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Compares treatment options for Significant Bone Defect in the Orbit
Official title Efficiency of 3D-printed Implant Versus Autograft for Orbital Reconstruction (TOR-3D)
ClinicalTrials.gov ID: NCT03608280
What this study is testing
- What it's testing
- Two scenarios may result in significant bone defect in the orbit: surgical oncology (meningioma, cancers of the upper aerodigestive tract) or severe trauma. This defect in the bone substance may affect the orbital floor, medial wall or lateral wall.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 90
You may be able to join if
- Patient between 18 to 90 years old
- Presenting a defect in the bone substance of an orbital wall (floor, lateral or medial): at least 6 months following a oncologic surgery (in...
- With a defect of the unilateral orbital bone substance described as complex on the CT-scan: fracture in the posterior third of one walls; fracture...
- Presenting an enophthalmos ≥ 3 mm OR an enophthalmos ≥ 2mm with diplopia;
- Patient with a programmed orbital reconstruction;
You likely can't join if
- Defect of bone substance extended to the upper and / or intermediate floors of the skull-base;
- For patients who have undergone oncologic surgery, patients with uncontrolled cancer proliferation;
- Defect of bone substance from the skull vault;
- Osteo-meningeal Breach;
- Patient whose understand the French questionnaire EQ-5D-3L;
- Follow up not possible during 18months (judgement of investigator)
See the full eligibility criteria
- Patient between 18 to 90 years old
- Presenting a defect in the bone substance of an orbital wall (floor, lateral or medial): at least 6 months following a oncologic surgery (in particular meningioma or carcinoma of the upper aerodigestive tract) OR...
- With a defect of the unilateral orbital bone substance described as complex on the CT-scan: fracture in the posterior third of one walls; fracture extended to two walls (floor and lateral wall, or medial wall and...
- Presenting an enophthalmos ≥ 3 mm OR an enophthalmos ≥ 2mm with diplopia;
- Patient with a programmed orbital reconstruction;
- For patients who have had oncologic surgery, validation of a multidisciplinary consultation meeting;
- Whose contralateral orbital anatomy is healthy (absence of : bone defect, diplopia, ptosis or other condition affecting aesthetics);
- Patient who gave its written informed consent to participate to the study;
- Affiliated to a social insurgence regime or similar.
- Defect of bone substance extended to the upper and / or intermediate floors of the skull-base;
- For patients who have undergone oncologic surgery, patients with uncontrolled cancer proliferation;
- Defect of bone substance from the skull vault;
- Osteo-meningeal Breach;
- Patient whose understand the French questionnaire EQ-5D-3L;
- Follow up not possible during 18months (judgement of investigator)
- Patient with hypersensitivity to metallic materials;
- Major patient protected by the Law;
- Pregnant or breastfeeding woman
The study team makes the final eligibility decision.
Where it's taking place
- Pierre-Bénite, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Pierre-Bénite, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.