Sternal replacement with alumina ceramic prosthesis after oncological resection

No gold standard method exists for sternal replacement. A ceramic prosthesis (CERAMIL) was developed with the aim to comply with “ideal” sternal substitute requirements. We conducted a multicentric post-market surveillance study, independent of the manufacturer, to evaluate the safety and the effectiveness of the device. CERAMIL is a porous alumina sternal prosthesis. Appropriate size is per-operatively chosen using templates. The device is anchored with sutures after mediastinum protection with mesh. No metallic fixation is needed. Between March 2015 and October 2022, 53 non-infected malignant sternal tumors were treated in 19 centers from 7 countries. Thirty-seven female (70 %) and 16 male (30 %) patients with a median age of 56 (13–79) underwent the procedure. Indications were sternal cancers (n = 25) and metastasis (n = 28). Twenty-nine grade ≥ IIIA-complications occurred in 15 patients (28 %); 9 of them were early reoperated (17 %). Chest wall stability was achieved for all patients. One postoperative death occurred because of septic complications. Median intensive care unit and hospital lengths of stay were respectively 2 (0–44) and 13 days (6–52). Eight patients presented non-free margins (15 %), 2 patients experienced palliative resection (4 %). After 14 months of median follow-up (1,5–67), 5 prosthesis removals were required (9 %): 4 wound infections, 1 hemomediastinum. Seven patients died during the follow-up (13 %): 1 postoperative death, 6 cancer evolutions. Sternal replacement with the CERAMIL prosthesis could be a promising technique with acceptable outcomes to manage this challenging condition. The easy implantation technique ensuring chest wall stability is a device key advantage.

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Publication Details

Journal
Asian Journal of Surgery
Published
2025-04-18
DOI
https://doi.org/10.1016/j.asjsur.2025.02.222
Primary Topic
Reconstructive Surgery and Microvascular Techniques
Type
article
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article

Sternal replacement with alumina ceramic prosthesis after oncological resection

P. A. Thomas, Jérémy Tricard, François Bertin, Kheira Hireche et al.
Asian Journal of Surgery
Reconstructive Surgery and Microvascular Techniques
article

Sternal replacement with alumina ceramic prosthesis after oncological resection

P. A. Thomas, Jérémy Tricard, François Bertin, Kheira Hireche, Xavier Benoît D’Journo, Anaëlle Chermat, Maciej Głogowski
article en

Abstract

No gold standard method exists for sternal replacement. A ceramic prosthesis (CERAMIL) was developed with the aim to comply with “ideal” sternal substitute requirements. We conducted a multicentric post-market surveillance study, independent of the manufacturer, to evaluate the safety and the effectiveness of the device. CERAMIL is a porous alumina sternal prosthesis. Appropriate size is per-operatively chosen using templates. The device is anchored with sutures after mediastinum protection with mesh. No metallic fixation is needed. Between March 2015 and October 2022, 53 non-infected malignant sternal tumors were treated in 19 centers from 7 countries. Thirty-seven female (70 %) and 16 male (30 %) patients with a median age of 56 (13–79) underwent the procedure. Indications were sternal cancers (n = 25) and metastasis (n = 28). Twenty-nine grade ≥ IIIA-complications occurred in 15 patients (28 %); 9 of them were early reoperated (17 %). Chest wall stability was achieved for all patients. One postoperative death occurred because of septic complications. Median intensive care unit and hospital lengths of stay were respectively 2 (0–44) and 13 days (6–52). Eight patients presented non-free margins (15 %), 2 patients experienced palliative resection (4 %). After 14 months of median follow-up (1,5–67), 5 prosthesis removals were required (9 %): 4 wound infections, 1 hemomediastinum. Seven patients died during the follow-up (13 %): 1 postoperative death, 6 cancer evolutions. Sternal replacement with the CERAMIL prosthesis could be a promising technique with acceptable outcomes to manage this challenging condition. The easy implantation technique ensuring chest wall stability is a device key advantage.

Asian Journal of SurgeryVol. 48(6)
Centre National de la Recherche Scientifique (FR), Inserm (FR), Aix-Marseille Université (FR), Centre Hospitalier Universitaire de Montpellier (FR), Hôpital Nord (FR), National Institute of Oncology (HU), Université de Limoges (FR)
Zero hunger
Openalex Percentile: Top 86%
Reconstructive Surgery and Microvascular Techniques
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