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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months postoperative
Awards & highlights
Study Summary
This trial is testing a handheld device to freeze nerves and relieve pain before knee replacement surgery in order to reduce post-surgery pain and opioid use.
Eligible Conditions
- Osteoarthritis
- Chronic Knee Pain
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months postoperative
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months postoperative
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Patient recruitment rate
Secondary outcome measures
EQ-5D-5L
Numeric Rating Scale of Pain
Opioid consumption
+2 moreTrial Design
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.
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Who is running the clinical trial?
Unity Health TorontoLead Sponsor
545 Previous Clinical Trials
450,452 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility 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.You must be between 18 and 80 years old.You are having surgery to replace your entire knee on one side.You have severe osteoarthritis in your knee that requires a total knee replacement, as confirmed by X-ray or other medical tests.
Research Study Groups:
This trial has the following groups:- Group 1: Iovera
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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