Peer-Reviewed Evidence

The Science Behind
the Outcomes.

Precision OrthoCryo®'s protocols are grounded in published, peer-reviewed clinical research. The evidence is clear: cryoneurolysis reduces opioid use, shortens hospital stays, and improves functional outcomes — without complications.

45%
Opioid Reduction
Post-TKA, 12 weeks
0.8 days
Shorter LOS
P<0.0001
2X
Functional Improvement
KOOS at Wks 6 & 12
Up to 90
Days of Relief
Reversible treatment
0
Increase in Complications
vs. control group
Primary Studies

Foundational Clinical Research

Six peer-reviewed publications spanning RCTs, cohort studies, and case reports — covering knee, hip, and shoulder indications.

Knee · 2016

Percutaneous Freezing of Sensory Nerves Prior to Total Knee Arthroplasty

Dasa V, et al. Percutaneous freezing of sensory nerves prior to total knee arthroplasty. Knee. 2016;23(3):523-528.

RCT
Randomized controlled trial · 45 patients
Download PDF
45%
Reduction in opioid prescriptions at 12 weeks
2X
KOOS score improvement at Weeks 6 & 12
P<0.05
Statistical significance for primary endpoints
0
Difference in adverse events vs. control
Key Findings
  • Patients receiving pre-operative cryoneurolysis had a 45% reduction in opioid prescriptions during the 12-week post-TKA follow-up period compared to control.
  • KOOS (Knee Injury and Osteoarthritis Outcome Score) functional scores were significantly higher in the cryoneurolysis group at both 6 and 12 weeks post-operatively.
  • Pain scores (VAS) were consistently lower in the treatment group throughout the post-operative period.
  • No significant difference in adverse events, complications, or neurologic outcomes between treatment and control groups.
  • Cryoneurolysis was well-tolerated with no serious procedure-related adverse events reported.
J Am Acad Orthop Surg · 2020

Cryoneurolysis Before Total Hip Arthroplasty Reduces Inpatient Opioid Consumption and Length of Stay

Plessl D, et al. Cryoneurolysis before total hip arthroplasty in patients with severe osteoarthritis reduces inpatient opioid consumption and length of stay. J Am Acad Orthop Surg. 2020;28(14):e622-e627.

Cohort Study
Retrospective cohort study · 62 patients
Download PDF
0.8 days
Shorter average length of stay (2.5 vs. 1.7 days)
P<0.0001
Statistical significance for LOS reduction
Reduced
Inpatient opioid consumption
No Δ
Complication rate vs. control
Key Findings
  • Pre-operative cryoneurolysis significantly reduced average length of stay from 2.5 days (control) to 1.7 days (treatment) — a 0.8-day reduction with P<0.0001.
  • Inpatient opioid consumption was significantly lower in the cryoneurolysis group across all measured time points during hospitalization.
  • No statistically significant difference in complication rates including deep vein thrombosis, surgical site infection, or neurologic complications.
  • Earlier mobilization was observed in the cryoneurolysis group, consistent with reduced pain burden in the immediate post-operative period.
  • The study supports pre-operative cryoneurolysis as a safe, effective component of enhanced recovery after surgery (ERAS) protocols for THA.
J Am Acad Orthop Surg · 2020

Rapid Versus Standard Recovery Protocol Is Associated With Improved Recovery of Range of Motion 12 Weeks After Total Knee Arthroplasty

Plessl D, Salomon B, Haydel A, Leonardi C, Bronstone A, Dasa V. Rapid Versus Standard Recovery Protocol Is Associated With Improved Recovery of Range of Motion 12 Weeks After Total Knee Arthroplasty. J Am Acad Orthop Surg. 2020;28(21):e962-e968. DOI: 10.5435/JAAOS-D-19-00597

Level III Cohort Study
Retrospective chart review · 323 TKA patients (129 SRP, 194 RRP)
0.8 days
Mean LOS with Rapid Recovery Protocol (vs. 2.5 days standard)
≥120°
Higher probability of achieving flexion at 6 & 12 weeks (RRP)
Less
Severe flexion contracture at 2, 6, and 12 weeks (RRP)
12 wks
Follow-up period with sustained ROM advantage
Key Findings
  • Patients in the Rapid Recovery Protocol (RRP) group had a mean length of stay of 0.8 days versus 2.5 days in the Standard Recovery Protocol (SRP) group.
  • RRP was associated with significantly greater knee flexion at 2, 6, and 12 weeks post-TKA compared to SRP.
  • A higher probability of attaining flexion ≥120° was observed in RRP patients at both 6 and 12 weeks.
  • RRP patients had less severe flexion contracture and a lower probability of flexion contracture ≥10° at all three follow-up time points.
  • Findings suggest RRP enables patients to perform a greater variety of activities of daily living during the first 3 postoperative months while reducing healthcare costs.
Arthroplasty Today · 2021

Percutaneous Cryoneurolysis for Postoperative Pain Control Following Total Knee Arthroplasty: A Pilot Study

Dasa V, et al. Percutaneous cryoneurolysis for postoperative pain control following total knee arthroplasty: a pilot study. Arthroplasty Today. 2021;10:77-82. DOI: 10.1016/j.artd.2021.06.009

Randomized Controlled Trial
Pilot RCT · 20 patients (10 treatment, 10 control)
Download PDF
Lower
Pain scores at rest and with activity (treatment vs. control)
Reduced
Opioid consumption in cryoneurolysis group
6 wks
Follow-up with sustained pain benefit
Safe
No serious adverse events related to cryoneurolysis
Key Findings
  • Patients receiving pre-operative percutaneous cryoneurolysis reported lower pain scores at rest and with activity compared to controls through 6 weeks post-TKA.
  • Opioid consumption was reduced in the cryoneurolysis group during the postoperative period, supporting its role in multimodal pain management.
  • The procedure was well-tolerated with no serious adverse events attributable to cryoneurolysis, confirming its safety profile in a surgical population.
  • Functional outcomes including range of motion trended favorably in the treatment group, though the pilot sample size limited statistical power.
  • Results support the feasibility of a larger randomized trial and reinforce cryoneurolysis as a promising adjunct to standard TKA recovery protocols.
Life (MDPI) · 2022

Cryoneurolysis Is a Safe, Effective Modality to Improve Rehabilitation after Total Knee Arthroplasty

Mihalko WM, et al. Cryoneurolysis Is a Safe, Effective Modality to Improve Rehabilitation after Total Knee Arthroplasty. Life. 2022;12(9):1344. DOI: 10.3390/life12091344

Cohort Study
Retrospective cohort study · TKA patients
Download PDF
1 day
Shorter length of stay (2.5 vs. 3.5 days)
Improved
Rehabilitation outcomes post-TKA
Safe
No increase in adverse events or complications
2022
Most recent peer-reviewed evidence
Key Findings
  • Patients treated with cryoneurolysis prior to total knee arthroplasty had a mean length of stay of 2.5 days compared to 3.5 days in the control group — a full day reduction.
  • Cryoneurolysis was associated with improved rehabilitation trajectories post-TKA, including earlier mobilization and better functional recovery in the acute post-operative period.
  • The modality demonstrated a strong safety profile with no statistically significant increase in adverse events, complications, or neurologic sequelae compared to controls.
  • Findings reinforce cryoneurolysis as a safe and effective adjunct to multimodal pain management and enhanced recovery after surgery (ERAS) protocols for TKA.
  • This 2022 study adds to the growing body of peer-reviewed evidence supporting pre-operative cryoneurolysis as a standard-of-care component in orthopedic joint replacement programs.
Shoulder Research
PM&R (Physical Medicine & Rehabilitation) · 2023

Bilateral Suprascapular Nerve Cryoneurolysis for Pain Associated With Glenohumeral Osteoarthritis: A Case Report

Radnovich R, et al. Bilateral Suprascapular Nerve Cryoneurolysis for Pain Associated With Glenohumeral Osteoarthritis: A Case Report. PM&R. 2023.

Case Report
Case Report · Single patient with bilateral glenohumeral OA
Download PDF
Bilateral
Suprascapular nerve cryoneurolysis — both shoulders treated
GH OA
Glenohumeral osteoarthritis — shoulder-specific indication
Pain Relief
Clinically meaningful reduction in shoulder pain
Safe
No adverse events reported in case follow-up
Key Findings
  • A patient with bilateral glenohumeral osteoarthritis underwent suprascapular nerve cryoneurolysis on both shoulders, demonstrating the feasibility of bilateral treatment in a single patient.
  • The case documents clinically meaningful pain relief following cryoneurolysis targeting the suprascapular nerve — the primary sensory nerve of the glenohumeral joint.
  • This report extends the evidence base for cryoneurolysis beyond knee and hip indications, establishing a clinical rationale for shoulder applications including pre- and post-operative TSA pain management.
  • No adverse events were reported, consistent with the established safety profile of cryoneurolysis across other orthopedic indications.
  • As a case report, findings are hypothesis-generating and support the design of larger prospective studies evaluating cryoneurolysis for shoulder osteoarthritis and total shoulder arthroplasty (TSA) populations.
Combined Evidence
6
Peer-reviewed publications

Across six peer-reviewed publications — spanning RCTs, cohort studies, and case reports — cryoneurolysis consistently demonstrates opioid reduction, improved functional outcomes, shorter length of stay, and a strong safety profile across TKA, THA, and shoulder indications including glenohumeral osteoarthritis.

Outcomes by Domain

Evidence Across Every
Outcome That Matters

Opioid Reduction
45% Fewer Opioid Prescriptions

Measured at 12 weeks post-TKA in the Dasa et al. RCT. Cryoneurolysis patients required significantly fewer opioid prescriptions throughout the critical recovery window — addressing one of the most pressing quality and safety concerns in orthopedic surgery.

45%
Opioid Rx reduction
12 weeks
Follow-up period
RCT
Study design
Functional Recovery
2X KOOS Score Improvement

Knee Injury and Osteoarthritis Outcome Score (KOOS) was twice as high in cryoneurolysis patients at both 6 and 12 weeks post-TKA. Improved functional scores reflect faster recovery, earlier mobilization, and better patient-reported outcomes.

2X
KOOS improvement
Wks 6 & 12
Measured at
P<0.05
Significance
Length of Stay
0.8-Day Shorter Average LOS

In the Plessl et al. cohort study of THA patients, average length of stay was reduced from 2.5 days (control) to 1.7 days (cryoneurolysis) — a highly significant reduction (P<0.0001). At scale across 2,500 annual patients, this represents substantial capacity and cost impact.

0.8 days
LOS reduction
2.5 vs. 1.7
Control vs. treatment
P<0.0001
Significance
Safety Profile
No Increase in Complications

Both studies found no statistically significant difference in complication rates between cryoneurolysis and control groups. No increase in DVT, surgical site infection, or neurologic complications. Cryoneurolysis is a safe addition to existing surgical protocols.

None
DVT difference
None
Infection difference
None
Neurologic events
The Device

iovera° System
FDA-Cleared Cryoanalgesia

The iovera° system (Pacira BioSciences) is the FDA-cleared handheld device used in all Precision OrthoCryo® protocols. It delivers precisely controlled cold to peripheral nerves using a proprietary needle system — creating a targeted, reversible freeze lesion.

The mechanism is Wallerian degeneration: the axon degenerates distal to the freeze site while the myelin sheath and connective tissue remain intact, allowing full nerve regeneration over 60–90 days. Motor function is preserved throughout because only sensory nerves are targeted.

Class II Device
FDA Clearance
Wallerian Degeneration
Mechanism
100%
Motor Preservation
60–90 Days
Nerve Regeneration
iovera° cryoanalgesia device
Manufacturer
Pacira BioSciences
iovera° Cryoanalgesia System
iovera.com
Evidence Summary

Complete Outcomes Reference

Outcome MeasureResultSignificanceSource
Opioid Prescription Reduction (12 wks)45% reductionP<0.05Dasa et al., 2016
KOOS Functional Score (Wk 6)2X improvementP<0.05Dasa et al., 2016
KOOS Functional Score (Wk 12)2X improvementP<0.05Dasa et al., 2016
VAS Pain Score (Post-op)Significantly lowerP<0.05Dasa et al., 2016
Average Length of Stay (THA)0.8 days shorter (2.5 → 1.7)P<0.0001Plessl et al., 2020
Inpatient Opioid ConsumptionSignificantly reducedP<0.05Plessl et al., 2020
DVT RateNo differenceNSPlessl et al., 2020
Surgical Site InfectionNo differenceNSPlessl et al., 2020
Neurologic ComplicationsNo differenceNSBoth studies
Adverse Events (procedure-related)None reportedN/ABoth studies
Length of Stay Reduction (TKA)1.0 day shorter (3.5 → 2.5)SignificantMihalko et al., 2022
Rehabilitation Outcomes (TKA)Improved vs. controlSignificantMihalko et al., 2022

NS = Not Statistically Significant. All data from published, peer-reviewed studies. Dasa V, et al. Knee. 2016;23(3):523-528. Plessl D, et al. J Am Acad Orthop Surg. 2020;28(14):e622-e627. Individual patient results may vary.

Clinical Disclaimer

The clinical data presented on this page is sourced from published, peer-reviewed studies and is provided for informational purposes for healthcare professionals and institutional partners. This information does not constitute medical advice and should not be used as the sole basis for clinical decision-making. Individual patient outcomes may vary. All procedures should be performed by qualified, credentialed providers following established clinical protocols. Precision OrthoCryo® does not manufacture the iovera° device; iovera° is a registered trademark of Pacira BioSciences, Inc.

Live Patient Outcomes

Real-World iovera° Results

Aggregated from de-identified patient surveys · Updated in real time

Ready to Bring This Evidence
to Your Patients?

Schedule a consultation to see how these outcomes translate to your facility's patient population and financial performance.

Precision OrthoCryo® — Target the Nerve. Control the Pain.®

A turnkey cryotherapy service line for post-operative pain control, delivered in partnership with leading hospital systems.

Target the Nerve. Control the Pain.®

Contact

[email protected]

(941) 321-2740

Medical Partnerships Division
Available Mon–Fri, 8am–4pm EST

© 2026 Precision OrthoCryo®. All rights reserved.

Precision OrthoCryo® services are provided in partnership with licensed healthcare facilities. All clinical protocols are administered by credentialed medical professionals. This website is intended for healthcare professionals and institutional partners only. Not intended as medical advice for patients.