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Long-Term Efficacy and Safety of Periarticular Hyaluronic Acid in Acute Ankle Sprain


Michael J. Petrella, PhD; Anthony Cogliano, MD; Robert J. Petrella, MD, PhD

Abstract: The objectives of this study were to determine the long-term efficacy and safety of periarticular hyaluronic acid injections in acute lateral ankle sprain. A randomized controlled prospective trial in a primary sport medicine and emergency practice involved 158 competitive athletes who suffered an acute Grade 1 or 2 lateral ankle sprain, and who were randomized within 48 hours of injury. Patients were randomized at baseline to periarticular injection with hyaluronic acid (HA) + standard of care (rest, ice, elevation, and compression [RICE]) or placebo injection (PL) + standard of care (RICE) treatment at baseline assessment and Day 4 post injury. Follow-up was at 30, 90, and 712 days post treatment. Assessments at baseline and Days 4, 8, 30, 90, and 712 included visual analog scale (VAS) (0–10 cm) pain on weight bearing and walking 20 m, patient global assessment of ankle injury (5-point categorical scale), patient satisfaction with treatment (5-point categorical scale), time to return to pain-free and disability-free sport, recurrent ankle sprain, total number of days missing from primary sport activity, and adverse events (AEs). Time to intervention was 39 ± 4 hours with no difference between groups. A significant reduction in VAS pain on both weight bearing and walking was observed at all follow-up assessments for HA compared with PL (P  0.001). Time to pain-free and disability-free return to sport was 11 (± 8) versus 17 (± 8) days for HA and PL, respectively (P  0.05). At 24 months, in the PL versus HA group, there were 2 versus 0 lower limb fractures, 16 versus 7 second ankle sprains (P  0.05), 3 versus 1 third ankle sprains, and a significantly greater number of days missing primary sport activity (41 versus 21; P  0.002). Significantly greater patient satisfaction was also observed for HA versus PL at all follow-up assessments. No serious AEs were recorded throughout follow-up. Periarticular HA treatment for acute ankle sprain was highly satisfactory in the short and long term versus PL. This was associated with reduced pain, more rapid return to sport, fewer recurrent ankle sprains, fewer missed days from sport, with few associated AEs to 24 months.
Keywords: ankle sprain; hyaluronic acid; long-term efficacy and safety

 

Periarticular Hyaluronic Acid in Acute Ankle Sprain


Robert J. Petrella, MD, PhD, Michael J. Petrella, PhD, and Anthony Cogliano, MD

Objectives: To determine the efficacy and safety of periarticular hyaluronic acid injections in acute lateral ankle sprain during 9 months at a sports injuries center.

Design: Randomized controlled prospective trial. Setting: Primary sport medicine and emergency practice.

Patients: One hundred fifty-eight consecutive competitive athletes who suffered acute grade 1 or 2 lateral ankle sprains were randomized within 48 hours of injury.

Interventions: Patients were randomized at baseline to periarticular injection with hyaluronic acid (HA) + standard of care [rest, ice, compression, and elevation (RICE)] or placebo injection (PL) + standard of care (RICE) treatment at baseline assessment and on day 4 after injury.

Outcomes measures: Assessments at baseline and days 4, 8, 30, and 90 included Visual Analogue Scale (VAS; 0–10 cm) pain on weight bearing and walking 20 m, patient global assessment of ankle injury (five-point categorical scale), patient satisfaction with treatment (five-point categorical scale), time to return to pain-free and disability-free sport, and adverse events. Differences between groups were determined using an intent-to-treat analysis of variance.

Results: About 30% of the ankle sprains were ‘‘first’’ events, and no differences in clinical assessments with those presenting but not volunteering for the study (n = 341) were observed. Time to intervention was 39 6 4 hours, with no difference between groups. No serious adverse events were recorded during the 8-day treatment period. No difference in concomitant treatment or physical therapy was observed between groups. A significant reduction in VAS pain on both weight bearing and walking was observed at day 8 for HA compared with PL (P , 0.05). Significantly greater patient satisfaction was observed for HAversus PL at days 4 (P , 0.05), 8 (P , 0.001), 30 (P , 0.001), and 90 (P , 0.05). Patient global assessment of ankle injury was significantly better compared with baseline in the HA group at day 8, but this was not different between groups. Time to pain-free and disability-free return to sport was 11 (6 8) versus 17 (6 8) days for HA and PL, respectively (P , 0.05).

Conclusion: HA treatment for acute ankle sprain was highly satisfactory in the short term and the long term versus PL. This was associated with reduced pain and more rapid return to sport, with few associated adverse events.

Key Words: ankle sprain, hyaluronic acid (Clin J Sport Med 2007;17:251–257)

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