Improved Implant for Reconstruction Purposes After Mandibular Resection

NCT05153733 | Terminated

• 2 other identifiers: N19IRMNL74131.031.20
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Cancer; Oral Cancer

Keywords

surgery; COMMANDO

Outcome Measures

Primary Outcomes (2)

• Surgical fit

  good fit during surgery, suboptimal fit of the mandible making placement not possible.

  intra-operative

• Complications

  Implant related complications leading to implant loss

  implant loss in 1-year post-operational follow-up.

Study Arms (1)

RIFRAM implant

EXPERIMENTAL

RIFRAM implant

Device: RIFRAM implant

Interventions

RIFRAM implant DEVICE

Participants will receive the newly developed, patient-specific RIfRaM mandibular implant.

Also known as: COMMANDO

RIFRAM implant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Netherlands Cancer Institute: lead

Study Sites (1)

Antoni van Leeuwenhoek

Amsterdam, North Holland, 1082 MK, Netherlands

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Mouth Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Baris Karakullukcu, PhD

  The Netherlands Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2021
• First Posted: December 10, 2021
• Study Start: November 29, 2021
• Primary Completion: March 13, 2024
• Study Completion: March 13, 2024
• Last Updated: July 24, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)