Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT05715359 |
| Other study ID # |
Standardized osteotomy guide |
| Secondary ID |
|
| Status |
Enrolling by invitation |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
October 1, 2023 |
| Est. completion date |
December 2027 |
Study information
| Verified date |
April 2024 |
| Source |
Lund University Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The aim of the present project is to evaluate the outcome from reconstruction of the jaws,
with a standardized simplified technique, after a continuous defect.
The primary objective is to measure recurrence of the tumour is present as a marking for
insufficient resection margins. Secondary objectives are measures of survival of transplanted
tissues, registered complications at follow-up and measures of healing between segments of
transplanted bone (bone bridging).
Description:
Subjects The participants in this retrospective survey were consecutive head- and neck
malignancy patients referred 2002-2021 to Skåne University Hospital, Lund, Sweden with an
osseous proximity or malignancy. The treatment consisted of combined surgical resection and
radiotherapy. Patients will be identified through the use of ICD-coding. All patients
included underwent a primary functional and aesthetical reconstruction of continuous defects
of the jaws with free vascularized tissue transfer adopted to the area of resection with the
aid of a standardized osteotomy guide. The subjects eligible for inclusion in this project
should present at least 1-year postoperative follow-up.
Patients eligible for inclusion will be notified in newspaper announcement. One announcement
in a national newspaper and one announcement in the member newspaper of the Association for
oral and neck cancer patients. Patients that are not agreeing to take part in this project
are expected to declare this to the primary investigator. A drop-out analysis will be
performed on 30 of the not included subjects according to age and gender.
Surgical Method Reconstruction of resected osseous anatomy was performed on the same occasion
as tumour resection. Increased resection margins were decided after marginal intraoperative
frozen autopsies. The reconstruction was performed aiming for maximal function with the best
possible aesthetic outcome. All patients were initially planned to finalize the
reconstructive phase with a dental rehabilitation of dentition lost during the oncological
treatment. When applicable, a full dental rehabilitation was performed at least 12 months
after resection.
Surgically, a non-customized template with dimensions taken from The Brånemark Novum® concept
was used. Hence, the in-house template and cutting guide design was based upon a mean
dimension of the size and form in a fully-grown individual. A sectioning of the transplant
into three pieces, one frontal and two lateral, for reconstruction of the mandibular body was
used as the base for the design. The angle between the segments was designed into aslant of
thirty degrees.
The template and cutting guide were initially designed for mandibular reconstruction with an
osseo-musculo-cuttaneous vascularized fibula graft. With time, the design was also suitable
and used for reconstruction of maxillary and midface reconstruction and in cases with other
flaps, like the tip and lateral rim of scapula.
Gradually, the cutting guide for the mandibular body angle was also usable when
reconstructing the angle between the body and ramus of the mandible. Further, the angle of
the guide was also found to be usable for a reconstruction of the maxillary base at the level
suitable to a prosthetic reconstruction of the alveolar process and maxillary dentition to
fit a mandibular dentition.
From a biomechanical aspect, the transplant was fixated to the anatomical region with a load
sharing principle, meaning osteosynthesis not overbridging the segments but only connecting
them. Thus, the transplanted bone was partly loaded to catalyse the osteogenesis. For the
same reason, the remaining osseous tissues were, in accordance to a previous study, handled
predominately without stripping of the periosteum.
All subjects were treated with postoperative RT, having implant supported dental
rehabilitation to be performed in radiated tissues. When applicable, dental rehabilitation
begun no earlier than 1 year after tumour resection and after radiographic verification of
bone bridging between transplanted bone segments. To improve the healing capacity, hyperbaric
oxygene therapy (HBO) was performed at a daily basis four weeks before and two weeks after
implant insertion. Ten days per oral antibiotic was given with start two days prior to
implant insertion. Implants were loaded six months after insertion.
Variables and data collection methods Registrations from patient journals and radiographs
will include the following variables
1. Survival (patient).
2. Recurrent tumour.
3. Complications (including tissue survival).
4. Function.
5. Healing of bone segment (bone bridging).
6. Age.
7. Gender.
8. Time since tumour resection.
9. Level of rehabilitation (e.g. dental).
10. Jaw movements (range).
11. Pain.
12. Any problems with per oral nutrition.
The recordings will be collected in an Excel document and the patients will be coded.
Identification possibility is limited to the identification of eligible subjects. After that
the subjects will be coded and not possible to identify except with the coding list. The
coding list will be kept by the primary investigator in a secure, IT-protected server within
the Region Skåne. Data analysis and handling will be performed by the investigators on a
material not possible to identify individuals in. The results will be presented in a group
level without possibility to identify individuals.
Statistical analysis The sample constitutes of a total inclusion from a cohort limited in
time, department and treatment method. The project is designed as an observational trial
without a group for comparison. Thus, a power-analysis has not been possible to perform,
neither is it valued necessary for this project.
Simple statistical analysis including mean, standard deviation and range will be used.
The limit for statistical significance will be set to p<0.05. A two-sided p-value will be
used.
