iovera° Clinical data summary

The clinical value of iovera has been established in two high unmet need settings of knee osteoarthritis and total knee arthroplasty, respectively.

iovera° knee osteoarthritis study

Study overview1

  • Randomised, multicentre, prospective, sham-controlled, double-blind study
  • 17 sites across the United States
  • N=180 (randomised 2:1)
  • Treatment Group = 121 subjects treated with iovera°
  • Control Group = 59 subjects treated with a sham tip

Methods1

  • Treatment of the infrapatellar branch of the saphenous nerve (ISN) only
  • Patients were followed through 120 days post-treatment

Results1

The iovera° group demonstrated a statistically significant greater change from baseline in the WOMAC Total score than the sham group at Days 30 (P=0.0010) and 90 (P=0.0108). The most common side effects were bruising, numbness, redness, tenderness upon palpation and swelling.



Retrospective total knee arthroplasty (TKA) study

Study overview2

  • Single site (Louisiana State University Health Sciences, School of Medicine); retrospective chart review; N=100
  • Treatment Group = First 50 patients treated after iovera° introduced
  • Control Group = Last 50 patients treated before iovera° introduced

Methods2

iovera° treatment of the infrapatellar branch of the saphenous nerve (ISN) and anterior femoral cutaneous nerve (AFCN) 5 days prior to TKA

Results for the iovera° group2

  • Required 45% less opioids than the control group during the 12 weeks after surgery based on prescription requests P<0.0001
  • Compared to the control group, the iovera° treatment group demonstrated significantly greater improvement in knee injury and osteoarthritis outcome score (KOOS) symptoms scores at 6 weeks and 12 weeks post surgery
  • The iovera° group demonstrated within-group significant reductions in PROMIS® pain intensity and pain interference at 2- and 6-week follow-up, respectively (P<0.0001)
  • Significantly fewer iovera° patients (6%) had a length of stay of ≥2 days compared with the control group (67%), P<0.0001
  • The most common side effect was local bruising at the site of treatment


*P value not reported. WOMAC = Western Ontario & McMaster Universities Osteoarthritis Index
KOOS=Knee Injury and Osteoarthritis Outcome Score; PROMIS=Patient-Reported Outcomes Measurement Information System.

References
1. Radnovich R, et al. Osteoarthritis Cartilage. 2017;25(8):1247-1256;
2. Dasa V, et al. Knee. 2016;23(3):523-528;