Cryoneurolysis for Acute Postoperative Pain Following Total Knee Arthroplasty

Launched by COPENHAGEN UNIVERSITY HOSPITAL, HVIDOVRE · Oct 12, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called cryoneurolysis, which is a technique that freezes certain nerves to help reduce pain after total knee replacement surgery (also known as total knee arthroplasty). The goal of the study is to see if this freezing technique can provide better pain relief compared to a placebo (a sham treatment) for patients who are experiencing moderate to severe pain the day after their surgery. Participants will receive the treatment 24 hours after their surgery and will be monitored for up to 24 weeks to track their pain levels and overall recovery.

To be eligible for the trial, participants must be at least 18 years old, have had a total knee replacement on one knee, and be able to understand Danish to report their pain and satisfaction. They also need to have significant pain measured by a specific scale during a short walking test after surgery. However, certain people won't be able to participate, including those with certain medical conditions (like ongoing infections or severe mental health issues), those who are pregnant or breastfeeding, and those with specific types of pain conditions. If you decide to join the study, you can expect to receive either the cryoneurolysis treatment or the placebo, and the research team will be there to support you throughout the process.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age ≥ 18
• • Primary unilateral total knee arthroplasty
• • Ability to participate in the study (understand written and spoken Danish language, self-reported pain and satisfaction)
• • Signed written informed consent form
• • Pain (VAS 0-100 mm) ≥ 45 during a 5-meter walk test at 24 h (20-28h) postoperatively
• Exclusion Criteria:
• • Ongoing treatment of systemic glucocorticoids or other immunosuppressant treatment apart from inhaled steroids
• • Insulin-dependent diabetes
• • Pregnancy or breastfeeding
• • Mental disability that could impair a patient's decision-making capability of giving informed consent and not enabling valid data collection.
• • Patients with known diagnoses of schizophrenia, ongoing psychosis, bipolar disease and/or a history of ongoing anti-psychotic treatment.
• • Patients with modulated pain-reception (experience) based on other diseases or injuries, e.g. spinal cord or brain injury, severe polyneuropathies or neurologic disorders.
• • Posttraumatic osteoarthritis as reason for total knee arthroplasty
• • Bleeding disorder
• • Localized infection in the treatment area
• • Cryoglobulinemia, cold urticaria, paroxysmal cold haemoglobinuria, or Raynaud's syndrome
• • Perioperative peripheral nerve block