Status:
UNKNOWN
Cryoneurolysis for TKA - a Pilot Study
Lead Sponsor:
Unity Health Toronto
Conditions:
Knee Pain Chronic
Osteoarthritis
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
Total Knee Arthroplasty (TKA) is also known as a knee replacement. It is one of the most common orthopaedic (bone) surgeries performed and is usually very successful, but some people who have had a kn...
Detailed Description
Patients undergoing total knee replacement (TKA) often experience a significant amount of pain during the immediate postoperative period, thus appropriate pain management before, during and after the ...
Eligibility Criteria
Inclusion
- Male and female patients
- 18 to 80 years of age
- Patients with radiographic confirmation and clinical correlation for severe osteoarthritis diagnosis with an indication for total knee replacement
- Patients undergoing primary unilateral total knee replacement
- No previous unilateral knee injection (steroids/biologics) within 6 months of study
- The patient is able to read and understand English and provide informed consent to participation in the study
Exclusion
- Pregnancy and breastfeeding
- Cryoglobulinemia
- Paroxysmal cold hemoglobinuria
- Cold urticaria
- Raynaud's disease
- Current Opioid use
- History of opiate, narcotic and alcohol abuse
- Revision total knee replacement surgery
- Open and/or infected wounds at or near the affected knee
Key Trial Info
Start Date :
December 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05286996
Start Date
December 1 2022
End Date
December 1 2023
Last Update
May 12 2023
Active Locations (1)
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1
St Michael's Hospital
Toronto, Ontario, Canada, M5B1W8