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Clinical Trials/NCT03572907
NCT03572907
Withdrawn
Not Applicable

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

Hospices Civils de Lyon1 site in 1 countryOctober 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cleft Lip
Sponsor
Hospices Civils de Lyon
Locations
1
Primary Endpoint
Rhinoplasty Outcome Evaluation scores
Status
Withdrawn
Last Updated
7 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
October 2018
End Date
February 2019
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • patient over 12 years
  • patients with cleft lip and palate operated by Pr Gleizal of a secondary rhinoplasty using a titanium columellar strut
  • between January 1, 2016 and March 1, 2018
  • patient not having opposed their participation

Exclusion Criteria

  • patient not mastering the French language
  • patient participating in interventional research

Outcomes

Primary Outcomes

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.

Study Sites (1)

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