20 Participants Needed

Cryoneurolysis for Knee Pain

AA
LM
Overseen ByLuana Melo
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Unity Health Toronto

Trial Summary

Do I need to stop my current medications for the trial?

The trial requires that you are not currently using opioids. If you are taking opioids, you would need to stop before participating.

What data supports the effectiveness of the treatment Iovera - Cryoneurolysis for knee pain?

Research shows that cryoneurolysis can effectively reduce pain and symptoms in knee osteoarthritis, and it has been used to manage pain after knee surgery. It works by using cold temperatures to temporarily block nerve signals, providing pain relief for weeks or months.12345

How does the treatment Iovera - Cryoneurolysis for knee pain differ from other treatments?

Cryoneurolysis is unique because it uses freezing temperatures to temporarily block nerve signals, providing pain relief for weeks to months without permanent nerve damage. This method is different from other treatments like local anesthetic nerve blocks, which typically offer shorter-term relief.12346

What is the purpose of this trial?

This trial is testing a device called Iovera that freezes pain-causing nerves to help people who are having knee replacement surgery. The goal is to reduce pain and the need for opioid medications after surgery. The study will see if this method can make recovery easier and faster.

Eligibility Criteria

Inclusion Criteria

Both male and female patients can participate.
You have not received an injection in one of your knees with steroids or biologics in the last 6 months.
You are able to read and understand English and give permission to participate in the study with full knowledge of what it entails.
See 2 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Treatment

Participants receive cryoneurolysis treatment using the Iovera device or placebo prior to surgery

1 day
1 visit (in-person)

Postoperative Follow-up

Participants are monitored for pain management, function, and opioid consumption

12 weeks
Multiple visits (in-person and virtual) at 2, 6, and 12 weeks

Treatment Details

Interventions

  • Iovera - Cryoneurolysis
  • Local anesthetic
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: IoveraExperimental Treatment1 Intervention
Cryoneurolysis + standard of care: Usual intervention plus pre-operation Iovera treatment. Patients will receive local anaesthesia unilaterally to the affected knee prior to the treatment and then the anesthesiologist will administer the freezing cold therapy (Iovera device) to the affected knee.
Group II: PlaceboPlacebo Group1 Intervention
Placebo: Usual intervention plus pre-operation placebo. The placebo group will receive short-acting local anaesthesia injection unilaterally to the affected knee.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Unity Health Toronto

Lead Sponsor

Trials
572
Recruited
470,000+

References

Cryoneurolysis to treat the pain and symptoms of knee osteoarthritis: a multicenter, randomized, double-blind, sham-controlled trial. [2018]
Cooled radiofrequency ablation versus cryoneurolysis of the genicular nerves for the symptomatic pain management in knee osteoarthritis: a study protocol of a prospective, randomized, single-blinded clinical trial. [2023]
An open-label, single-arm trial of cryoneurolysis for improvements in pain, activities of daily living and quality of life in patients with symptomatic ankle osteoarthritis. [2022]
A Randomized Controlled Pilot Study Using Ultrasound-Guided Percutaneous Cryoneurolysis of the Infrapatellar Branch of the Saphenous Nerve for Analgesia Following Total Knee Arthroplasty. [2023]
Cryoneurolysis with Injectable Ice Slurry Modulates Mechanical Skin Pain. [2023]
Body Habitus Impact on Success of Cryoneurolysis for Postoperative Total Knee Arthroplasty Pain Control: A Retrospective Cohort Study. [2023]
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