RECRUITING

Registry to Collect Data on Patients Undergoing Segmental Mandibular Defect Reconstruction Following Oral Squamous Cell Carcinoma Resection and Drugs-induced Osteonecrosis

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Conditions

Mandibular ReconstructionSegmental Mandibular DefectsMandibular osteotomyFree bone flapReconstructive surgical procedureAdjuvant Irradiation / Chemotherapy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Prospective will be collected in a minimum of 300 patients presenting with an acquired segmental mandibular defect ≥ 2 cm secondary to OSSC removal and drugs-induced osteonecrosis, and who require mandibular reconstruction.

Official Title

A Prospective, International, Multicenter Registry of Patients Undergoing Segmental Mandibular Defects Reconstruction (SMDR) After Mandibular Resection for Tumors and Drugs-induced Osteonecrosis

Quick Facts

Study Start:2022-09-12
Study Completion:2030-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04098146

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Not specified
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * The study includes patients with an initial pathological/histologic diagnosis of mandibular involvement by oral tumors (such as OSCC, osteosarcoma, and ameloblastoma), bisphosphonate- or immunomodulatory drug-induced osteonecrosis, and mandibular lesions from metastatic conditions originating from other sites including lung, breast, prostate, or kidney.
  2. * Age 18 years and older
  3. * Bisphosphonate related osteonecrosis of the mandible
  4. * Immunomodulatory drugs induced mandibular osteonecrosis
  5. * Patients presented with ameloblastoma affecting the mandible
  6. * Patients presented with osteosarcomas of the mandible
  7. * Patients presented with oral metastases related mandibular lesions that are indicated for segmental resection, common primary tumor sites include lung, breast, prostate and kidney
  8. * Undergoing primary curative treatment with segmental resection of the mandible ≥2 cm
  9. * Intention to undergo mandibular reconstruction with autologous bone using a primary (one-stage) or secondary (two-stage) approach
  10. * Informed consent obtained, ie:
  11. * Ability to understand the content of the patient information/ICF
  12. * Willingness and ability to participate in the clinical investigation according to the registry plan (RP) o Signed and dated IRB/EC approved ICF OR
  13. * Written consent provided according to the IRB/EC defined and approved procedures for patients who are not able to provide to provide independent written informed consent
  1. * Tumors affecting the condyle
  2. * Patients under palliative care
  3. * Previous extensive mandibular surgeries (including reconstructions, e.g., TMJ replacement) that may potentially confound the outcome measures

Contacts and Locations

Study Contact

Maria Medina Giner
CONTACT
0795456120
maria.medinaginer@aofoundation.org
Marco Minoia, PhD
CONTACT
marco.minoia@aofoundation.org

Principal Investigator

Rüdiger Zimmerer, PD, MD
PRINCIPAL_INVESTIGATOR
University of Leipzig

Study Locations (Sites)

University of Florida College of Medicine
Jacksonville, Florida, 32209
United States
University of Illinois Chicago
Chicago, Illinois, 60612
United States
Mount Sinai Hospital
New York, New York, 10029
United States
John Peter Smith Health Network
Fort Worth, Texas, 76104
United States

Collaborators and Investigators

Sponsor: AO Innovation Translation Center

  • Rüdiger Zimmerer, PD, MD, PRINCIPAL_INVESTIGATOR, University of Leipzig

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-09-12
Study Completion Date2030-12-31

Study Record Updates

Study Start Date2022-09-12
Study Completion Date2030-12-31

Terms related to this study

Keywords Provided by Researchers

  • Mandibular osteotomy
  • Free bone flap
  • Reconstructive surgical procedure
  • Adjuvant Irradiation / Chemotherapy

Additional Relevant MeSH Terms

  • Mandibular Reconstruction
  • Segmental Mandibular Defects