A Prospective, International, Multicenter Registry of Patients Undergoing Segmental Mandibular Defects Reconstruction (SMDR) After Mandibular Resection for Tumors and Drugs-induced Osteonecrosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 19
- 主要终点
- Patient reported outcome: Oral Health Impact Profile (OHIP)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Patient reported outcome: Oral Health Impact Profile (OHIP)
时间窗: Baseline/ 3months/ 6 months/ 12 months/ 18 months/ 24 months
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.
Different surgical parameters of tumor and segmental mandibular resection if VSP planning was used
时间窗: Day of resection surgery until day of reconstruction surgery up to 18 months
* 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
Demographics
时间窗: Baseline until resection surgery approximately 4 weeks
Demographics (year of birth, height in cm and weight in kilogram, race)
Difference of tumor locations of the oral squamous cell cancer
时间窗: Baseline until resection surgery ( approximately 4 weeks)
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
Difference of tumor staging according to the TNM system
时间窗: Baseline until resection surgery ( approximately 4 weeks)
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.
Comorbidities
时间窗: Baseline until resection surgery approximately 4 weeks
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
Nicotine consumption
时间窗: Baseline until resection surgery approximately 4 weeks
Current and previous nicotine use will be collected: * Number of years * Time (years) since stopped using (if applicable) * Amount of cigarettes/day
Difference of surgical duration and hospital stay if resection and reconstruction was performed in one or two stages
时间窗: Day of resection surgery until day of reconstruction surgery up to 18 months
* 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
Difference of surgical procedures of osseous reconstruction
时间窗: Day of resection surgery until day of reconstruction surgery up to 18 months
* 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)
次要结局
未报告次要终点