CTA Perforator Localization for Virtual Surgical Planning of Osteocutaneous Fibular Free Flaps in Head and Neck Reconstruction

Overview

  • Study type

    Observational
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Rochester, Minnesota: 17-010425
    Sponsor Protocol Number: 17-010425

About this study

The purpose of this study is to prospectively investigate the accuracy and reliability of the computed tomographic angiography (CTA) perforator tracing method across two high volume tertiary care institutions currently utilizing virtual surgical planning (VSP) for osteocutaneous fibular free flap reconstructions (Mayo Clinic Rochester / University of Florida-Jacksonville).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

  • Osteocutaneous fibular free flap reconstruction being performed for a head and neck reconstructive defect 
  • Adequate clinical documentation of intraoperative perforator locations and need for intraoperative modification of virtual surgical plan within retrospectively identified patients 
  • A minimum postoperative follow up of 30 days to assess for flap related complications and outcomes

Exclusion Criteria:

  • Preoperative imaging modality other than CTA utilized to verify lower extremity three vessel run-off 
  • Head and neck defects not necessitating composite reconstruction with bone and a soft tissue skin paddle 
  • Lack of patient three vessel run-off in the lower extremity precluding use of fibular free flap reconstruction 
  • Inadequate clinical documentation of intraoperative perforator locations for retrospectively identified patients 
  • Inadequate documentation of need to modify intraoperative virtual surgical plan for retrospectively identified patients 
  • Less than 30 days of postoperative follow up to assess flap related outcomes.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Kevin Arce, D.M.D., M.D.

Contact us for the latest status

Contact information:

Kevin Arce Castro D.M.D., M.D.

(507)538-1943

Arce.Kevin@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20391197

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