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

NCT03572907 | Withdrawn

• 1 other identifier: 69HCL18_0328
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Cleft Lip; Cleft Palate

Outcome Measures

Primary Outcomes (1)

• Rhinoplasty Outcome Evaluation scores

  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.

  1 month

Interventions

Rhinoplasty questionnaire OTHER

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

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with cleft lip and palate who underwent secondary rhinoplasty using a titanium columelar strut between March 1, 2016 and March 1, 2018.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Service de chirurgie maxillo-faciale - Hôpital de la Croix Rousse - Groupement Hospitalier Nord - Hospices Civils de Lyon

Lyon, 69004, France

Location

MeSH Terms

Conditions

Cleft Lip; Cleft Palate

Condition Hierarchy (Ancestors)

Lip Diseases; Mouth Diseases; Stomatognathic Diseases; Mouth Abnormalities; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Jaw Abnormalities; Jaw Diseases; Musculoskeletal Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2018
• First Posted: June 28, 2018
• Study Start: October 1, 2018
• Primary Completion: February 1, 2019
• Study Completion: February 1, 2019
• Last Updated: March 19, 2019

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)