REMODEL
Prospective, multicenter, randomized, controlled trial.
Study
Overview
REMODEL is the first prospective, multicenter, open-label, randomized, controlled trial with sufficient statistical power to compare standalone Balloon Sinus Dilation to the standard of care, Functional Endoscopic Sinus Surgery (FESS) for the treatment of medically refractory CRS.
Treatment
Balloon dilation of maxillary ostia and ethmoid infundibula
Control
Maxillary antrostomy and uncinectomy with or without anterior ethmoidectomy
Inclusion criteria
- Age ≥ 18 years
- Uncomplicated chronic rhinosinusitis of the maxillary sinuses with or without anterior ethmoid disease
- Diagnosed with chronic or recurrent acute rhinosinusitis per the 2007 adult sinusitis clinical practice guidelines
- Patients met nationally recognized criteria for medically necessary functional endoscopic sinus surgery. (Anthem Coverage Guideline or BlueCross BlueShield of North Carolina Medical Policy)
Exclusion criteria
- Disease in the frontal, posterior ethmoid or sphenoid sinuses that requires surgery
- Fungal disease
- Gross polypoid disease
- Require concurrent nasal surgery or have had previous sinus surgery
- Nasal surgery within 3 months prior to enrollment
- Severe septal deviation causing obstruction of the OMC
- Primary ciliary dysfunction
- Hemophilia
- Samter’s Triad
Outcomes and
results
Balloon dilation (74 patients)
- 99.3% technical success rate
- 145 of 146 dilations of the maxillary ostia/ethmoid infundibula were successfully completed
FESS (61 patients)
- 99.4% technical success rate
- 118 of 119 attempted maxillary antrostomies with uncinectomies were successfully completed
- 47 concomitant anterior ethmoidectomies in 25 patients
Summary
130/135 patients treated (96.3%) completed 12-Month follow-up; 66/66 (100%) and 25/25 (100%) completed 18 and 24 month follow-up, respectively
Conclusions
Benefits of balloon dilation compared to FESS
- Less bleeding
- Reduced use of postoperative pain medication
- Faster patient recovery
- Fewer debridements
Balloon dilation has comparable efficacy as FESS
- Long-term symptom improvement
- Reduction in acute sinus exacerbations
- Ostial patency
- Very low surgical revision rates
Standalone balloon dilation performed in the physician’s office is proven to be safe, effective, and a beneficial alternative to FESS in patients with uncomplicated CRS.
Featured publications
Chandra RK, Kern RC, Cutler JL, Welch KC, Russell PT. REMODEL larger cohort with long-term outcomes and meta-analysis of standalone balloon dilation studies. Laryngoscope. 2016 Jan;126(1):44-50.
Bikhazi N, Light J, Truitt T, Schwartz M, Cutler J; REMODEL Study Investigators. Standalone balloon dilation versus sinus surgery for chronic rhinosinusitis: A prospective, multicenter, randomized, controlled trial with 1-year follow-up. Am J Rhinol Allergy. 2014 Jul-Aug;28(4);323-9.
Cutler J, Bikhazi N, Light J, Truitt T, Schwartz M; REMODEL Study Investigators. Standalone balloon dilation versus sinus surgery for chronic rhinosinusitis: A prospective, multicenter, randomized, controlled trial. Am J Rhinol Allergy. 2013 Sep-Oct;27(5):416-22.
Sinusitis
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