RecruitingNCT04098146

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

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

Sponsor

AO Innovation Translation Center

Enrollment

300 participants

Start Date

Sep 12, 2022

Study Type

OBSERVATIONAL

Conditions

Mandibular Reconstruction Segmental Mandibular Defects

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This registry collects data from patients who need part of their jawbone (mandible) removed due to cancer, drug-related bone damage, or other conditions, and who then undergo reconstruction using their own bone from another part of their body. Researchers want to track how well these reconstructions work over time. **You may be eligible if...** - You are 18 or older - You have a cancer, bone damage (from bisphosphonate or other drugs), or another condition requiring removal of at least 2 cm of your jawbone - You are planned to have jawbone reconstruction using your own bone (autologous) **You may NOT be eligible if...** - The tumor involves the jaw joint (condyle) - You are receiving palliative care only - You have had major jaw surgery or reconstruction previously that might affect the study results Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURESurgical Resection and Reconstruction

One stage reconstruction: Osseous reconstruction is performed in the same surgery of the tumor/mandibular resection. It is also known as immediate or primary reconstruction. Second stage reconstruction: Osseous reconstruction is performed after the tumor/mandibular resection surgery as an independent surgery. After the mandibular resection a temporary alloplastic bridging might be put in place. It is also known as delayed or secondary reconstruction.

Locations(19)

University of Florida College of Medicine

Jacksonville, Florida, United States

University of Illinois Chicago

Chicago, Illinois, United States

Northwell Health Cancer Institute

New Hyde Park, New York, United States

Mount Sinai Hospital

New York, New York, United States

John Peter Smith Health Network

Fort Worth, Texas, United States

Universitätsklinikum Tübingen

Tübingen, Baden-Wurttemberg, Germany

University Hospital RWTH Aachen

Aachen, Germany

University Hospital Charité

Berlin, Germany

Hannover Medical School

Hanover, Germany

Universitätsklinikum Heidelberg

Heidelberg, Germany

University Hospital Leipzig

Leipzig, Germany

Klinikum der LMU München

Munich, Germany

University Hospital Ulm

Ulm, Germany

Shimane University

Izumo, Japan

Erasmus University Medical Centre

Rotterdam, Netherlands

Luz Hospital

Lisbon, Portugal

12 de Octubre

Madrid, Spain

Uppsala University Hospital

Uppsala, Sweden

University Hospital Basel

Basel, Switzerland

View Full Details on ClinicalTrials.gov

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NCT04098146

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