T-06 – Results of the first implantations of Ceramil® prosthesis, a new device for sternal replacement

Jérémy Tricard, Alessandro Piccardo, Nicolas Pichon, Denis Asselineau, François Bertin

Institution : Service de chirurgie thoracique et cardiovasculaire et angiologie, CHU Dupuytren, Limoges

Objectives : Many materials have been proposed to be used in reconstructive surgery of the chest wall but none has emerged as an ideal substitute. The Ceramil® prosthesis is an innovating material for replacement of the sternum. We present the device, the implantation technique and the follow-up of the first 4 recipients.

Methods : The Ceramil® prosthesis is a porous alumina ceramic which is a pure compound of mineral origin that presents osteointegration and biocompatibility properties. Its size is adapted to the sternal defect and chosen before the surgery among different made-to-measure models. Its implantation does not require osteosynthesis equipment. From March 2015 to March 2016, 4 patients underwent surgery for sternal replacement and received the Ceramil® prothesis. A 54-year old patient (n°1) had a radiation-induced sarcoma after a radiotherapy for breast cancer, a 61-year old patient (n°2) had a sternal necrosis due to a mediastinitis after sternotomy, 2 patients of 53 and 37 years old (n°3 and 4) had sternal metastasis from breast neoplasia.

Results : Patient n°1 was reoperated on D7 for a seroma. After an 19-month follow-up, she was not dyspneic (grade 1 of the CEE scale) and had no sternal pain or scarring disorder. Patient n°2 was reoperated after 3 months for wound care and closure as he presented with tissue necrosis due to a history of chest radiotherapy. After a 14-month follow-up, he presented with grade 2 dyspnea, sternal pain graded as 3 on the visual analog scale (VAS) and the operation wound was healed. After an 11-month follow-up, patient n°3 was not dyspneic and had no sternal pain or scarring disorder. After a 7-month follow-up, patient n°4 presented with grade 2 dyspnea, sternal pain graded as 3 on the VAS and no scarring disorder.

Conclusion : The Ceramil® prosthesis implanted as a replacement for the sternum appears to be reliable, reproducible and promising. A monocentric study (STOIC) and a multi-center study (ISBA) are currently performed.