Mandibular Reconstruction Clinical Trial
Official title:
International, Multicenter, Prospective Registry to Collect Data on Patients Undergoing Segmental Mandibular Defect Reconstruction (SMDR) Following Oral Squamous Cell Carcinoma (OSSC) Resection
Prospective will be collected in a minimum of 300 patients presenting with an acquired segmental mandibular defect ≥ 4 cm secondary to OSSC removal and who require mandibular reconstruction.
Status | Recruiting |
Enrollment | 300 |
Est. completion date | December 31, 2028 |
Est. primary completion date | January 31, 2027 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age 18 years and older - Initial pathologically confirmed diagnosis of primary oral squamous cell carcinoma located in mucosa and/or mandible - Undergoing primary curative treatment with segmental resection of the mandible =4 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) - Signed and dated IRB/EC approved informed consent (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 - Distant OSCC metastasis - Any other active concomitant malignancy within the last 5 years - Patients who require neoadjuvant therapy - Patients under palliative care - Previous extensive mandibular surgeries (including reconstructions) Intraoperative exclusion criteria: - Nonsegmental mandibular defect (eg. box resection/partial resection) - Segmental mandibular defect of less than 4 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 |
Country | Name | City | State |
---|---|---|---|
Germany | University Hospital RWTH Aachen | Aachen | |
Germany | University Hospital Charité | Berlin | |
Germany | Hannover Medical School | Hannover | |
Germany | Universitätsklinikum Heidelberg | Heidelberg | |
Germany | University Hospital Leipzig | Leipzig | |
Germany | Klinikum der LMU München | Munich | |
Germany | Universitätsklinikum Tübingen | Tübingen | Baden-Württemberg |
Netherlands | Erasmus University Medical Centre | Rotterdam | |
Spain | 12 de Octubre | Madrid | |
Sweden | Uppsala University Hospital | Uppsala | |
Switzerland | University Hospital Basel | Basel | |
United States | John Peter Smith Health Network | Fort Worth | Texas |
United States | University of Florida College of Medicine | Jacksonville | Florida |
Lead Sponsor | Collaborator |
---|---|
AO Innovation Translation Center |
United States, Germany, Netherlands, Spain, Sweden, Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Demographics | Demographics (year of birth, height in cm and weight in kilogram, race) | Baseline until resection surgery approximately 4 weeks | |
Primary | Comorbidities | Comorbidities assessed by Charlson Comorbidity Index (this score assesses the comorbidity level by considering both the number and severity of predefined comorbidity conditions. It provides a weighted score of a patient's comorbidities which can be used to predict mortality rates | Baseline until resection surgery approximately 4 weeks | |
Primary | Nicotine consumption | Current and previous nicotine use will be collected:
Number of years Time (years) since stopped using (if applicable) Amount of cigarettes/day |
Baseline until resection surgery approximately 4 weeks | |
Primary | Patient reported outcome: Oral Health Impact Profile (OHIP) | Change in the OHIP over the follow-up period.
The Oral Health Impact Profile is providing a comprehensive measure of self-reported dysfunction, discomfort and disability attributed to oral conditions. The OHIP is concerned with impairment and three functional status dimensions (social, psychological, and physical). Respondents are asked to indicate on a five-point Likert scale how frequently they experienced each problem. Response categories for the five-point scale are: "Very often", "Fairly often", "Occasionally", "Hardly ever" and "Never". The OHIP consists of 14 questions in which higher scores indicate worse outcomes. |
Baseline/ 3months/ 6 months/ 12 months/ 18 months/ 24 months | |
Primary | Difference of tumor locations of the oral squamous cell cancer | Oral squamous cell carcinoma locations acoording to follwoing regions:
Anterior compartment which includes lower lip, buccal mucosa, anterior vestibule, anterior ridge and anterior floor mouth Lateral compartment which includes posterior vestibule, posterior alveolar ridge, posterior (lateral) floor of mouth Retromolar compartment which includes alveolar ridge posterior to last molar, region of wisdom teeth, retromolar triangle ie buccal cheek, soft palate (arch), tonsillar regions Tongue which includes ventral tongue (undersurface of tongue), lateral rim of tongue, base of tongue |
Baseline until resection surgery ( approximately 4 weeks) | |
Primary | Difference of tumor staging according to the TNM system | Oral squamous cell carcinoma staging according to TNM (Tumor, Node, Metastasis) system.
In the TNM system the "T" refers to the size and extent of the main tumor likert from T0 to T4 whereas T0 is the smallest and T4 the biggest size. The main tumor is usually called the primary tumor. The "N" refers to the number of nearby lymph nodes that have cancer likert for N0 to N3 whereas N0 is the single nearby lymphnode and N3 multiple lymphnodes. The "M" refers to whether the cancer has metastasized likert from M0 to M1 whereas M0 is no distant metastasis and M1 is distant metastasis. |
Baseline until resection surgery ( approximately 4 weeks) | |
Primary | Difference of surgical duration and hospital stay if resection and reconstruction was performed in one or two stages | Duration of surgery (skin to skin) in minutes
Length of hospital stay in days Date of osseous reconstruction (if different from resection surgery) in days |
Day of resection surgery until day of reconstruction surgery up to 18 months | |
Primary | Difference of surgical procedures of osseous reconstruction | Numers of Bone and soft tissue flaps to reconstruct the mandible: ie number of pieces in which the donor bone(s) is cut to shape the reconstructed mandible
Type of bone donor/ bone transfer site(s): Vascularized bone flap(s) or composite flaps (ie bone and adjacent soft tissue harvested within the same flap) and type(s) |
Day of resection surgery until day of reconstruction surgery up to 18 months | |
Primary | Different surgical parameters of tumor and segmental mandibular resection if VSP planning was used | Use of virtual surgical planning (VSP) for resection: Yes/No.
Only virtual planning and simulation of resection (no 3D printing):Yes/No. 3D-printed biomodels: Yes/No |
Day of resection surgery until day of reconstruction surgery up to 18 months |
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