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Completed

NCT Number: NCT04283981

Comparison of Operating Room Time Length With the Use of Virtual Surgical Planning Versus Conventional Treatment of Mandible Fractures

The purpose of this trial is to compare operating room time between conventional treatment techniques [without Virtual surgical Planning (VSP)] versus treatment with use of Virtual surgical Planning (VSP) in patients that undergo mandibular reconstruction via open reduction internal fixation (ORIF).

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Key information

Conditions

Mandibular Fractures Craniocerebral Trauma Facial Injuries Fractures, Bone Jaw Fractures Maxillofacial Injuries Nervous System Diseases Skull Fractures Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient consent
  • Complex mandible fracture (at least two fractures) that require ORIF of at least one fracture. This will exclude condylar fractures

Exclusion criteria

  • Patient refusal to participate in study
  • Infected mandible fracture
  • Closed reduction treatment of mandible fracture
  • Fractures older than 2-3 weeks at the time of treatment
  • Other concomitant mid-facial bone fractures (ie, zygomaticomaxillary complex (ZMC), Lefort fractures)
  • Other etiologies than trauma of the mandibular fracture or pathologic fracture secondary to benign or malignant pathology that may require resection
  • Pregnant patients will NOT be excluded from the study
  • Co-morbidities (auto-immune disease, osteoporosis, titanium or metal allergy, uncontrolled diabetes (A1c greater than 8)

Treatment and study plan

Control group without use of VSP

Device

The control group will include patients that undergo mandibular reconstruction via open reduction internal fixation (intraoral or extraoral approach) in standard fashion (without virtual surgical planning assistance and occlusal splint)

Treatment Group with use of VSP

Device

The treatment group corresponds to patients undergoing mandibular reconstruction via open reduction internal fixation (intraoral or extraoral approach) utilizing virtual surgical planning via 3D Systems, bite registration and fabrication of occlusal splint via intraoral digital scanner, and mandibular hardware

Primary outcomes

  1. The Time Taken to Complete an Open Reduction Internal Fixation (ORIF)

    Time frame: from start of ORIF to end of ORIF (about 2-3 hours)

    The time taken to complete an Open Reduction Internal Fixation (ORIF) [referred to as the "plating time"] was defined as beginning after dissection was complete and fractures were initially reduced, and ending after all fracture sites were fixated with the final screw placed.

Secondary outcomes

  1. Number of Participants With Malocclusion

    Time frame: 1 week after ORIF

  2. Number of Participants With Malocclusion

    Time frame: 3 weeks after ORIF

  3. Number of Participants With Malocclusion

    Time frame: 6 weeks after ORIF

  4. Number of Participants With Fractures That Are Not Well Aligned

    Time frame: 1 week after ORIF

  5. Number of Participants With Fractures That Are Not Well Aligned

    Time frame: 3 weeks after ORIF

  6. Number of Participants With Fractures That Are Not Well Aligned

    Time frame: 6 weeks after ORIF

  7. Number of Participants With Infections

    Time frame: 1 week after ORIF

  8. Number of Participants With Infections

    Time frame: 3 weeks after ORIF

  9. Number of Participants With Infections

    Time frame: 6 weeks after ORIF

  10. Type of Archbars Used in ORIF

    Time frame: from start of ORIF to end of ORIF (about 2-3 hours)

    Archbars are used for fixating jaws during the treatment of mandible fractures. Archbars are anchored onto both jaws (that is, onto the maxillar/upper jaw, and onto the mandibular/lower jaw); therefore, each participant receives 2 arch bars, one for each jaw. Data are reported categorically as the type of arch bar received for a jaw.

  11. Number of Participants Whose Occlusal Splint Fit Appropriately

    Time frame: from start of ORIF to end of ORIF (about 2-3 hours)

  12. Type of Surgical Approach to the Fracture Site

    Time frame: from start of ORIF to end of ORIF (about 2-3 hours)

    The type of surgical approach to the fracture site is reported categorically as either extraoral or intraoral. This is counted based on each fracture approached surgically (a participant may have more than 1 approach if they had more than 1 fracture site).

  13. Number of Participants Who Required Intraoperative Surgical Revisions

    Time frame: from start of ORIF to end of ORIF (about 2-3 hours)

  14. Distance of Maximal Interincisal Opening

    Time frame: 6 weeks after ORIF

    Maximal interincisal opening is the maximum distance a person can open their mouth between their upper and lower incisors measured in millimeters.

  15. Number of Participants With Hardware Failure

    Time frame: from baseline to 6 weeks after ORIF

    Number of Participants with hardware failure as defined as plate fracture or screw loosening

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • Stryker Instruments

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 25, 2020
Registry last updated
Jun 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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