Cryoneurolysis for TKA - a Pilot Study

• Status: Not yet recruiting
• Trial end date: 2023-05-01
• Target enrollment: 0
• Participant gender: All

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 knee replacement feel pain that lasts for at least 3 months after surgery and thus continue to take pain control/ analgesic (opioids) medication. Opiates are medications like morphine.

Pain post-surgery can make it difficult to recover and return to daily activities. A better control of pain before the surgery, can help people feel less pain, recover faster, and use less opioids after surgery.

Cryoneurolysis means freezing the nerves that can cause pain. It uses very low temperatures in a specific body part (e.g., nerves to the knee) to freeze the pain nerves and therefore reduce the pain. When applied before the surgery it might help with postoperative pain after knee replacement.

This study will evaluate Iovera, a cryoneurolysis handheld device commercially available in Canada that delivers freezing cold to a target nerve by using nitrous oxide. Cryoneurolysis can relieve pain and symptoms associated with osteoarthritis of the knee for up to 90 days.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Unity Health Toronto
• Treatments: Anesthetics; Anesthetics, Local

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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