Improved Implant for Reconstruction Purposes After Mandibular Resection (RifRam)

  • End date
    Nov 29, 2024
  • participants needed
  • sponsor
    The Netherlands Cancer Institute
Updated on 24 March 2022
Accepts healthy volunteers


Study design: A single center non-randomized, prospective clinical feasibility study.

Study population: Study population is composed of 10 patients ineligible for a free-flap bone reconstruction.

Intervention: The selected patients will receive the newly developed, patient-specific RIfRaM mandibular implant.

Objective: The aim is to provide enough evidence through 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.

Main study parameters/endpoints: The study endpoint is to use the RifRaM without any implant related complications and a perfect mandibular fit.


The preoperative bony resection planning and the design of the RifRam implant will be carried out on 3D reconstructed CT image of the mandible. The necessary resection planes will be marked on the 3D model. This segment will be removed virtually and replaced by the designed RifRam implant. The form of the implant will follow the contours of the native healthy mandible. In case, extensive bone destruction of the mandible does not allow copying the contours, contralateral side of the mandible will be virtually mirrored and used to design the implant. The design of the implant will be carried out within the NKI/AVL and the data will be preserved in restricted access folders. The designed implant will be printed with a hollow mesh core by Mobius. A matching cutting guide will be printed as well. Two copies of the implant will be delivered in case one would be accidentally be unsterile (see 5.3). The cutting guides are used to cut the mandible at exactly the intended places. The implant and the cutting guide will be delivered to the hospital and sterilized by Clinium for clinical use.

The patient will undergo a COMMANDO (combined mandibulectomy and neck dissection) procedure. The steps of this procedure are well defined and can be found in iProva. The oncological resection will be carried out in the standard fashion. Mandible saw cutting guides are used as standard procedure. The patient specific mandible cutting guide will be fixed on the mandible and the cuts to the mandible will be made through the cutting slots. This step enables that the mandible defect matches exactly the RifRam implant. After the resection is completed and the surgical site irrigated as per standard procedure, the Rifram implant will be placed to fill the bone defect. The implant will be fixed with 2.7 mm locking screws produced by KLS Martin. These screws are used are used as standard and are available in stock in the operation complex. The soft tissue defect will be reconstructed using a regional flap such as pectoralis major musculocutaneous flap. The rest of the procedure will be completed as per established clinical protocol.

Condition Head and Neck Cancer, Oral Cancer
Treatment RIFRAM implant
Clinical Study IdentifierNCT05153733
SponsorThe Netherlands Cancer Institute
Last Modified on24 March 2022


Yes No Not Sure

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
oCT angiography of the legs and/or the neck shows severe stenosis of the ves-
Previous medical history of severe atherosclerotic disease
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
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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact



Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note