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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Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03572907
Acronym
PETROL/TROPHIC
Enrollment
0
Registered
2018-06-28
Start date
2018-10-31
Completion date
2019-02-28
Last updated
2019-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cleft Lip, Cleft Palate

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.

Interventions

OTHERRhinoplasty questionnaire

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

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Rhinoplasty Outcome Evaluation scores1 monthComparison 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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026