Use of Titanium Plate in Rhinoplasty in Patients With Cleft Lip and Palate : Aesthetic and Functional Impact. (PETROL/TROPHIC)
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|ClinicalTrials.gov Identifier: NCT03572907|
Recruitment Status : Withdrawn (Investigators decision)
First Posted : June 28, 2018
Last Update Posted : March 19, 2019
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.
|Condition or disease||Intervention/treatment|
|Cleft Lip Cleft Palate||Other: Rhinoplasty questionnaire|
|Study Type :||Observational|
|Actual Enrollment :||0 participants|
|Official Title:||Use of Titanium Plate in Rhinoplasty in Patients With Cleft Lip and Palate: Aesthetic and Functional Impact. TROPIC (Titanium RhinOPlasty ImpaCt)|
|Estimated Study Start Date :||October 2018|
|Estimated Primary Completion Date :||February 2019|
|Estimated Study Completion Date :||February 2019|
- Other: Rhinoplasty questionnaire
Each patient will complete a validated rhinoplasty questionnaire (Rhinoplasty Outcome Evaluation) before and after the intervention
- Rhinoplasty Outcome Evaluation scores [ Time Frame: 1 month ]
Comparison of pre- and postoperative ROE (Rhinoplasty Outcome Evaluation) scores in patients with cleft lip and palate who benefited from the placement of a titanium columellar strut.
Each patient completes the questionnaire before and after the intervention. Then the investigators compare these scores to evaluate the improvement.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03572907
|Service de chirurgie maxillo-faciale - Hôpital de la Croix Rousse - Groupement Hospitalier Nord - Hospices Civils de Lyon|
|Lyon, France, 69004|