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
AO Innovation Translation Center
300 participants
Sep 12, 2022
OBSERVATIONAL
Conditions
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
Inclusion Criteria13
- 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 Criteria8
- 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
- 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
Interventions
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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04098146