Registry to Collect Data on Patients Undergoing Segmental Mandibular Defect Reconstruction Following Oral Squamous Cell Carcinoma Resection and Drugs-induced Osteonecrosis
Recruiting now
Conditions studied: Mandibular Reconstruction, Segmental Mandibular Defects
In brief
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.
Key facts
- Study ID
- NCT04098146
- Run by
- AO Innovation Translation Center
- People needed
- 300
- Starts
- 2022-09-12
- Expected to finish
- 2030-12-31
- Last updated by the study team
- 2025-09-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
- Intraoperative exclusion criteria:
- Nonsegmental mandibular defect (eg. box resection/partial resection)
- Segmental mandibular defect of less than 2 cm
- Mandibular defects extending beyond the sigmoid notch into the condyles
- Additional exclusion criterion:
- No osseous reconstruction with autologous bone performed within 18 months from resection
Where it is running
- University Hospital Basel — Basel, Switzerland (enrolling)
- University of Illinois Chicago — Chicago, Illinois, United States (enrolling)
- 12 de Octubre — Madrid, Spain (enrolling)
- Uppsala University Hospital — Uppsala, Sweden (enrolling)
- University of Florida College of Medicine — Jacksonville, Florida, United States (enrolling)
- Mount Sinai Hospital — New York, New York, United States (enrolling)
- John Peter Smith Health Network — Fort Worth, Texas, United States (enrolling)
- Universitätsklinikum Tübingen — Tübingen, Baden-Wurttemberg, Germany (enrolling)
- University Hospital RWTH Aachen — Aachen, Germany (enrolling)
- University Hospital Charité — Berlin, Germany (enrolling)
- Hannover Medical School — Hanover, Germany (enrolling)
- Universitätsklinikum Heidelberg — Heidelberg, Germany (enrolling)
- University Hospital Leipzig — Leipzig, Germany (enrolling)
- Klinikum der LMU München — Munich, Germany (enrolling)
- University Hospital Ulm — Ulm, Germany (enrolling)
- Erasmus University Medical Centre — Rotterdam, Netherlands (enrolling)
- Northwell Health Cancer Institute — New Hyde Park, New York, United States
- Shimane University — Izumo, Japan
- Luz Hospital — Lisbon, Portugal
Full record on ClinicalTrials.gov
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