Retrospective total knee arthroplasty (TKA) study1
- Single site (Louisiana State University Health Sciences Center School of Medicine); retrospective review; N=100
- Treatment group = First 50 patients treated after iovera° introduced
- Control group = Last 50 patients treated before iovera° introduced
- iovera° treatment of the infrapatellar branch of the saphenous
- The iovera° group required 45% less opioids during the 12 weeks after surgery, based on prescription requests
- Compared with the control group, the iovera° group demonstrated a significantly greater improvement in KOOS symptom scores at 6 weeks and 12 weeks
- 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)
- The most common side effect was local bruising at the site of treatment
KOOS=Knee Injury and Osteoarthritis Outcome Score;
PROMIS=Patient-Reported Outcomes Measurement Information System.
*P value not reported.
Percutaneous freezing of sensory nerves prior to total knee arthroplasty
Prospective knee osteoarthritis (OA) study2
- Multicenter, prospective, sham-controlled, double-blind study
- 17 sites across the United States; N=180 (randomized 2:1)
- Treatment group = 121 subjects treated with iovera°
- Control group = 59 subjects treated with a sham tip
- Treatment of the ISN only
- Patients were followed through to 120 days
- The iovera° group demonstrated a significantly greater reduction in WOMAC pain score at Days 30, 60, and 90 (P<0.02)
- The most common side effects were bruising, numbness, redness, tenderness upon palpation, and swelling
WOMAC=Western Ontario and McMaster Osteoarthritis Index.
Cryoneurolysis to treat the pain and symptoms of knee osteoarthritis: a multicenter, randomized, double-blind, sham-controlled trial
Prospective Randomized TKA Clinical Study3
- Single site (Campbell Clinic)
- Prospective (N=124)
- 2 hospitals, 5 surgeons
- Randomized 1:1
- Control group=standard of care TKA
- Treatment group=iovera° 3 to 7 days prior to TKA
- Results for the iovera° group demonstrated both a reduction in opioid use and an improvement in KOOS symptom score with a per-protocol analysis, but not with an intent to treat analysis.
- Compared with the control group, a per protocol analysis showed the iovera° treatment group demonstrated significantly
- Lower opioid consumption at 72 hours, 6 weeks, and 12 weeks after discharge
- More opioid-free patients at 6 weeks after discharge
- Reduced KOOS scores from baseline to each follow-up assessment
- 34% less opioids were required 6 weeks after discharge (mean, 4.2 mg vs 5.9 mg; P=0.0186).
KOOS=Knee injury and Osteoarthritis Outcome Score.
Cryoneurolysis before total knee arthroplasty in patients with severe osteoarthritis for reduction of postoperative pain and opioid use in a single-center randomized controlled trial.
|Novel methodologies in regional anesthesia for knee arthroplasty. Gabriel RA, et al. Anesthesiology Clinics. 2018.|
|Although a single application of ultrasound-guided percutaneous cryoneurolysis provides weeks to months of analgesia, careful selection of candidates is required.4|
|Ultrasound-guided percutaneous cryoneurolysis for treatment of acute pain: could cryoanalgesia replace continuous peripheral nerve blocks? Ilfeld BM, et al. British Journal of Anaesthesia. 2017.|
|Concludes that “current evidence suggests that ultrasound-guided percutaneous cryoanalgesia holds enormous potential for making a dramatic leap forward in providing long-term analgesia, far surpassing typical continuous peripheral nerve blocks, with minimal risk and a lower patient burden.”5|
|Novel cryoneurolysis device for the treatment of sensory and motor peripheral nerves. Ilfeld BM, et al. Expert Review of Medical Devices. 2016.|
|Concludes that “changes in the US healthcare system such as a push for the reduction of opioid use and the incorporation of Diagnostic Related Group codes, as well as recent technological advances including a handheld unit that allows for treatment of superficial nerves while protecting the skin from damage, may contribute to the resurgence of cryoneurolysis for the treatment of peripheral nerves.”6|
|Wallerian degeneration and recovery of motor nerves after multiple focused cold therapies. Hsu M, et al. Muscle & Nerve. 2015.|
|There was consistent weakening of physiological function and restoration of normal function after each treatment. Low-temperature treatment of motor nerves did not result in permanent or long-term changes to nerve function or structure.7|
|Reduction in muscular motility by selective focused cold therapy: a preclinical study. Hsu M, et al. Journal of Neural Transmission. 2014.|
|Application of low temperatures to peripheral motor nerves resulted in temporary denervation and loss of function of the treated rat hind limb. Low-temperature treatment on motor nerves did not result in any permanent or long-term changes to function and structure of the nerves.8|
- Dasa V, Lensing G, Parsons M, Harris J, Volaufova J, Bliss R. Percutaneous freezing of sensory nerves prior to total knee arthroplasty. Knee. 2016;23(3):523-528.
- 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.
- Mihalko WM et al. J Arthroplasty. 2021;36(5):1590-1598.
- Gabriel RA, Ilfeld BM. Novel methodologies in regional anesthesia for knee arthroplasty. Anesthesiol Clin. 2018;36(3):387-401.
- Ilfeld BM, Gabriel RA, Trescot AM. Ultrasound-guided percutaneous cryoneurolysis for treatment of acute pain: could cryoanalgesia replace continuous peripheral nerve blocks? Br J Anaesth. 2017;119(4):703-706.
- 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.
- Hsu M, Stevenson FF. Wallerian degeneration and recovery of motor nerves after multiple focused cold therapies. Muscle Nerve. 2015;51(2):268-275.
- Hsu M, Stevenson FF. Reduction in muscular motility by selective focused cold therapy: a preclinical study. J Neural Transm (Vienna). 2014;121(1):15-20.