Traditional Versus Computerized Mandibular Reconstruction

NCT02913807 | Withdrawn

• 1 other identifier: H-34814
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This study will test the accuracy of computerized custom mandibular reconstruction to traditional methods of mandibular reconstruction using a vascularized osteocutaneous fibula flap.

Conditions

Free Tissue Transfer; Mandible Reconstruction; Computerized Customization

Outcome Measures

Primary Outcomes (2)

• Postoperative Osteotomy Gaps as measured via CT measurements (distance=cm)

  The osteotomy gaps will be measured and an average on each site will be calculated.

  6 months postop

• Reconstruction Bar

  The projection and known facial landmarks will be compared suing pre- and post-operative photographs.

  6 months postop

Secondary Outcomes (1)

• Cost and Time

  Intraoperative

Study Arms (2)

Traditional Reconstruction

PLACEBO COMPARATOR

This cohort will be reconstructed using hand contoured osteotomies and reconstruction bars

Procedure: Hand Contoured Osteotomies and Reconstruction Bars

Computerized Custom

EXPERIMENTAL

This cohort will be reconstructed using customized computer-modeled titanium locking customized jigs and plates for the osteotomies.

Procedure: Customized Jigs and Plates

Interventions

Customized Jigs and Plates PROCEDURE

The titanium locking reconstruction plates will be prefabricated based on the preoperative CT scans. Prior to procedure, customized planning for osteotomies will generate the prefabricated jigs.

Computerized Custom

Hand Contoured Osteotomies and Reconstruction Bars PROCEDURE

This will be the traditional method of hand-conjuring the bar and bony sites.

Traditional Reconstruction

Eligibility Criteria

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

You may qualify if:

• All patients who will undergo mandibular reconstruction at the Boston Medical Center using a fibula free flap.

You may not qualify if:

• Patients under the age of 18
• Prisoners
• Individuals with large lesions that will affect preoperative landmark assessment.

Sponsors & Collaborators

• Boston Medical Center: lead

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Interventions

Bone Plates

Intervention Hierarchy (Ancestors)

Internal Fixators; Prostheses and Implants; Equipment and Supplies; Orthopedic Fixation Devices; Orthopedic Equipment; Surgical Equipment; Surgical Fixation Devices

Study Officials

• Waleed Ezzat, MD

  Boston Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2016
• First Posted: September 26, 2016
• Study Start: December 1, 2016
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: January 31, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)