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

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.

Conditions

Mandibular Reconstruction, Segmental Mandibular Defects

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Mandibular Reconstruction
Intervention / Treatment

-

Contacts and Locations

Jacksonville

University of Florida College of Medicine, Jacksonville, Florida, United States, 32209

Chicago

University of Illinois Chicago, Chicago, Illinois, United States, 60612

New York

Mount Sinai Hospital, New York, New York, United States, 10029

Fort Worth

John Peter Smith Health Network, Fort Worth, Texas, United States, 76104

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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.
  • * Age 18 years and older
  • * Bisphosphonate related osteonecrosis of the mandible
  • * Immunomodulatory drugs induced mandibular osteonecrosis
  • * Patients presented with ameloblastoma affecting the mandible
  • * Patients presented with osteosarcomas of the mandible
  • * Patients presented with oral metastases related mandibular lesions that are indicated for segmental resection, common primary tumor sites include lung, breast, prostate and kidney
  • * Undergoing primary curative treatment with segmental resection of the mandible ≥2 cm
  • * Intention to undergo mandibular reconstruction with autologous bone using a primary (one-stage) or secondary (two-stage) approach
  • * Informed consent obtained, ie:
  • * Ability to understand the content of the patient information/ICF
  • * Willingness and ability to participate in the clinical investigation according to the registry plan (RP) o Signed and dated IRB/EC approved ICF OR
  • * 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
  • * Tumors affecting the condyle
  • * Patients under palliative care
  • * Previous extensive mandibular surgeries (including reconstructions, e.g., TMJ replacement) that may potentially confound the outcome measures

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

AO Innovation Translation Center,

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

Study Record Dates

2030-12-31