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)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 1 (1 locations)

1

St Michael's Hospital

Toronto, Ontario, Canada, M5B1W8