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Effect of Naproxen Prophylaxis on Heterotopic Ossification Following Hip Arthroscopy: A Double-Blind Randomized Placebo-Controlled Trial.

ABSTRACT: 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.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.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).In this trial, prophylaxis with naproxen was effective in reducing the prevalence of HO without medication-related morbidity.

SUBMITTER: Beckmann JT

PROVIDER: S-EPMC4673445 | biostudies-literature | 2015 Dec

REPOSITORIES: biostudies-literature

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Effect of Naproxen Prophylaxis on Heterotopic Ossification Following Hip Arthroscopy: A Double-Blind Randomized Placebo-Controlled Trial.

Beckmann James T JT Wylie James D JD Potter Michael Q MQ Maak Travis G TG Greene Thomas H TH Aoki Stephen K SK

The Journal of bone and joint surgery. American volume 20151201 24

<h4>Background</h4>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.<h4>Methods</h4>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 sur ...[more]

PMID: 26677237

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Project description:CONTEXT: Rehabilitation following hip arthroscopy is an integral component of the clinical outcome of the procedure. Given the increase in quantity, complexity, and diversity of procedures performed, a need exists to define the role of rehabilitation following hip arthroscopy. OBJECTIVES: (1) To determine the current rehabilitation protocols utilized following hip arthroscopy in the current literature, (2) to determine if clinical outcomes are significantly different based on different post-operative rehabilitation protocols, and (3) to propose the best-available evidence-based rehabilitation program following hip arthroscopy. DATA SOURCES: Per PRISMA guidelines and checklist, Medline, SciVerse Scopus, SportDiscus, and Cochrane Central Register of Controlled Trials were searched. STUDY SELECTION: Level I-IV evidence clinical studies with minimum 2-year follow-up reporting outcomes of hip arthroscopy with post-operative rehabilitation protocols described were included. DATA EXTRACTION: All study, subject, and surgery parameters were collected. All elements of rehabilitation were extracted and analyzed. Descriptive statistics were calculated. Study methodological quality was analyzed using the modified Coleman methodology score. RESULTS: Eighteen studies were included (2,092 subjects; 52% male, mean age 35.1 ± 10.6 years, mean follow-up 3.2 ± 1.0 years). Labral tear and femoroacetabular impingement were the most common diagnoses treated and labral debridement and femoral/acetabular osteochondroplasty the most common surgical techniques performed. Rehabilitation protocol parameters (weight-bearing, motion, strengthening, and return to sport) were poorly reported. Differences in clinical outcomes were unable to be assessed given heterogeneity in study reporting. Time-, phase-, goal-, and precaution-based guidelines were extracted and reported. CONCLUSION: The current literature of hip arthroscopy rehabilitation lacks high-quality evidence to support a specific protocol. Heterogeneity in study, subject, and surgical demographics precluded assimilation of protocols and/or outcomes to generate evidence-based guidelines. Strengths and limitations in the literature were identified. Future studies should recognize and report the essentials of rehabilitation following hip arthroscopy.

Dataset Information

Effect of Naproxen Prophylaxis on Heterotopic Ossification Following Hip Arthroscopy: A Double-Blind Randomized Placebo-Controlled Trial.

Publications

Effect of Naproxen Prophylaxis on Heterotopic Ossification Following Hip Arthroscopy: A Double-Blind Randomized Placebo-Controlled Trial.

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