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

Sponsor
Hospices Civils de Lyon (Other)
Overall Status
Withdrawn
CT.gov ID
NCT03572907
Collaborator
(none)
0
1
4
0

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Rhinoplasty questionnaire

Study Design

Study Type:
Observational
Actual Enrollment :
0 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Use of Titanium Plate in Rhinoplasty in Patients With Cleft Lip and Palate: Aesthetic and Functional Impact. TROPIC (Titanium RhinOPlasty ImpaCt)
Anticipated Study Start Date :
Oct 1, 2018
Anticipated Primary Completion Date :
Feb 1, 2019
Anticipated Study Completion Date :
Feb 1, 2019

Outcome Measures

Primary Outcome Measures

  1. Rhinoplasty Outcome Evaluation scores [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
12 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Service de chirurgie maxillo-faciale - Hôpital de la Croix Rousse - Groupement Hospitalier Nord - Hospices Civils de Lyon Lyon France 69004

Sponsors and Collaborators

  • Hospices Civils de Lyon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT03572907
Other Study ID Numbers:
  • 69HCL18_0328
First Posted:
Jun 28, 2018
Last Update Posted:
Mar 19, 2019
Last Verified:
Jun 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 19, 2019