title: Effect of Naproxen Prophylaxis on Heterotopic Ossification Following Hip Arthroscopy: A Double-Blind Randomized Placebo-Controlled Trial.
abstract: BACKGROUND
  Heterotopic ossification (HO) is a known complication of hip arthroscopy. Our objective was to determine the effect of postoperative naproxen therapy on the development of HO following arthroscopic surgery for femoroacetabular impingement.
  
  
  METHODS
  Between August 2011 and April 2013, 108 eligible patients were enrolled and randomized to take naproxen or a placebo for three weeks postoperatively. Radiographs were made at routine follow-up visits for one year following surgery. The primary outcome measure was the development of HO, as classified with the Brooker criteria and two-dimensional measurements on radiographs made at least seventy-five days postoperatively (average, 322 days). The primary analysis, performed with a Fisher exact test, compared the proportion of subjects with HO between the treatment and control groups. A single a priori interim analysis was planned at the midpoint of the study.
  
  
  RESULTS
  Our data safety and monitoring board stopped this study when the interim analysis showed that the stopping criterion had been met for demonstration of efficacy of the naproxen intervention. The prevalence of HO was 46% (twenty-two of the forty-eight in the final analysis) in the placebo group versus 4% (two of forty-eight) in the naproxen group (p < 0.001). Medication compliance was 69% overall, but it did not differ between the naproxen and placebo groups. Minor adverse reactions to the study medications were reported in 42% of the patients taking naproxen versus 35% of those taking the placebo (p = 0.45).
  
  
  CONCLUSIONS
  In this trial, prophylaxis with naproxen was effective in reducing the prevalence of HO without medication-related morbidity.
authors.affiliation: Department of Orthopaedic Surgery, University of Utah, 590 Wakara Way, Salt Lake City, UT 84108.
authors.forename: James T
authors.initials: JT
authors.lastname: Beckmann
authors.affiliation: Department of Orthopaedic Surgery, University of Utah, 590 Wakara Way, Salt Lake City, UT 84108.
authors.forename: James D
authors.initials: JD
authors.lastname: Wylie
authors.affiliation: Department of Orthopaedic Surgery, University of Utah, 590 Wakara Way, Salt Lake City, UT 84108.
authors.forename: Michael Q
authors.initials: MQ
authors.lastname: Potter
authors.affiliation: Department of Orthopaedic Surgery, University of Utah, 590 Wakara Way, Salt Lake City, UT 84108.
authors.forename: Travis G
authors.initials: TG
authors.lastname: Maak
authors.affiliation: Department of Population Health Sciences and Internal Medicine, University of Utah, 295 Chipeta Way, Salt Lake City, UT 84108.
authors.forename: Thomas H
authors.initials: TH
authors.lastname: Greene
authors.affiliation: Department of Orthopaedic Surgery, University of Utah, 590 Wakara Way, Salt Lake City, UT 84108. Stephen.Aoki@hsc.utah.edu.
authors.forename: Stephen K
authors.initials: SK
authors.lastname: Aoki
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use*; D001182:Arthroscopy; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D057925:Femoracetabular Impingement / Q000601:surgery*; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009288:Naproxen / Q000627:therapeutic use*; D009999:Ossification, Heterotopic / Q000209:etiology / Q000517:prevention & control*; D011183:Postoperative Complications / Q000517:prevention & control*; D011300:Preoperative Care / Q000379:methods*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D009288:Naproxen