NCT04098146Recruiting
Registry to Collect Data on Patients Undergoing Segmental Mandibular Defect Reconstruction Following Oral Squamous Cell Carcinoma Resection and Drugs-induced Osteonecrosis
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
Contacts
The trial team's contact details are shown on request.
See the official trial record- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Countries
- Switzerland, Germany, United States, Japan, Netherlands, Portugal, Spain, Sweden
- Sponsor
- AO Innovation Translation Center(Other)
- Protocol no.
- SMDR Registry
- Conditions
- Mandibular Reconstruction, Segmental Mandibular Defects
- Interventions
- Procedure
Treatments studied
- Surgical Resection and Reconstruction
Locations · 16
- Basel, SwitzerlandUniversity Hospital BaselRecruiting at this site
- Tübingen, GermanyUniversitätsklinikum TübingenRecruiting at this site
- Aachen, GermanyUniversity Hospital RWTH AachenRecruiting at this site
- Berlin, GermanyUniversity Hospital CharitéRecruiting at this site
- Hanover, GermanyHannover Medical SchoolRecruiting at this site
- Heidelberg, GermanyUniversitätsklinikum HeidelbergRecruiting at this site
- Leipzig, GermanyUniversity Hospital LeipzigRecruiting at this site
- Munich, GermanyKlinikum der LMU MünchenRecruiting at this site
- Ulm, GermanyUniversity Hospital UlmRecruiting at this site
- Jacksonville, United StatesUniversity of Florida College of MedicineRecruiting at this site
- Chicago, United StatesUniversity of Illinois ChicagoRecruiting at this site
- New York, United StatesMount Sinai HospitalRecruiting at this site
- Fort Worth, United StatesJohn Peter Smith Health NetworkRecruiting at this site
- Rotterdam, NetherlandsErasmus University Medical CentreRecruiting at this site
- Madrid, Spain12 de OctubreRecruiting at this site
- Uppsala, SwedenUppsala University HospitalRecruiting at this site
In total, worldwide, 16 of the 19 sites listed in the registry are recruiting; the other 3 are not currently recruiting.
Site status per the ClinicalTrials.gov registry (last update posted: September 4, 2025).
This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.
See also
Other versions
These results are indicative and do not replace medical advice — discuss them with your doctor.