NCT03572907

Use of Titanium Plate in Rhinoplasty in Patients With Cleft Lip and Palate : Aesthetic and Functional Impact.

Use of Titanium Plate in Rhinoplasty in Patients With Cleft Lip and Palate: Aesthetic and Functional Impact. TROPIC (Titanium RhinOPlasty ImpaCt)

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

The patients in this study are all born with a cleft lip and palate. They underwent several interventions in childhood to take care of it. Professor Gleizal offered them a secondary rhinoplasty aimed at normalizing the appearance of their nose. In this malformative and multioperated context, typical nasal deformities affect the tip of the nose, which appears to be sagging and asymmetrical. Scarred soft tissues exert an important retractile force against which conventional rhinoplasty techniques often remain insufficient. The use of columellar struts makes it possible to give again projection to the tip of the nose but when this strut is made from cartilage or bone, it is absorbed with the time. Moreover, these interventions require a remote removal of the site of interest (costal cartilage, tibial crest, calvaria) which generates additional morbidity. The investigators propose an alternative using a synthetic graft of titanium. This material has been used for many years for its excellent biocompatibility and trauma resistance. 28 patients were able to benefit from this technique between March 1, 2016 and March 1, 2018. The investigators wish to evaluate the aesthetic and functional results from the patient's point of view by submitting them to one validated rhinoplasty questionnaire after the end of the patient's inclusion.

Conditions

• Cleft Lip
• Cleft Palate

Interventions

Type	Name	Description
OTHER	Rhinoplasty questionnaire	Each patient will complete a validated rhinoplasty questionnaire (Rhinoplasty Outcome Evaluation) before and after the intervention

Timeline

• Start date: 2018-10-01
• Primary completion: 2019-02-01
• Completion: 2019-02-01
• First posted: 2018-06-28
• Last updated: 2019-03-19

Locations

1 site across 1 country: France