ABSTRACT
Benefits of a direct anterior approach (DAA) versus a posterior-lateral (PA) approach to THA were assessed in a single-surgeon, IRB-approved, prospective, randomized clinical study. Subjects (43 DAA and 44 PA) were evaluated at 6 weeks, and 3, 6 and 12 months. The primary end point was ability to climb stairs normally and walk unlimited at each time point. Secondary end points included assessment by several outcome instruments. DAA subjects performed better during the immediate post-operative period; they had lower VAS pain scores on the first post-operative day, more subjects climbing stairs normally and walking unlimited at 6 weeks, and higher HOOS Symptoms scores at 3 months. There were no significant differences between groups at later time points. Findings confirm previous reports of benefits of DAA versus PA in early post-operative phases.
Subject(s)
Arthroplasty, Replacement, Hip/methods , Aged , Female , Humans , Male , Middle Aged , Prospective StudiesABSTRACT
OBJECTIVES/HYPOTHESIS: To assess balloon dilation of the Eustachian tube with Eustachian tube balloon catheter in conjunction with medical management as treatment for Eustachian tube dilatory dysfunction. STUDY DESIGN: In this prospective, multicenter, randomized, controlled trial, we assigned, in a 2:1 ratio, patients age 22 years and older with Eustachian tube dilatory dysfunction refractory to medical therapy to undergo balloon dilation of the Eustachian tube with balloon catheter in conjunction with medical management or medical management alone. METHODS: The primary endpoint was normalization of tympanogram at 6 weeks. Additional endpoints were normalization of Eustachian Tube Dysfunction Questionaire-7 symptom scores, positive Valsalva maneuver, mucosal inflammation, and safety. RESULTS: Primary efficacy results demonstrated superiority of balloon dilation of the Eustachian tube with balloon catheter + medical management compared to medical management alone. Tympanogram normalization at 6-week follow-up was observed in 51.8% (72/139) of investigational patients versus 13.9% (10/72) of controls (P < .0001). Tympanogram normalization in the treatment group was 62.2% after 24 weeks. Normalization of Eustachian Tube Dysfunction Questionaire-7 Symptom scores at 6-week follow-up was observed in 56.2% (77/137) of investigational patients versus 8.5% (6/71) controls (P < .001). The investigational group also demonstrated substantial improvement in both mucosal inflammation and Valsalva maneuver at 6-week follow-up compared to controls. No device- or procedure-related serious adverse events were reported for those who underwent balloon dilation of the Eustachian tube. CONCLUSIONS: This study demonstrated superiority of balloon dilation of the Eustachian tube with balloon catheter + medical management compared to medical management alone to treat Eustachian tube dilatory dysfunction in adults. LEVEL OF EVIDENCE: 1b. Laryngoscope, 128:1200-1206, 2018.