Status:
RECRUITING
Registry to Collect Data on Patients Undergoing Segmental Mandibular Defect Reconstruction Following Oral Squamous Cell Carcinoma Resection and Drugs-induced Osteonecrosis
Lead Sponsor:
AO Innovation Translation Center
Conditions:
Mandibular Reconstruction
Segmental Mandibular Defects
Eligibility:
All Genders
18+ years
Brief 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 man...
Detailed Description
Data will be prospectively collected from at least 300 patients with acquired segmental mandibular defects of 2 cm or larger following resection of tumors or necrotic/infected tissue, all of whom requ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
September 12 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2030
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT04098146
Start Date
September 12 2022
End Date
December 31 2030
Last Update
September 4 2025
Active Locations (19)
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1
University of Florida College of Medicine
Jacksonville, Florida, United States, 32209
2
University of Illinois Chicago
Chicago, Illinois, United States, 60612
3
Northwell Health Cancer Institute
New Hyde Park, New York, United States, 11042
4
Mount Sinai Hospital
New York, New York, United States, 10029