Use of Allograft Cartilage in Cosmetic and Reconstructive Rhinoplasty

Prospective Trial Evaluation the Long-term Outcomes Associated With the Use of MTF Allograft Cartilage in Cosmetic and Reconstructive Rhinoplasty Procedures

This is a single-center, blinded, controlled trial, conducted in healthy adult subjects undergoing a reconstructive or cosmetic rhinoplasty involving the use of cartilaginous graft (either non-irradiated cartilage sheet allograft compared to autologous harvest and grafting of costal cartilage).

Study Overview

• Status: Completed
• Conditions: Rhinoplasty
• Intervention / Treatment: Other: Autologous Costal Cartilage Graft; Other: Costal Cartilage Allograft.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subject is scheduled to undergo a reconstructive or cosmetic surgical procedure to alter the appearance of the nose that is anticipated to require a cartilage graft.
• Subject is willing to sign an informed consent.
• Subject is a non-smoker or has stopped smoking at least 6-weeks prior to inclusion in the study.
• Subjects must agree to forgo any treatment, medical or non-medical, to the area treated in this study, for the duration of the 1-year post-treatment evaluation period, unless there is prior approval from the investigator.

Exclusion Criteria:

• Presence of significant endocrine, immunologic, dermatologic or psychiatric abnormalities that would render the subject an inappropriate candidate for the study.
• Presence of any malignancy not considered cured in the midface area specifically (no evidence of cancer recurrence in the previous five years).
• History of radiation to the area(s) to be treated in the study.
• Subjects taking chronic steroids (injected or oral) or other immune modulators.
• Subjects with a history of skin sensitivity (dermatitis) to either the suture materials or dressings to be utilized during the course of this study.
• Subjects with skin conditions that could result in poor healing or widened scars.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Autologous Costal Cartilage Graft; Patients undergoing rhinoplasty will receive autologous rib graft.	Other: Autologous Costal Cartilage Graft; Subjects undergoing either reconstructive or cosmetic rhinoplasty will choose which graft will be used in their intervention.
Other: Costal Cartilage Allograft; Patients undergoing rhinoplasty will receive costal cartilage allograft.	Other: Costal Cartilage Allograft.; Subjects undergoing either reconstructive or cosmetic rhinoplasty will choose which graft will be used in their intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Outcome Assessment	Subjective assessment using the Face-Q checklists and scoring for preoperative assessment.	Preoperative
Patient Outcome Assessment	Subjective assessment using the Face-Q checklists and scoring for post-operative assessments.	3 months post-operative
Patient Outcome Assessment	Subjective assessment using the Face-Q checklists and scoring for post-operative assessments.	6 months post-operative
Patient Outcome Assessment	Subjective assessment using the Face-Q checklists and scoring for post-operative assessments.	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Cost analysis of utilizing the different grafts as far as graft cost, operative time, re-operation, etc.	12 months
Comparison of the overall complication rate between the MTF cartilage graft and autologous cartilage graft used during the procedures.	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety: occurrence of adverse events (AEs)	Evaluation of the occurrence of adverse events (AEs) as documented by the treating physician during the course of treatment and follow-up visits and as reported by the subjects at each Assessment Visit.	12 months

Collaborators and Investigators

• Sponsor: Musculoskeletal Transplant Foundation

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2017
• Primary Completion (Actual): October 1, 2020
• Study Completion (Actual): October 1, 2020

Study Registration Dates

• First Submitted: September 28, 2022
• First Submitted That Met QC Criteria: September 30, 2022
• First Posted (Actual): October 4, 2022

Study Record Updates

• Last Update Posted (Actual): October 4, 2022
• Last Update Submitted That Met QC Criteria: September 30, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: MTF Profile Study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No