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临床试验/NCT03793218
NCT03793218撤回不适用

A Comparison of Alar Batten Graft to the Latera Nasal Implant for the Treatment of Nasal Valve Collapse

University of Virginia0 个研究点开始时间: 2018年8月28日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
主要终点
12 Month NOSE Score

研究概览

简要总结

Nasal obstruction is a common complaint for the patient presenting to the Otolaryngologist and/or the Facial Plastic surgeon. There are numerous potential causes of nasal obstruction, with more easily addressed pathologies such as posterior septal deviation and inferior turbinate hypertrophy often being over-diagnosed. Nasal valve obstruction, particularly dynamic nasal sidewall collapse, is of significant interest to the rhinoplasty surgeon. Traditionally, collapse of the nasal sidewall has been addressed via structural cartilage grafting, with alar batten grafting being the most commonly used method to provide support to the weak nasal sidewall. Recently, an absorbable nasal implant, comprised of a polylactic acid copolymer, has been advocated for supporting the nasal sidewall and relieving nasal obstruction. There are several proposed advantages of the implant over traditional operative techniques, namely the ease of endonasal insertion, which can be performed in the outpatient clinic setting. Preliminary investigations demonstrate subjective improvement in nasal obstruction with use of the implant, however, there has been no direct comparison with traditional techniques utilizing cartilage grafting.

This study is being done at both UVa and in Oregon. This prospective study will randomize patients with nasal obstruction and documented dynamic nasal sidewall collapse into one of two groups undergoing treatment with either endonasal batten grafting or the absorbable Latera nasal valve implant. Preoperative and postoperative nasal obstruction will be assessed with a validated survey for nasal obstructive symptoms, the Nasal Obstruction Symptom Evaluation (NOSE) score. The mean preoperative and postoperative NOSE score between the groups will be compared at 1, 6, 12, and 24 months post-operatively to compare the efficacy of both techniques. Subjects will be blinded to the surgical intervention they receive.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Documented physical exam findings of septal deviation
  • Bilateral nasal sidewall collapse on inspiration
  • Subjective improvement in nasal obstruction with use of the modified Cottle maneuver

排除标准

  • Prior septorhinoplasty
  • Obvious trauma to the nose causing nasal obstruction
  • Inflammatory conditions such as chronic rhinosinusitis with nasal polyposis
  • Patients using chronic topical nasal decongestants or illicit intranasal drug use
  • Prisoners, cognitively impaired, non-English speaking subjects

结局指标

主要结局

12 Month NOSE Score

时间窗: 12 months

Mean change in Nose score at 12 month post-op visit

次要结局

  • 24 Month NOSE Score(24 months)
  • 1 Month NOSE Score(1 month)
  • 6 Month NOSE Score(6 months)

研究者

申办方类型
Other
责任方
Sponsor

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Alar Batten Graft vs Latera for Nasal Valve Collapse | 临床试验