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

RecruitingObservational study

A Prospective, International, Multicenter Registry of Patients Undergoing Segmental Mandibular Defects Reconstruction (SMDR) After Mandibular Resection for Tumors and Drugs-induced Osteonecrosis

Who can join

Ages 18 and older · All sexes

Full 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

About the study

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.

What is being tested

Sponsor: AO Innovation Translation Center · Participants: 300 · Started: Sep 12, 2022

Contact the study team

Official record on ClinicalTrials.gov — NCT04098146

Locations in the U.S.

FloridaUniversity of Florida College of Medicine, Jacksonville
IllinoisUniversity of Illinois Chicago, Chicago
New YorkNorthwell Health Cancer Institute, New Hyde Park (Not yet recruiting)
Mount Sinai Hospital, New York
TexasJohn Peter Smith Health Network, Fort Worth

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.