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

Official title

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

Overview

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.

Detailed description

Data will be prospectively collected from at least 300 patients with acquired segmental mandibular defects of 2 cm or larger following resection of tumors or necrotic/infected tissue, all of whom require mandibular reconstruction.

The follow up (FU) will consist of standard of care (routine) procedures and data collection will be done at 3, 6, 12, 18 and up to 24 months after resection and/or reconstruction. The maximum FU for each patient within the registry will be 2 years after mandibular resection.

Data collection will include confounding baseline data, tumor characteristics, neurological function, patient reported outcomes, quality of life as well as anticipated procedure-related adverse events (AEs). Available images will be collected and evaluated centrally to determine the location, positioning, osseointegration, bone quantity and quality of the transplants.

Depending on the volume and quality of the collected data, different statistical analyses will be performed. Exploratory analyses will be conducted to find relationships between the different treatment modalities and their outcomes.

Interventions

• Procedure Surgical Resection and Reconstruction
  One stage reconstruction: Osseous reconstruction is performed in the same surgery of the tumor/mandibular resection. It is also known as immediate or primary reconstruction. Second stage reconstruction: Osseous reconstruction is performed after the tumor/mandibular resection surgery as an independent surgery. After the mandibular resection a temporary alloplastic bridging might be put in place. It is also known as delayed or secondary reconstruction.

Primary outcome measures

• Demographics [Time frame: Baseline until resection surgery approximately 4 weeks]
• Comorbidities [Time frame: Baseline until resection surgery approximately 4 weeks]
• Nicotine consumption [Time frame: Baseline until resection surgery approximately 4 weeks]
• Patient reported outcome: Oral Health Impact Profile (OHIP) [Time frame: Baseline/ 3months/ 6 months/ 12 months/ 18 months/ 24 months]
• Difference of tumor locations of the oral squamous cell cancer [Time frame: Baseline until resection surgery ( approximately 4 weeks)]
• Difference of tumor staging according to the TNM system [Time frame: Baseline until resection surgery ( approximately 4 weeks)]
• Difference of surgical duration and hospital stay if resection and reconstruction was performed in one or two stages [Time frame: Day of resection surgery until day of reconstruction surgery up to 18 months]
• Difference of surgical procedures of osseous reconstruction [Time frame: Day of resection surgery until day of reconstruction surgery up to 18 months]
• Different surgical parameters of tumor and segmental mandibular resection if VSP planning was used [Time frame: Day of resection surgery until day of reconstruction surgery up to 18 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model

Case-control

Study locations

Germany · 8 centers

• Universitätsklinikum Tübingen — Tübingen
• University Hospital RWTH Aachen — Aachen
• University Hospital Charité — Berlin
• Hannover Medical School — Hanover
• Universitätsklinikum Heidelberg — Heidelberg
• University Hospital Leipzig — Leipzig
• Klinikum der LMU München — Munich
• University Hospital Ulm — Ulm

United States · 5 centers

• University of Florida College of Medicine — Jacksonville
• University of Illinois Chicago — Chicago
• Northwell Health Cancer Institute — New Hyde Park
• Mount Sinai Hospital — New York
• John Peter Smith Health Network — Fort Worth

Japan · 1 center

• Shimane University — Izumo

Netherlands · 1 center

• Erasmus University Medical Centre — Rotterdam

Portugal · 1 center

• Luz Hospital — Lisbon

Spain · 1 center

• 12 de Octubre — Madrid

Sweden · 1 center

• Uppsala University Hospital — Uppsala

Switzerland · 1 center

• University Hospital Basel — Basel

Identifiers

NCT: NCT04098146 · SMDR Registry

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗