Clinical trial NCT04098146: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Mandibular Reconstruction
Segmental Mandibular Defects
Keywords: Mandibular osteotomy
Free bone flap
Reconstructive surgical procedure
Adjuvant Irradiation / Chemotherapy
Lead sponsor: AO Innovation Translation Center
Sponsor class: OTHER
First posted: 2019-09-23
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients presenting with an acquired segmental mandibular defect secondary to oral squamous cell carcinoma removal and who require mandibular reconstruction.

Brief 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.

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.

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

Primary outcomes:
measure: Demographics
timeFrame: Baseline until resection surgery approximately 4 weeks
measure: Comorbidities
timeFrame: Baseline until resection surgery approximately 4 weeks
measure: Nicotine consumption
timeFrame: Baseline until resection surgery approximately 4 weeks
measure: Patient reported outcome: Oral Health Impact Profile (OHIP)
timeFrame: Baseline/ 3months/ 6 months/ 12 months/ 18 months/ 24 months
measure: Difference of tumor locations of the oral squamous cell cancer
timeFrame: Baseline until resection surgery ( approximately 4 weeks)
measure: Difference of tumor staging according to the TNM system
timeFrame: Baseline until resection surgery ( approximately 4 weeks)
measure: Difference of surgical duration and hospital stay if resection and reconstruction was performed in one or two stages
timeFrame: Day of resection surgery until day of reconstruction surgery up to 18 months
measure: Difference of surgical procedures of osseous reconstruction
timeFrame: Day of resection surgery until day of reconstruction surgery up to 18 months
measure: Different surgical parameters of tumor and segmental mandibular resection if VSP planning was used
timeFrame: Day of resection surgery until day of reconstruction surgery up to 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: University of Florida College of Medicine
state: Florida
city: Chicago
country: United States
facility: University of Illinois Chicago
state: Illinois
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
city: Fort Worth
country: United States
facility: John Peter Smith Health Network
state: Texas
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen
state: Baden-Württemberg
city: Aachen
country: Germany
facility: University Hospital RWTH Aachen
city: Berlin
country: Germany
facility: University Hospital Charité
city: Hannover
country: Germany
facility: Hannover Medical School
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg
city: Leipzig
country: Germany
facility: University Hospital Leipzig
city: Munich
country: Germany
facility: Klinikum der LMU München
city: Rotterdam
country: Netherlands
facility: Erasmus University Medical Centre
city: Madrid
country: Spain
facility: 12 de Octubre
city: Uppsala
country: Sweden
facility: Uppsala University Hospital
city: Basel
country: Switzerland
facility: University Hospital Basel
Study officials:
affiliation: University of Leipzig
name: Rüdiger Zimmerer, PD, MD
role: PRINCIPAL_INVESTIGATOR
References: