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Traditional Versus Computerized Mandibular Reconstruction

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ClinicalTrials.gov Identifier: NCT02913807
Recruitment Status : Withdrawn (Study was ended due to lack of available participants who met criteria.)
First Posted : September 26, 2016
Last Update Posted : January 31, 2019
Sponsor:
Information provided by (Responsible Party):
Boston Medical Center

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.

Condition or disease Intervention/treatment Phase
Free Tissue Transfer Mandible Reconstruction Computerized Customization Procedure: Customized Jigs and Plates Procedure: Hand Contoured Osteotomies and Reconstruction Bars Not Applicable

Detailed Description:

Since the introduction of microvascular repair and the refinement in technique, free tissue transfer has become the gold standard of head and neck reconstruction. Outcomes of free tissue transfer have been also shown to be financially favorable for the healthcare system while improving the quality of life of the patient. The fibula osteocutaneous free flap has established itself as the workhorse for mandibular reconstruction, providing a large amount of bone with an inherently thick cortical stock that makes it an ideal option for creating a new mandible.

Reconstruction of the mandible utilizes a locking reconstruction plate to secure the vascularized bone into position. Paramount to a successful mandibular reconstruction is the accurate contouring of the plate to restore the aesthetic projections and occlusive status of the patient. Computer-assisted, customized reconstruction plate and along with osteotomy jigs (Stryker, CMF) has in-use for mandibular reconstruction. The customized reconstruction plate is similar to the traditional plates except that instead of having to bend them to the proper position, they are manufactured in the properly bent configuration. The stated benefits of such a device would be more accurate contouring resulting in more accurate restorations of the aesthetic projections of the face, better postoperative occlusive status, and a decrease in operative time.

This pilot study is being proposed to determine the variation in mandibular reconstructive outcomes when comparing conventional techniques of manually bent stock reconstruction plates to new methods utilizing pre-surgical planning and customized/patient specific plating. While the customized reconstruction plates and jigs have been studied, there is no head-to-head comparison versus a traditional, hand-bent plate and manually-cut osteotomies. The most commonly used technique at Boston Medical Center is to bend the plates manually, however both techniques are used and can be considered standard of care.

All patients who qualify for reconstruction after tumor ablation, per the investigator institution's tumor board recommendations will be eligible. Recruitment of subjects and enrollment will adhere to IRB requirements. Patients enrolled in the pilot study will be randomized into free hand and computerized groups (N=10 in each arm). All patients will undergo preoperative photographs in standard formats. Those in the free-hand group will undergo mandibular reconstruction using a fibula free flap. The bar will be hand contoured at the time of surgery and the osteotomies will be estimated and performed by hand by the PI per his usual technique. Those undergoing computerized reconstruction will undergo presurgical computerized planning of osteotomies and the reconstruction bar. The remainder of the procedure will go on per the PI's usual procedure for mandibular reconstruction using a fibula free flap. Postoperative treatment between the two groups will not differ from the current standard of care and will occur according to the PI's postoperative protocol. At six months out, patients will undergo CT scanning to evaluate the osteotomy distance and amount of bony contact that is present. Measurements at the outer and inner gaps will be captured as well as the averages between the two. All subjects in each arm will be matched for number of osteotomies and amount of bony defect per procedure. Information regarding length of the total procedure as well as the time specific to the reconstruction and ischemia time (the time from clamping the blood vessels when taking the flap from the leg and then reconnecting them in the neck, and thus re-vascularizing the flap) of the flaps will be collected. Also cephalometric analysis will be performed to evaluate the aesthetic results. See data section for details.

All data collected will be organized and have statistical analysis performed between the two groups. Significant differences will be reported.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Utility and Effectiveness of Computer-Assisted, Customized Reconstruction of the Mandible
Actual Study Start Date : December 2016
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Traditional Reconstruction
This cohort will be reconstructed using hand contoured osteotomies and reconstruction bars
Procedure: Hand Contoured Osteotomies and Reconstruction Bars
This will be the traditional method of hand-conjuring the bar and bony sites.

Experimental: Computerized Custom
This cohort will be reconstructed using customized computer-modeled titanium locking customized jigs and plates for the osteotomies.
Procedure: Customized Jigs and Plates
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.




Primary Outcome Measures :
  1. Postoperative Osteotomy Gaps as measured via CT measurements (distance=cm) [ Time Frame: 6 months postop ]
    The osteotomy gaps will be measured and an average on each site will be calculated.

  2. Reconstruction Bar [ Time Frame: 6 months postop ]
    The projection and known facial landmarks will be compared suing pre- and post-operative photographs.


Secondary Outcome Measures :
  1. Cost and Time [ Time Frame: Intraoperative ]
    The cost-time differences in the OR will be calculated between cohorts



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02913807


Locations
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United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston Medical Center
Investigators
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Principal Investigator: Waleed Ezzat, MD Boston Medical Center
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Responsible Party: Boston Medical Center
ClinicalTrials.gov Identifier: NCT02913807    
Other Study ID Numbers: H-34814
First Posted: September 26, 2016    Key Record Dates
Last Update Posted: January 31, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No