NCT04098146 Registry to Collect Data on Patients Undergoing Segmental Mandibular Defect Reconstruction Following Oral Squamous Cell Carcinoma Resection and Drugs-induced Osteonecrosis
| NCT ID | NCT04098146 |
| Status | Recruiting |
| Phase | — |
| Sponsor | AO Innovation Translation Center |
| Condition | Mandibular Reconstruction |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2022-09-12 |
| Primary Completion | 2030-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 300 participants in total. It began in 2022-09-12 with a primary completion date of 2030-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 mandibular reconstruction.
Eligibility Criteria
Inclusion 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 Exclusion Criteria: * 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
Contact & Investigator
Rüdiger Zimmerer, PD, MD
PRINCIPAL INVESTIGATOR
University of Leipzig
Frequently Asked Questions
Who can join the NCT04098146 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Mandibular Reconstruction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04098146 currently recruiting?
Yes, NCT04098146 is actively recruiting participants. Contact the research team at maria.medinaginer@aofoundation.org for enrollment information.
Where is the NCT04098146 trial being conducted?
This trial is being conducted at Jacksonville, United States, Chicago, United States, New Hyde Park, United States, New York, United States and 11 additional locations.
Who is sponsoring the NCT04098146 clinical trial?
NCT04098146 is sponsored by AO Innovation Translation Center. The principal investigator is Rüdiger Zimmerer, PD, MD at University of Leipzig. The trial plans to enroll 300 participants.