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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.