Registry to Collect Data on Patients Undergoing Segmental Mandibular Defect Reconstruction Following Oral Squamous Cell Carcinoma Resection and Drugs-induced Osteonecrosis

Launched by AO INNOVATION TRANSLATION CENTER · Sep 18, 2019

Keywords

ClinConnect Summary

This clinical trial is studying how to help patients who need to reconstruct their jaw after having surgery for oral squamous cell carcinoma, a type of cancer that affects the mouth. The researchers are collecting information from at least 300 patients who have a specific type of jaw defect that is 4 centimeters or larger, which occurs after the cancer is removed. The goal is to learn more about the best ways to perform jaw reconstruction using the patient’s own bone.

To be eligible for this study, participants must be at least 18 years old and have been diagnosed with oral squamous cell carcinoma that requires a significant portion of the jaw to be removed. They should plan to undergo reconstruction using their own bone, either in one surgery or in two stages. Participants will need to provide consent to join the study, meaning they understand what the study involves and agree to participate. This trial is currently recruiting participants, and it is important to note that certain patients, such as those with extensive previous jaw surgeries or other active cancers, may not qualify. Participants can expect to contribute to important research that may improve treatment for future patients facing similar challenges.

Gender

ALL

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