Condition: Significant Bone Defect in the Orbit · Sponsor: Hospices Civils de Lyon
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. These injuries can result in functional complications such as enophthalmos and diplopia, and an esthetic impact affecting the quality of life. The most frequent complication in orbital traumas is enophthalmos (10-20% according to publications). The aim of bone substance reconstruction is to restore the volume and the internal shape of the orbit. The gold standard is autologous bone grafts. The surgery which usually lasts 2 to 3 hours depending on the number of walls involved, can lead to ophthalmological or esthetic complications. Its results are unsatisfactory, and the use of titanium implants would allow a reconstruction of the orbital volume more optimal than the autograft. The development of computer-assisted techniques permitted implants evolution: initially peri-operatively preformed, today patient specific implant can be obtained from data of CT-scan. In cranioplasties, a randomized study showed better results at 12 months of these implants compared to the autograft. Their success rate is close to 100% with less than 5% of postoperative complication, while the rate used for cortical graft reconstructions is 20-25%. Today, 3D printing of patient-specific porous titanium implants is possible. A study has shown that they al…
This description comes directly from the study's public registry record.
Jean-Thomas BACHELET · +33 4 26 73 26 44 · jean-thomas.bachelet@chu-lyon.fr
Magali HANSER · +33 4 72 11 57 65 · magali.hanser@chu-lyon.fr
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| Hospices Civils de Lyon, Groupement Hospitalier Sud Chirurgie maxillo-faciale | Pierre-Bénite, France | Recruiting |
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Source record: clinicaltrials.gov/study/NCT03608280