Registry for patients with mandibular defects after cancer treatment
A Prospective, International, Multicenter Registry of Patients Undergoing Segmental Mandibular Defects Reconstruction (SMDR) After Mandibular Resection for Tumors and Drugs-induced Osteonecrosis
This study is collecting information from patients who have had part of their jaw removed due to cancer to see how different treatments affect their recovery and quality of life over two years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | AO Innovation Translation Center Academic / other |
| Locations | 19 sites (Jacksonville, Florida and 18 other locations) |
| Trial ID | NCT04098146 on ClinicalTrials.gov |
What this trial studies
This observational study aims to collect data from at least 300 patients who have acquired segmental mandibular defects of 2 cm or larger due to the removal of oral tumors or drug-induced osteonecrosis. Participants will undergo standard care follow-ups at various intervals up to 24 months post-surgery. The study will gather comprehensive data on tumor characteristics, neurological function, patient-reported outcomes, and potential adverse events related to the reconstruction procedures. Statistical analyses will be performed to explore relationships between treatment modalities and their outcomes.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with segmental mandibular defects due to oral tumors or drug-induced osteonecrosis requiring reconstruction.
Not a fit: Patients with non-mandibular defects or those not requiring surgical reconstruction will likely not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve understanding of outcomes and complications in patients undergoing mandibular reconstruction, leading to better treatment strategies.
How similar studies have performed: While similar studies have been conducted, this registry approach to specifically track outcomes in mandibular reconstruction following cancer treatment is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Jacksonville, Florida and 18 other locations
- University of Florida College of Medicine — Jacksonville, Florida, United States (Recruiting)
- University of Illinois Chicago — Chicago, Illinois, United States (Recruiting)
- Northwell Health Cancer Institute — New Hyde Park, New York, United States (Not_yet_recruiting)
- Mount Sinai Hospital — New York, New York, United States (Recruiting)
- John Peter Smith Health Network — Fort Worth, Texas, United States (Recruiting)
- Universitätsklinikum Tübingen — Tübingen, Baden-Wurttemberg, Germany (Recruiting)
- University Hospital RWTH Aachen — Aachen, Germany (Recruiting)
- University Hospital Charité — Berlin, Germany (Recruiting)
- Hannover Medical School — Hanover, Germany (Recruiting)
- Universitätsklinikum Heidelberg — Heidelberg, Germany (Recruiting)
- University Hospital Leipzig — Leipzig, Germany (Recruiting)
- Klinikum der LMU München — Munich, Germany (Recruiting)
- University Hospital Ulm — Ulm, Germany (Recruiting)
- Shimane University — Izumo, Japan (Not_yet_recruiting)
- Erasmus University Medical Centre — Rotterdam, Netherlands (Recruiting)
- Luz Hospital — Lisbon, Portugal (Not_yet_recruiting)
- 12 de Octubre — Madrid, Spain (Recruiting)
- Uppsala University Hospital — Uppsala, Sweden (Recruiting)
- University Hospital Basel — Basel, Switzerland (Recruiting)
Study contacts
- Principal investigator: Rüdiger Zimmerer, PD, MD — University of Leipzig
- Study coordinator: Maria Medina Giner
- Email: maria.medinaginer@aofoundation.org
- Phone: 0795456120
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.