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

NCT04283981 | Completed Results FDA Device

• 1 other identifier: HSC-DB-19-1074
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Mandibular Fractures

Outcome Measures

Primary Outcomes (1)

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

  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.

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

Secondary Outcomes (15)

• Number of Participants With Malocclusion

  1 week after ORIF

• Number of Participants With Malocclusion

  3 weeks after ORIF

• Number of Participants With Malocclusion

  6 weeks after ORIF

• Number of Participants With Fractures That Are Not Well Aligned

  1 week after ORIF

• Number of Participants With Fractures That Are Not Well Aligned

  3 weeks after ORIF

Study Arms (2)

Control Group

ACTIVE COMPARATOR

Device: Control group without use of VSP

Treatment Group

EXPERIMENTAL

Device: Treatment Group with use of VSP

Interventions

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)

Control Group

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

Treatment Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• Stryker Instruments: collaborator

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Mandibular Fractures

Interventions

Control Groups

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Results Point of Contact

• Title: Simon Young
• Organization: The University of Texas Health Science Center at Houston

simon.young@uth.tmc.edu

(713) 486-2568

Study Officials

• Timothy Woernley, DDS

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 19, 2020
• First Posted: February 25, 2020
• Study Start: January 24, 2021
• Primary Completion: October 31, 2022
• Study Completion: November 10, 2022
• Last Updated: June 20, 2024
• Results First Posted: June 20, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)