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

SLR - June 2016 - Caroline Kiser

Reference: Beckman JT, Wylie JD, Potter MQ, Maak TG, Greene TH, Aoki SK. Effect of Naproxen Prophylaxis on Heterotopic Ossification Following Hip Arthroscopy: A Double-Blind Randomized Placebo-Controlled Trial. J Bone Joint Surg Am. 2015 Dec 16:97(24):2032–2037.

Scientific Literature Review

Reviewed By: Caroline Kiser, DPM
Residency Program: Wheaton Franciscan Healthcare-St. Joseph, Milwaukee, WI

Podiatric Relevance: The use of multimodal analgesia for postoperative pain management has been advocated as a means of reduction of opioid use in the postoperative and rehabilitative stages of healing. Nonsteroidal anti-inflammatories (NSAIDs) are effective in reducing postoperative pain as well as decreasing the need for narcotics. Multiple studies have investigated the correlation between NSAID use and bone healing. This study reports on the use of naproxen prophylaxis for the development of heterotrophic ossification (HO) following hip arthroscopy.

Methods: At one academic institution, 106 eligible patients were enrolled and randomized to take naproxen 500mg or placebo twice daily for three weeks following hip arthroscopy. The placebo group consisted of 54 patients and the naproxen group consisted of 52 patients. Standard hip arthroscopy was performed in all cases by a single surgeon with a high-volume hip arthroscopy practice. Radiographs were taken at routine post-operative appointments for one year following the surgery. All patients were supplied medication through a single pharmacy where computer generated randomized envelopes were delivered for medication preparation of either naproxen 500mg or placebo. Both preparations were labeled “Study Medication” prior to disbursement.  
Serial radiographs were reviewed by two orthopedic surgeons to determine the presence of HO. A musculoskeletal radiologist was enlisted in the event that they disagreed on the presence of HO as indicated by radiographs obtain 75 days postoperatively. Patients were instructed to bring medication to all postoperative visits to ensure compliance. Information related to NSAID-specific side effects including gastrointestinal upset, nausea, vomiting and gastrointestinal bleeding was obtained from all patients.

Results: A total of ninety-six patient were available for final follow-up. At the primary midterm follow-up, radiographic assessment of HO was 12/34 (35 percent) in the placebo group compared to 2/32 (6 percent) in the naproxen group. At final radiographic follow up the prevalence of HO was 22/48 (46 percent) in the placebo group and 2/48 (4 percent) in the naproxen group. Final radiographic assessment was taken at an average of 322 days with a minimum of 75 days.   

The frequency of medication-related adverse events by treatment group was not statistically significant between the two groups. There were 19 in the placebo group and 22 in the naproxen group who reported at least one adverse event from their reported medication.

Conclusions: The results of the reviewed study illustrate that naproxen use prophylactically does significantly reduce HO formation following hip arthroscopy. There was a 46 percent prevalence of HO in patients who did not take naproxen with a notable reduction to 4 percent when naproxen was taken prophylactically.

Overall, parallels can be drawn between the findings in this study and the complications seen with HO in total ankle arthroplasty. Currently, recommendations regarding prophylactic NSAID administration for total ankle arthroplasty are unavailable. The evidence presented in this article and in orthopaedic literature provides strong evidence for the routine use of NSAIDs in the appropriate patient. With these recommendations, foot and ankle surgeons should consider routine NSAID prophylaxis when there is concern for HO formation.