iovera° Clinical data summary

iovera° knee osteoarthritis study

Lorem ipsum dolor sit amet consectetur adipisicing elit. Inventore eius aut unde maxime laborum ut accusantium nulla voluptates quia in, libero, hic placeat odit adipisci et eum id earum vero.

Study overview

  • 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

Methods

  • Treatment of the ISN only
  • Patients were followed through 120 days

Results

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 palpitation and swelling.


Retrospective total knee
arthroplasty (TKA) study

Study overview

  • 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

Methods

  • Treatment of the ISN only
  • Patients were followed through 120 days

Results

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 palpitation and swelling.

Reversible
1st Degree
Neuropraxia – interruption of conduction; Short recovery time
+10°C to -20°C
1st Degree
Neuropraxia – interruption of conduction; Short recovery time
+10°C to -20°C
Non Reversible
3rd/4th Degree
Neurotmesis – Loss of continuity; some loss of continuity of epineurium and perineurium; endoneurium may or may not be disrupted (liquid nitrogen)
-140°C and colder
Not possible with the iovera°
1st Degree
Neuropraxia – interruption of conduction; Short recovery time
+10°C to -20°C

Download PDF

Knappar outlinade

Lorem ipsum dolor sit amet consectetur adipisicing elit. Laborum, tempore officia. Rerum quis tenetur, culpa deleniti ducimus eum est error corporis accusantium veritatis numquam eius recusandae aliquam odio qui suscipit!

 

Knappar outlinade

Lorem ipsum dolor sit amet consectetur adipisicing elit. Laborum, tempore officia. Rerum quis tenetur, culpa deleniti ducimus eum est error corporis accusantium veritatis numquam eius recusandae aliquam odio qui suscipit!

References
1. Radnovich R, Scott D, Patel AT, et al. Cryoneurolysis to treat the pain and symptoms of knee osteoarthritis: a multicenter, randomized, double-blind, sham-controlled trial. Osteoarthritis Cartilage. 2017;25(8):1247-1256.
2. Hsu M, Stevenson FF. Wallerian degeneration and recovery of motor nerves after multiple focused cold therapies. Muscle Nerve. 2015;51(2):268-275.
3. Sunderland S. A classification of peripheral nerve injuries producing loss of function. Brain. 1951;74(4):491-516.
4. Sunderland S. Nerves and Nerve Injuries. London, United Kingdom: Churchill Livingstone; 1968:180.
5. Seddon HJ. Three types of nerve injury. Brain. 1943;66(4):237-288.
6. Ilfeld BM, Preciado J, Trescot AM. Novel cryoneurolysis device for the treatment of sensory and motor peripheral nerves. Expert Rev Med Devices. 2016;13(8):713-725.
7. Evans PJ. Cryoanalgesia: the application of low temperatures to nerves to produce anaesthesia or analgesia. Anaesthesia. 1981;36(11):1003-1013.