Cartilage Remodeling Using Low-Temperature Radiofrequency for Facial Reconstruction
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Indiana University
- Enrollment
- 20
- Locations
- 6
- Primary Endpoint
- Number of treatments needed to reach desired shape
Study Overview
Brief Summary
The goal of this study is to evaluate the efficacy of using the Vivaer low-temperature radio-frequency (LTRF) device to reshape ex-vivo human nasal or auricular cartilage for use in cosmetic and functional septorhinoplasty. The investigators hope to answer the following questions:
- How many LTRF treatments are needed to achieve the desired shape in a given cartilage specimen
- How does an LTRF treatment quantitatively affect both length and angulation of a cartilage specimen
- How does physician satisfaction with cosmetic outcome compare to cases treated with existing septorhinoplasty techniques
- How do changes in patient reported measures of nasal obstruction (NOSE score) pre- and post-surgery compare to cases treated with existing septorhinoplasty techniques
- Does using LTRF during septorhinoplasty significantly increase total operative time
- Are rates of adverse events when using LTRF different from cases treated with existing septorhinoplasty techniques
Participants will complete the NOSE questionnaire at their pre-operative visit. Participants undergoing cosmetic septhorhinoplasty will also be photographed in standard fashion for facial analysis.
During scheduled septorhinoplasty surgery, the Vivaer LTRF device will be used to reshape nasal and/or auricular cartilage ex-vivo prior to reimplantation at the discretion of the Principal Investigator in order to optimize functional and cosmetic outcome.
Participants will follow up at approximately 1 week and 1 month after surgery. At 1 month, the NOSE questionnaire will be readministered to all participants, and cosmetic patients will be photographed again.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients 18 years and older undergoing functional septorhinoplasty or cosmetic septorhinoplasty, with or without auricular cartilage harvest
Exclusion Criteria
- •Patients who have had a prior septorhinoplasty
- •Patients who have received prior head and neck radiation
- •Patients with a septal perforation
- •Patients who are medically ineligible to undergo septorhinoplasty.
Arms & Interventions
Low-temperature radio-frequency reshaping intervention
All enrolled subjects will receive the intervention outlined in the section titled "Study Design".
Intervention: Low-temperature radio-frequency reshaping of autologous cartilage nasal and/or auricular cartilage (Device)
Outcomes
Primary Outcomes
Number of treatments needed to reach desired shape
Time Frame: Immediately pre and post intervention (intraoperative)
The primary outcome measure will be the efficacy of reshaping cartilage from straight to curved and from curved to straight for use in septorhinoplasty. The number of treatments needed to create the desired shapes and curvatures will be measured for each cartilage specimen.
Secondary Outcomes
- Change in specimen curvature(Immediately pre and post intervention (intraoperative))
- Change in specimen length(Immediately pre and post intervention (intraoperative))
- Nasal Obstruction Symptom Evaluation (NOSE) score(Baseline and one month)
- Physician satisfaction with cosmetic outcome(Baseline and one month)
Investigators
Taha Shipchandler
Division Chief of Facial Plastic and Reconstructive Surgery in the Department of Otolaryngology-Head and Neck Surgery
Indiana University