Prospective trial evaluating the long-term outcomes associated with the use of MTF allograft cartilage in cosmetic and reconstructive rhinoplasty procedures

Project: Research project

Project Details

Description

Autogenous cartilage is the most common source of graft material for nasal reconstruction and rhinoplasty. Autogenous cartilage is typically harvested from the septum, concha, and rib, and is widely utilized for structural support as well as for cosmetic contour. Most primary rhinoplasty procedures utilize septal and conchal cartilage, and most reconstructive procedures that require cartilage will utilize conchal cartilage. However, there are situations wherein septal or conchal cartilage is inadequate (secondary rhinoplasties, many ethnic rhinoplasties, procedures in older patients where cartilage can become mineralized and brittle, as well as complex reconstructive procedures) or unavailable. Common complications of autogenous grafts in rhinoplasties include resorption (0.5% to 5%3,4,5,8), infection (1.5% to 9%2,7,8), and warping (1 to 25.8%1,6,7,8,9). In addition, use of autogenous cartilage for nasal reconstruction has other significant drawbacks such as donor site morbidity (e.g. pneumothorax, septal perforations, bleeding) and long operating times required to harvest the graft. For this reason, allogeneic grafts have been proposed and utilized as an alternative graft source in rhinoplasty procedures. While cadaveric cartilage conceptually provides a good alternative to autogenous cartilage, problems with tissue integrity can arise due to the harsh processing procedures often used to achieve the sterility necessary for safe implantation. Common approaches to sterilizing allogenous cartilage include heat, hydrogen peroxide, and terminal sterility (ethylene oxide and gamma irradiation), all of which are convenient and effective at achieving sterilization; however, their effect on the structure and/or chemistry of the cadaveric cartilage may be detrimental, leading to decreased strength and efficacy following implantation.
Recently, a novel “off-the-shelf” FDA-approved pre-shaped costal cartilage allograft has became commercially available through the Musculoskeletal Transplant Foundation (MTF). What distinguishes MTF’s allograft cartilage is the Advanced Tissue Processing (ATP) method employed by MTF which yields safe, sterile allografts while preserving the integrity and function of the native tissue. This method of disinfecting the tissue exclusively uses aseptic techniques during all processing and packaging procedures and never uses terminal sterilization such as gamma irradiation, thus maintaining the quality of the allograft cartilage. MTF’s FDA-approved allograft cartilage provides a promising alternative to autograft cartilage for use in reconstructive and cosmetic rhinoplasties due to the high-quality of the graft and its ready accessibility, reduced operative times, and elimination of donor site morbidity. The purpose of this prospective, randomized, non-inferiority protocol is to compare MTF’s allograft costal cartilage with autograft costal cartilage with respect to clinical utility, stability, cost, and complications in reconstructive and cosmetic rhinoplasty.
Hypothesis:
We hypothesize that patient satisfaction, complication rates, and cost associated with rhinoplasties performed using MTF’s allograft costal cartilage are comparable to those performed using autograft costal cartilage.
StatusActive
Effective start/end date10/20/164/30/21

Funding

  • Musculoskeletal Transplant Foundation, Inc. (Agreement 10/15/16)

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