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

NCT04098146 | Recruiting

• 1 other identifier: SMDR Registry
• Study Type: observational
• Target: 300
• Locations: 8 countries
• Sites: 19

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.

Conditions

Mandibular Reconstruction; Segmental Mandibular Defects

Keywords

Mandibular osteotomy; Free bone flap; Reconstructive surgical procedure; Adjuvant Irradiation / Chemotherapy

Outcome Measures

Primary Outcomes (9)

• Demographics

  Demographics (year of birth, height in cm and weight in kilogram, race)

  Baseline until resection surgery approximately 4 weeks

• 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

• 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

• 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

• 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)

• 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)

• 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

• 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

• 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

Study Arms (1)

Mandibular Reconstruction

Patients undergoing segmental mandibular defect reconstruction. The decision of one stage or two stage reconstruction is done according to the patient and treating surgeon preferences following the local standard of care

Procedure: Surgical Resection and Reconstruction

Interventions

Surgical Resection and Reconstruction PROCEDURE

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.

Mandibular Reconstruction

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• No osseous reconstruction with autologous bone performed within 18 months from resection

Sponsors & Collaborators

• AO Innovation Translation Center: lead

Study Sites (19)

University of Florida College of Medicine

Jacksonville, Florida, 32209, United States

RECRUITING

University of Illinois Chicago

Chicago, Illinois, 60612, United States

RECRUITING

Northwell Health Cancer Institute

New Hyde Park, New York, 11042, United States

NOT YET RECRUITING

Mount Sinai Hospital

New York, New York, 10029, United States

RECRUITING

John Peter Smith Health Network

Fort Worth, Texas, 76104, United States

RECRUITING

Universitätsklinikum Tübingen

Tübingen, Baden-Wurttemberg, 72076, Germany

RECRUITING

University Hospital RWTH Aachen

Aachen, 52074, Germany

RECRUITING

University Hospital Charité

Berlin, 13353, Germany

RECRUITING

Hannover Medical School

Hanover, 30625, Germany

RECRUITING

Universitätsklinikum Heidelberg

Heidelberg, 69120, Germany

RECRUITING

University Hospital Leipzig

Leipzig, 04103, Germany

RECRUITING

Klinikum der LMU München

Munich, 80337, Germany

RECRUITING

University Hospital Ulm

Ulm, 89081, Germany

RECRUITING

Shimane University

Izumo, 693-0001, Japan

NOT YET RECRUITING

Erasmus University Medical Centre

Rotterdam, 3015 GD, Netherlands

RECRUITING

Luz Hospital

Lisbon, 1500-650, Portugal

NOT YET RECRUITING

12 de Octubre

Madrid, 28041, Spain

RECRUITING

Uppsala University Hospital

Uppsala, 75185, Sweden

RECRUITING

University Hospital Basel

Basel, 4031, Switzerland

RECRUITING

MeSH Terms

Interventions

Plastic Surgery Procedures

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

• Rüdiger Zimmerer, PD, MD

  University of Leipzig

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Medina Giner

CONTACT

0795456120; maria.medinaginer@aofoundation.org

Marco Minoia, PhD

CONTACT

marco.minoia@aofoundation.org

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2019
• First Posted: September 23, 2019
• Study Start: September 12, 2022
• Primary Completion (Estimated): June 30, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: September 4, 2025

Record last verified: 2025-08

Locations

ES (1); US (5); JP (1); CH (1); PT (1); NL (1); SE (1); DE (8)