Improved Implant for Reconstruction Purposes After Mandibular Resection

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Brief Title

Improved Implant for Reconstruction Purposes After Mandibular Resection

Official Title

Improved Implant for Reconstruction Purposes After Mandibular Resection

Brief Summary

      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.

Detailed Description

      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.

Study Type

Interventional

Primary Outcome

Surgical fit

Condition

Head and Neck Cancer

Intervention

RIFRAM implant

Study Arms / Comparison Groups

 RIFRAM implant
Description:  RIFRAM implant

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Device

Estimated Enrollment

10

Start Date

November 29, 2021

Completion Date

November 29, 2024

Primary Completion Date

November 29, 2023

Eligibility Criteria

        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-sels.

          -  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.

          -  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.

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Baris Karakullukcu, PhD, +31205122550, [email protected]

Location Countries

Netherlands

Location Countries

Netherlands

Administrative Informations

NCT ID

NCT05153733

Organization ID

N19IRM

Secondary IDs

NL74131.031.20

Responsible Party

Sponsor

Study Sponsor

The Netherlands Cancer Institute

Study Sponsor

Baris Karakullukcu, PhD, Principal Investigator, The Netherlands Cancer Institute

Verification Date

December 2021