3D Printed Models for Mandibular Fracture Repair

Part of paid clinical trials in Cincinnati, Ohio.

Sponsor
University of Cincinnati
Study ID
NCT05733221
Status
Enrolling By Invitation

Conditions

  • Mandible Fracture
  • Maxillofacial Trauma

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • 3D Printed Model — DEVICE
    3D Printed Model generated pre-operatively of the patients mandible.

Study Details

The investigators will test the hypothesis that patients randomized to the intervention (3D printing with pre-bent plate) arm have less operative room time and less time for the critical part of the procedure than patients in the control arm (no 3D printing, current standards of care). Personalized medicine and care for fracture treatment.

Key Dates

Start date
Mar 11, 2023
Status verified
May 2025
Primary completion
Jun 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 3D Model Generated
    Patient will undergo an Open Reduction and Internal Fixation preformed by a surgeon who had pre-operative access to a 3D model printed to help pre-bend hardware.
  • No Intervention: Normal Standards of Care without Aide of Model
    Patient will undergo standard Open Reduction and Internal Fixation by a surgeon who did not have a pre-operative 3D model.

Primary Outcome Measure

Total time in the OR [ Time Frame: Total procedural time ]

Locations (2)

FacilityCityStateZIPSite coordinators
UC Health Holmes HospitalCincinnatiOhio45220-
University of Cincinnati Medical CenterCincinnatiOhio45219-

Find similar trials in Cincinnati, OH

By research site
UC Health Holmes Hospital· Cincinnati, OHUniversity of Cincinnati Medical Center· Cincinnati, OH

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