Less pain, fewer opioids

2x

Significant pain reduction to help patients recover

2x the improvement in KOOS symptom score (vs control group) at both week 6 and week 12 post-TKA1,2

The iovera° group demonstrated significant reductions in PROMIS® pain intensity and pain interference at 2- and 6-week follow-up, respectively (P<0.0001)1

45%

Reduced reliance on opioids*

45% reduction in opioid consumption during the 12 weeks following surgery1

In this study, the most common side effect was bruising at the injection site1

Study Design: Retrospective chart review (N=100). Treatment group included first 50 patients treated with cryoneurolysis, plus multimodal treatment following its adoption in the practice for TKA. Control group was 50 patients treated with multimodal approach alone. Treatments were administered 5 days prior to the scheduled TKA.

Percutaneous freezing of sensory nerves
prior to total knee arthroplasty

Faster recovery of clinically meaningful rom3

At 6 weeks post-TKA

≥120°
Flexion attained
by 20% of patients

108°
Average flexion

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Recovery timeline icon

Improved
recovery of rom3

at Weeks 2, 6, and 12 post-TKA for early and sustained knee movement

Calendar scheduling icon

Demonstrated
shorter LOS3

(0.8 vs 2.5 days; P<0.0001)

Study Design: Retrospective chart review (N=323) of patients treated with standard recovery practice (n=129) and those with a rapid recovery protocol that included cryoneurolysis (n=194).

Rapid vs standard recovery protocol is associated with improved recovery of range of motion 12 weeks after total knee arthroplasty

Reduced opioid use and improved koos scores4

34%

  • 34% fewer opioids were required 6 weeks after discharge in a per-protocol analysis (mean, 4.2 mg vs 5.9 mg; P=0.0186)
    • Lower opioid consumption at Day 3 and 6 weeks through
      12 weeks after discharge
    • More opioid-free patients at 6 weeks after discharge
KOOS clinical outcomes chart mobile

Study Design: Single-site (N=124) prospective study of patients randomized 1:1 between a treatment group (iovera° 3 to 7 days prior to TKA) and a control group (standard of care TKA).

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

Fewer opioids, better range of motion, reduced length of stay5

Compared with the control group, the iovera° group demonstrated:

51%

51% lower adjusted mean daily opioid consumption

68%

68% reduction in total adjusted
mean opioid consumption

Adjusted clinical outcomes chart

Improved
Knee
Flexion

Significant knee flexion and extension at discharge5

  • 98% had flexion ≥90° vs 80% in the control group
  • 97% had extension ≤5° vs 79% in the control group

Shortened
Hospital
LOS

Significant reduction in overall hospital LOS5

  • Less than 1 of 5 (17%) of patients had an overall LOS ≥2 days vs nearly all (99%) of patients in the control group (P<0.0001)

Study Design: A single-site retrospective chart review of patients (N=267) undergoing an inpatient primary TKA with 169 subjects treated with iovera° (treatment group) and 98 subjects who did not receive cryoneurolysis (control group).

A multimodal pain management protocol including preoperative cryoneurolysis for total knee arthroplasty to reduce pain, opioid consumption, and length of stay

AAOS=American Academy of Orthopaedic Surgeons; AUC=area under the curve; KOOS JR=Knee Injury and Osteoarthritis Outcome Score Joint Replacement; LOS=length of stay; PROMIS=Patient-Reported Outcomes Measurement Survey; ROM=range of motion; TKA=total knee arthroplasty.

  • References:
  • 1. Dasa V et al. Knee. 2016;23(3):523-528.
  • 2. Data on file. Pacira BioSciences, Inc.; 2021.
  • 3. Plessl D et al. J Am Acad Orthop Surg 2020;28: e962-e968
  • 4. Mihalko WM et al. J Arthroplasty. 2021;36(5):1590-1598.
  • 5. Urban JA et al. Arthroplast Today. 2021;10:87-92.

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