virtual Surgical Planning Systems in Mandibular Reconstruction (VP3D)

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ClinicalTrials.gov Identifier: NCT03869723
Recruitment Status : Completed
First Posted : March 11, 2019
Last Update Posted : March 12, 2019
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

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.

Condition or disease Intervention/treatment
Mandibular Neoplasms Procedure: Virtual planning using customized surgical devices Procedure: Conventional surgery

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Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Evaluation of Virtual Surgical Planning Systems and Customized Devices in Fibula Free Flap Mandibular Recontruction
Actual Study Start Date : November 1, 2017
Actual Primary Completion Date : November 30, 2017
Actual Study Completion Date : March 31, 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Conventional surgery
Classical surgery for mandibular reconstruction with fibula free flap
Procedure: Conventional surgery
Classical surgery for mandibular reconstruction with fibula free flap

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
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




Primary Outcome Measures :
  1. Comparison of the cephalometrics measurements between the virtual model and postoperative outcomes [ Time Frame: Six months after surgery ]

    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.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who underwent fibula free flap for mandibular reconstruction
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03869723


Locations
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France
Croix-Rousse Hospital - Hospices Civils de Lyon
Lyon, France, 69004
Sponsors and Collaborators
Hospices Civils de Lyon

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03869723     History of Changes
Other Study ID Numbers: CRC_GHN_2019_002
First Posted: March 11, 2019    Key Record Dates
Last Update Posted: March 12, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Mandibular Neoplasms
Jaw Neoplasms
Skull Neoplasms
Bone Neoplasms
Neoplasms by Site
Neoplasms
Bone Diseases
Musculoskeletal Diseases
Jaw Diseases
Mandibular Diseases
Stomatognathic Diseases