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Assessment of bioabsorbable implant treatment for nasal valve collapse compared to a sham group: a randomized control trial.

ABSTRACT: BACKGROUND:Dynamic nasal valve collapse (NVC) is a common factor contributing to nasal obstruction; however, it is often underdiagnosed and untreated. An in-office, minimally invasive procedure addressing dynamic NVC uses a bioabsorbable implant (Latera) to support the lateral nasal wall. This study aimed to evaluate the safety and effectiveness of the treatment in a randomized controlled trial (RCT) with sham control. METHODS:In this prospective, multicenter, single-blinded RCT, 137 patients from 10 clinics were randomized into 2 arms: treatment arm (70 patients) and sham control arm (67 patients). Outcome measures were followed through 3 months after the procedure. The primary endpoint was the responder rate (percentage of patients with reduction in clinical severity by ?1 category or ?20% reduction in Nasal Obstruction Symptom Evaluation [NOSE] score). RESULTS:Before the procedure, there were no statistically significant differences in patient demographics and nasal obstruction symptom measures between the 2 arms. Three months after the procedure, responder rate was significantly higher for the treatment arm compared to the control (82.5% vs 54.7%, p = 0.001). Patients in the treatment arm also had a significantly greater decrease in NOSE score (-42.4 ± 23.4 vs -22.7 ± 27.9, p < 0.0001) and significantly lower visual analogue scale (VAS) scores (-39.0 ± 29.7 vs -13.3 ± 30.0, p < 0.0001) than the sham control arm. Seventeen patients reported 19 procedure/implant-related adverse events, all of which resolved with no clinical sequelae. CONCLUSION:Our study shows the safety and effectiveness of the bioabsorbable implant in reducing patients' nasal obstruction symptoms.

SUBMITTER: Stolovitzky P

PROVIDER: S-EPMC6771676 | biostudies-literature | 2019 Aug

REPOSITORIES: biostudies-literature

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Assessment of bioabsorbable implant treatment for nasal valve collapse compared to a sham group: a randomized control trial.

Stolovitzky Pablo P Senior Brent B Ow Randall A RA Mehendale Neelesh N Bikhazi Nadim N Sidle Douglas M DM

International forum of allergy & rhinology 20190621 8

<h4>Background</h4>Dynamic nasal valve collapse (NVC) is a common factor contributing to nasal obstruction; however, it is often underdiagnosed and untreated. An in-office, minimally invasive procedure addressing dynamic NVC uses a bioabsorbable implant (Latera) to support the lateral nasal wall. This study aimed to evaluate the safety and effectiveness of the treatment in a randomized controlled trial (RCT) with sham control.<h4>Methods</h4>In this prospective, multicenter, single-blinded RCT, ...[more]

PMID: 31226238

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Project description:BACKGROUND:Scaphoid excision and four-corner arthrodesis is an acceptable salvage procedure for the treatment of scapholunate advanced collapse (SLAC) and scaphoid nonunion advanced collapse (SNAC) wrists, since first popularized in the 1980s. We investigated the potential application of novel bioabsorbable plates and screws made of un-sintered hydroxyapatite/poly-L-lactide composite for the treatment of metacarpal fractures. We used this material for the fixation of four-corner fusions for SLAC or SNAC wrists commencing from April 2009. The purpose of this study was to clarify the controversy in the literature regarding the use of these plates. METHODS:The surgical procedures and clinical outcomes of four-corner fusions using a bioabsorbable (poly-L-lactic acid and hydroxyapatite) plate were reported. Ten patients (mean age, 59.2?years) with SLAC or SNAC wrists underwent fusions between April 2009 and June 2016. The primary diseases were scapholunate ligament injury, Preiser disease, and scaphoid pseudarthrosis. The mean postoperative follow-up period was 45.9?months (range, 12-86). RESULTS:In all patients, bone union was achieved without dislocation or pain. The mean wrist flexion and extension arc improved from 78.5 degrees before surgery to 90.5 degrees after surgery. Mean grip strength improved from 51 to 69% after surgery, and the Quick Disabilities of the Arm, Shoulder, and Hand (QuickDASH) score improved from 53.5 to 14.3. No complications such as infection, avascular swelling, or tendon adhesion were observed. This implant requires no removal of internal fixation devices, produces stable outcomes, and is an effective fusion technique. CONCLUSIONS:We summarized the outcomes of four-corner arthrodesis using bioabsorbable plates. Satisfactory clinical results were shown, with no obvious complications. This novel plate also serves as a good alternative for patients who are allergic to metals. Furthermore, bioabsorbable plates are advantageous as they do not require removal.

Project description:ContextHeart Rate Variability (HRV) indicates how heart rate changes in response to inner and external stimuli. HRV is linked to health status and it is an indirect marker of the autonomic nervous system (ANS) function.ObjectiveTo investigate the influence of osteopathic manipulative treatment (OMT) on cardiac autonomic modulation in healthy subjects, compared with sham therapy and control group.MethodsSixty-six healthy subjects, both male and female, were included in the present 3-armed randomized placebo controlled within subject cross-over single blinded study. Participants were asymptomatic adults (26.7 ± 8.4 y, 51% male, BMI 18.5 ± 4.8), both smokers and non-smokers and not on medications. At enrollment subjects were randomized in three groups: A, B, C. Standardized structural evaluation followed by a patient need-based osteopathic treatment was performed in the first session of group A and in the second session of group B. Standardized evaluation followed by a protocoled sham treatment was provided in the second session of group A and in the first session of group B. No intervention was performed in the two sessions of group C, acting as a time-control. The trial was registered on clinicaltrials.gov identifier: NCT01908920.Main outcomes measuresHRV was calculated from electrocardiography before, during and after the intervention, for a total amount time of 25 min and considering frequency domain as well as linear and non-linear methods as outcome measures.ResultsOMT engendered a statistically significant increase of parasympathetic activity, as shown by High Frequency power (p < 0.001), expressed in normalized and absolute unit, and possibly decrease of sympathetic activity, as revealed by Low Frequency power (p < 0.01); results also showed a reduction of Low Frequency/High Frequency ratio (p < 0.001) and Detrended fluctuation scaling exponent (p < 0.05).ConclusionsFindings suggested that OMT can influence ANS activity increasing parasympathetic function and decreasing sympathetic activity, compared to sham therapy and control group.

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Assessment of bioabsorbable implant treatment for nasal valve collapse compared to a sham group: a randomized control trial.

Publications

Assessment of bioabsorbable implant treatment for nasal valve collapse compared to a sham group: a randomized control trial.

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