Abstract
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.
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