The aim is to provide enough evidence through RifRam model analysis, physical tests and clinical study of 10 patients that our new type of personalized mandibular implant is safe to use, resulting in significantly fewer complications and can be…
ID
Source
Brief title
Condition
- Miscellaneous and site unspecified neoplasms malignant and unspecified
- Head and neck therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The study endpoint is to use the RIfRaM without any complications and a perfect
mandibular fit.
Secondary outcome
Opinions of the surgeons using the implant will be collected in a
non-structured form.
Background summary
This study concerns patients with oral cancer which also includes the mandible,
a part of the mandible should therefor be resected i.e. segmental
mandibulectomy. Because of the central role of the mandible in essential
functions such as mastication, swallowing, speaking, as well as the aesthetic
definition of the face, it must be reconstructed. The standard reconstruction
is usually a free bone flap such as a free fibula or iliac crest flap, and a
medically competent titanium plate is used to connect the bony segments. Some
~40% of the patients are ineligible for such delicate, toilsome operation due
to the conditions of their lower leg and neck vasculature, chronic diseases,
and or general health. These patients only receive a titanium plate instead of
and a local/regional flap to bridge the defect. In time, it was discovered that
these titanium plates were loosening as a result of radio-osteonecrosis,
infections, and having a tendency to bend or break. A recent review of our own
records show that these complications occur in ~40% of the cases leading to
loss of the reconstruction plate. Therefore leading to secondary repair
surgery. In order to solve this difficulty, the clinical expertise of AVL-NKI
and Mobius 3D Technologies joined forces to develop the RIfRaM. RIfRaM is a
patient specifically designed light-weighted 3D printed titanium implant for
those who are not eligible for mandibular reconstruction with fibula bone free
flaps. It has been designed as a light implant that can bear the mastication
force while conserving the patient-specific aesthetic contouring. RIfRaM usage
is aimed to avert the complications of conventional implants such as breaking
and loosening and therefore giving the patient of the long lasting benefit of
the treatment.
Study objective
The aim is to provide enough evidence through RifRam model analysis, physical
tests and clinical study of 10 patients that our new type of personalized
mandibular implant is safe to use, resulting in significantly fewer
complications and can be practically placed during the surgery, without any
complications.
Study design
A non-randomized, prospective clinical feasibility study.
Study burden and risks
Since 3D printed medical-grade titanium medical implants are already being used
at the AvL, there should be no additional risks to the patient other than the
risks involved with the standard procedure of using titanium plates.
Conventional plates are still available for use in case the innovative RifRam
implant appears be not feasible during surgery.
Plesmanlaan 121
Amsterdam 1066 CX
NL
Plesmanlaan 121
Amsterdam 1066 CX
NL
Listed location countries
Age
Inclusion criteria
• Age >= 18 years at time of study entry.
• T4 oral cavity tumor with mandible invasion, requiring segmental
mandibulectomy.
• Reconstruction with free fibula flap not feasible because of any or a
combination of the following reasons::
o CT angiography of the legs and/or the neck shows severe stenosis of the
ves-sels.
o Previous medical history of severe atherosclerotic disease.
o General health condition necessitating a shorter operation time.
• Cases will be discussed in the multidisciplinary tumor board that they are
eligible for composite resection but not eligible for free fibula flap.
• Written informed consent.
Exclusion criteria
• Patients who are eligible for free fibula flap.
• Pregnancy.
• General health condition does not allow surgery
• History of psychiatric disability judged by the investigator to potentially
hamper compliance with the study protocol and follow-up schedule.
• Any psychological, familial, sociological or geographical condition
potentially hampering compliance with the study protocol and follow-up
schedule.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL74131.031.20 |