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

Primary Purpose

Mandibular Fractures

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Control group without use of VSP

Treatment Group with use of VSP

About this trial

This is an interventional treatment trial for Mandibular Fractures

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

The University of Texas Health Science Center at HoustonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control Group

Treatment Group

Arm Description

Outcomes

Primary Outcome Measures

The time taken to complete an open reduction internal fixation (ORIF)

Secondary Outcome Measures

Number of participants with malocclusion

Number of participants with fractures that are not well aligned

Number of participants with infections

Full Information

NCT ID

NCT04283981

First Posted

February 19, 2020

Last Updated

May 27, 2022

Sponsor

The University of Texas Health Science Center, Houston

Collaborators

Stryker Instruments

1. Study Identification

Unique Protocol Identification Number

NCT04283981

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Recruiting

Study Start Date

January 24, 2021 (Actual)

Primary Completion Date

June 2023 (Anticipated)

Study Completion Date

June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The University of Texas Health Science Center, Houston

Collaborators

Stryker Instruments

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this trial is to compare operating room time between conventional treatment techniques (without Virtual surgical Planning (VSP)) versus use of VSP and surgically-guided techniques and to compare and contrast the effect of any other variables that might have an effect on the overall result

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Mandibular Fractures

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Control Group

Arm Type

Active Comparator

Arm Title

Treatment Group

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

Control group without use of VSP

Intervention Description

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)

Intervention Type

Device

Intervention Name(s)

Treatment Group with use of VSP

Intervention Description

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 Outcome Measure Information:

Title

The time taken to complete an open reduction internal fixation (ORIF)

Time Frame

End of dissection until final screws are placed,about 2-3 hours

Secondary Outcome Measure Information:

Title

Number of participants with malocclusion

Time Frame

1 week post surgery

Title

Number of participants with malocclusion

Time Frame

3 weeks post surgery

Title

Number of participants with malocclusion

Time Frame

6 weeks post surgery

Title

Number of participants with fractures that are not well aligned

Time Frame

1 week post surgery

Title

Number of participants with fractures that are not well aligned

Time Frame

3 weeks post surgery

Title

Number of participants with fractures that are not well aligned

Time Frame

6 weeks post surgery

Title

Number of participants with infections

Time Frame

1 week post surgery

Title

Number of participants with infections

Time Frame

3 weeks post surgery

Title

Number of participants with infections

Time Frame

6 weeks post surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Timothy Woernley, DDS

Phone

(713) 486-4310

Timothy.C.Woernley@uth.tmc.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Nagi Demian

Phone

(713) 500-7833

Nagi.Demian@uth.tmc.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Timothy Woernley, DDS

Organizational Affiliation

The University of Texas Health Science Center, Houston

Official's Role

Principal Investigator

Facility Information:

Facility Name

The University of Texas Health Science Center at Houston

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Timothy Woernley, DDS

Phone

713-486-4310

Timothy.C.Woernley@uth.tmc.edu

First Name & Middle Initial & Last Name & Degree

Nagi Demian

Phone

(713) 500-7833

Nagi.Demian@uth.tmc.edu

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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