Multicenter Pilot Study to Assess a Biphasic Calcium Phosphate Implant for Functional and Aesthetic Septorhinoplasty
| dc.rights.license | open | en_US |
| dc.contributor.author | DE GABORY, Ludovic | |
| dc.contributor.author | BOUDARD, Philippe | |
| dc.contributor.author | BESSEDE, Jean Pierre | |
| hal.structure.identifier | Bordeaux population health [BPH] | |
| dc.contributor.author | MAILLARD, Aline | |
| dc.contributor.author | LACOMME, Sabrina | |
| dc.contributor.author | GONTIER, Etienne | |
| dc.contributor.author | DURAND, Marlene | |
| hal.structure.identifier | Bioingénierie tissulaire [BIOTIS] | |
| dc.contributor.author | FRICAIN, Jean-Christophe
ORCID: 0000-0001-7855-6437 | |
| hal.structure.identifier | Bordeaux population health [BPH] | |
| dc.contributor.author | BENARD, Antoine | |
| hal.structure.identifier | Bioingénierie tissulaire [BIOTIS] | |
| dc.contributor.author | BORDENAVE, Laurence
IDREF: 057389675 | |
| dc.date.accessioned | 2021-11-22T11:21:51Z | |
| dc.date.available | 2021-11-22T11:21:51Z | |
| dc.date.issued | 2021-09 | |
| dc.identifier.issn | 2689-3622 (Electronic) 2689-3614 (Linking) | en_US |
| dc.identifier.uri | https://oskar-bordeaux.fr/handle/20.500.12278/123911 | |
| dc.description.abstractEn | Importance: A validated biomaterial would have several medical advantages in septorhinoplasties requiring a large-volume graft such as avoiding donor site morbidity, making ambulatory surgery possible, and reducing surgical costs. Objective: To assess the safety and efficacy of a ceramic to treat saddle and crooked noses. The main endpoint was the biocompatibility of the implant. The secondary endpoint was its functional and aesthetic efficacy. Design, Setting, and Participants: The nasal septum (NASEPT) study is a pilot multicenter noncomparative prospective phase IIa clinical trial. The biomaterial tested was a biphasic calcium phosphate implant composed of 75% hydroxyapatite and 25% beta tri calcium phosphate. This versatile material can be used to replace septal skeleton when it is absent or nonusable. We included 25 patients with a multifractured osseous and cartilaginous framework after several traumas or surgeries. The implant placement technique was identical to an extracorporeal septoplasty through the external approach. Main Outcomes and Measures: The primary endpoint was the occurrence of expected adverse and severe adverse events. The secondary endpoints were clinical functional and aesthetic results and histological microscopic modifications. Results: Any extrusion, infection, pain, and epistaxis were observed. All implants were placed in a sagittal, straight, and solid position without extralobular depression. Comparisons between pre- and postoperative symptoms showed that nasal comfort (p < 10(-4)) and quality of life (p < 10(-4)) were dramatically improved in all patients. The nasolabial angle (p = 0.047) and the columellar projection (p = 0.024) were improved after surgery. Histological data showed little submucosal inflammation at 6 months with well-differentiated epithelium. The mean follow-up was 23 months: three patients underwent revision surgery for functional or aesthetic details and four implants were removed (16%) owing to a foreign body reaction between 17 and 74 months. Conclusion and Relevance: The NASEPT implant meets functional and aesthetic requirements in complex septorhinoplasties but its long-term biocompatibility needs to be improved. It could potentially avoid donor site morbidity. | |
| dc.language.iso | EN | en_US |
| dc.title.en | Multicenter Pilot Study to Assess a Biphasic Calcium Phosphate Implant for Functional and Aesthetic Septorhinoplasty | |
| dc.type | Article de revue | en_US |
| dc.identifier.doi | 10.1089/fpsam.2020.0184 | en_US |
| dc.subject.hal | Sciences du Vivant [q-bio]/Santé publique et épidémiologie | en_US |
| dc.identifier.pubmed | 32700976 | en_US |
| bordeaux.journal | Facial Plastic Surgery & Aesthetic Medicine | en_US |
| bordeaux.page | 321-329 | en_US |
| bordeaux.volume | 23 | en_US |
| bordeaux.hal.laboratories | Bordeaux Population Health Research Center (BPH) - UMR 1219 | en_US |
| bordeaux.issue | 5 | en_US |
| bordeaux.institution | Université de Bordeaux | en_US |
| bordeaux.institution | INSERM | en_US |
| bordeaux.institution | CNRS | |
| bordeaux.institution | CHU de Bordeaux | |
| bordeaux.institution | Institut Bergonié | |
| bordeaux.team | EMOS | en_US |
| bordeaux.team | PharmacoEpi-Drugs | en_US |
| bordeaux.peerReviewed | oui | en_US |
| bordeaux.inpress | non | en_US |
| hal.identifier | hal-03439639 | |
| hal.version | 1 | |
| hal.date.transferred | 2021-11-22T11:21:55Z | |
| hal.export | true | |
| dc.rights.cc | Pas de Licence CC | en_US |
| bordeaux.COinS | ctx_ver=Z39.88-2004&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.jtitle=Facial%20Plastic%20Surgery%20&%20Aesthetic%20Medicine&rft.date=2021-09&rft.volume=23&rft.issue=5&rft.spage=321-329&rft.epage=321-329&rft.eissn=2689-3622%20(Electronic)%202689-3614%20(Linking)&rft.issn=2689-3622%20(Electronic)%202689-3614%20(Linking)&rft.au=DE%20GABORY,%20Ludovic&BOUDARD,%20Philippe&BESSEDE,%20Jean%20Pierre&MAILLARD,%20Aline&LACOMME,%20Sabrina&rft.genre=article |
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