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Global registry aims to improve jaw reconstruction outcomes

NCT ID NCT04098146

Knowledge-focused Sponsor: AO Innovation Translation Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study is a registry that will follow at least 300 people who need jaw reconstruction after having part of their jaw removed due to cancer or medication-related bone damage. Researchers will collect information on surgical methods, recovery times, and quality of life to learn which approaches work best. The goal is to gather real-world data to guide future treatment decisions.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this registry could help surgeons identify the best reconstruction methods and improve recovery and quality of life for patients with jaw defects.
What could go wrong
This is an observational registry, not a treatment trial, so it won't directly test a new therapy. Results may take years and might not lead to immediate changes in care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2022

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients presenting with an acquired segmental mandibular defect secondary to oral squamous cell carcinoma removal and who require mandibular reconstruction.

Ages

18 years and older

Sex

Anyone

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

ameloblastoma oral cavity squamous cell carcinoma osteonecrosis of the jaw osteosarcoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Mandibular reconstruction Segmental mandibular defects

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    19 sites in 8 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • 12 de Octubre

    RECRUITING

    Madrid, 28041, Spain

  • Erasmus University Medical Centre

    RECRUITING

    Rotterdam, 3015 GD, Netherlands

  • Hannover Medical School

    RECRUITING

    Hanover, 30625, Germany

  • John Peter Smith Health Network

    RECRUITING

    Fort Worth, Texas, 76104, United States

  • Klinikum der LMU München

    RECRUITING

    Munich, 80337, Germany

  • Luz Hospital

    NOT_YET_RECRUITING

    Lisbon, 1500-650, Portugal

  • Mount Sinai Hospital

    RECRUITING

    New York, New York, 10029, United States

  • Northwell Health Cancer Institute

    NOT_YET_RECRUITING

    New Hyde Park, New York, 11042, United States

  • Shimane University

    NOT_YET_RECRUITING

    Izumo, 693-0001, Japan

  • University Hospital Basel

    RECRUITING

    Basel, 4031, Switzerland

  • University Hospital Charité

    RECRUITING

    Berlin, 13353, Germany

  • University Hospital Leipzig

    RECRUITING

    Leipzig, 04103, Germany

  • University Hospital RWTH Aachen

    RECRUITING

    Aachen, 52074, Germany

  • University Hospital Ulm

    RECRUITING

    Ulm, 89081, Germany

  • University of Florida College of Medicine

    RECRUITING

    Jacksonville, Florida, 32209, United States

  • University of Illinois Chicago

    RECRUITING

    Chicago, Illinois, 60612, United States

  • Universitätsklinikum Heidelberg

    RECRUITING

    Heidelberg, 69120, Germany

  • Universitätsklinikum Tübingen

    RECRUITING

    Tübingen, Baden-Wurttemberg, 72076, Germany

  • Uppsala University Hospital

    RECRUITING

    Uppsala, 75185, Sweden

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