Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT02913807 |
| Other study ID # |
H-34814 |
| Secondary ID |
|
| Status |
Withdrawn |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 2016 |
| Est. completion date |
March 2019 |
Study information
| Verified date |
January 2019 |
| Source |
Boston Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This study will test the accuracy of computerized custom mandibular reconstruction to
traditional methods of mandibular reconstruction using a vascularized osteocutaneous fibula
flap.
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.
