Comparing 3D-printed implants to bone grafts for orbital reconstruction

Evaluation of the Efficiency for Orbital Reconstruction After Defect of Bone Substance by Three-dimensional Printed Patient Specific Porous Titanium Implant in Comparison With Autologous Bone Graft

This study is testing if 3D-printed titanium implants can work better than traditional bone grafts for fixing serious bone damage around the eye in patients aged 18 to 90.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 92 (estimated)
• Ages: 18 Years to 90 Years
• Sex: All
• Sponsor: Hospices Civils de Lyon (Academic / other)
• Locations: 1 site (Pierre-Bénite)
• Trial ID: NCT03608280 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of 3D-printed porous titanium implants versus traditional autologous bone grafts for reconstructing significant bone defects in the orbit, which can occur due to surgical oncology or severe trauma. The goal is to restore the orbital volume and shape, addressing complications such as enophthalmos and diplopia that can affect patients' quality of life. Patients aged 18 to 90 with specific orbital bone defects will be included, and the study aims to determine if the titanium implants provide better outcomes than the current gold standard of bone grafts.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 90 with complex unilateral orbital bone defects and associated complications like enophthalmos.

Not a fit: Patients without significant orbital bone defects or those with healthy contralateral orbital anatomy may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved surgical outcomes and quality of life for patients with orbital bone defects.

How similar studies have performed: While the use of 3D-printed implants is a novel approach, similar studies have shown promising results in other areas of reconstructive surgery.

Eligibility criteria

Inclusion 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 post-traumatic;
* 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 orbital floor); comminutive fracture of at least one of the walls; fracture with more than half of one of the walls tipped over;
* 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.

Exclusion Criteria:

* 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

Where this trial is running

Pierre-Bénite

• Hospices Civils de Lyon, Groupement Hospitalier Sud Chirurgie maxillo-faciale — Pierre-Bénite, France (Recruiting)

Study contacts

• Study coordinator: Jean-Thomas BACHELET

Conditions Significant Bone Defect in the Orbit; orbital reconstruction; 3D-printed patient specific porous titanium implant; autologous bone graft; medico-economic study