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

Status: Recruiting
Location: See all (19) locations...
Intervention Type: Procedure
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
View:

• 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

Locations
United States
Florida
University of Florida College of Medicine
RECRUITING
Jacksonville
Illinois
University of Illinois Chicago
RECRUITING
Chicago
New York
Northwell Health Cancer Institute
NOT_YET_RECRUITING
New Hyde Park
Mount Sinai Hospital
RECRUITING
New York
Texas
John Peter Smith Health Network
RECRUITING
Fort Worth
Other Locations
Germany
University Hospital RWTH Aachen
RECRUITING
Aachen
University Hospital Charité
RECRUITING
Berlin
Hannover Medical School
RECRUITING
Hanover
Universitätsklinikum Heidelberg
RECRUITING
Heidelberg
University Hospital Leipzig
RECRUITING
Leipzig
Klinikum der LMU München
RECRUITING
Munich
Universitätsklinikum Tübingen
RECRUITING
Tübingen
University Hospital Ulm
RECRUITING
Ulm
Japan
Shimane University
NOT_YET_RECRUITING
Izumo
Netherlands
Erasmus University Medical Centre
RECRUITING
Rotterdam
Portugal
Luz Hospital
NOT_YET_RECRUITING
Lisbon
Spain
12 de Octubre
RECRUITING
Madrid
Sweden
Uppsala University Hospital
RECRUITING
Uppsala
Switzerland
University Hospital Basel
RECRUITING
Basel
Contact Information
Primary
Maria Medina Giner
maria.medinaginer@aofoundation.org
0795456120
Backup
Marco Minoia, PhD
marco.minoia@aofoundation.org
Time Frame
Start Date: 2022-09-12
Estimated Completion Date: 2030-12-31
Participants
Target number of participants: 300
Treatments
Mandibular Reconstruction
Patients undergoing segmental mandibular defect reconstruction. The decision of one stage or two stage reconstruction is done according to the patient and treating surgeon preferences following the local standard of care
Related Therapeutic Areas
Sponsors
Leads: AO Innovation Translation Center

This content was sourced from clinicaltrials.gov