Cryoneurolysis in Patients Awaiting Total Hip and Knee Arthroplasty
Launched by UNIVERSITY OF CALGARY · Apr 16, 2025
Trial Information
Current as of July 21, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is exploring a new approach to help manage pain for patients waiting for hip or knee replacement surgeries, known as total hip arthroplasty (THA) and total knee arthroplasty (TKA). Due to delays caused by the COVID-19 pandemic, many patients are facing long wait times, which can lead to increased pain and the need for strong pain medications like opioids. This study will look at a method called cryoneurolysis, which uses very cold temperatures to disrupt pain signals from specific nerves. The goal is to see if this treatment can help reduce pain and reliance on opioids for patients awaiting their surgery.
To participate in the trial, you must be over 18 years old, currently waiting for THA or TKA due to osteoarthritis, and taking daily opioids for at least a month. You should also be able to travel to the hospital for treatments and follow-up appointments. The study will involve 30 participants, with 15 from each surgery group, who will receive cryoneurolysis to help manage their pain while they wait. If you qualify and choose to participate, you can expect to receive this treatment as a way to improve your comfort before surgery, potentially reducing the need for stronger pain medications.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Currently awaiting THA or TKA (have signed consent for surgery)
- • Osteoarthritis as a primary diagnosis for THA or TKA
- • Currently taking regular daily opioids for at least one month
- • No allergies to local aesthetics
- • Speaks and understands English
- • Over 18 years old
- • Lives within a 1-hour distance of the hospital where the study is taking place or willing to travel to the hospital for the interventions and follow up.
- Exclusion Criteria:
- • If surgery is expected to be completed within 1 month of the intervention as this would limit our ability to evaluate the effectiveness of the cryoneurolysis procedure
- • Allergies to local anesthetics
- • Inability to communicate with investigators
- • Opioid use disorder
- • History of severe psychiatric or medical conditions which hinder effective communication
- • Living more than 1 hour away from the hospital where the study is taking place or unable to travel to the hospital for the interventions and follow up
- • Body mass Index (BMI) ≥40
- • Any contraindications specific to percutaneous cryoneurolysis such as history of bleeding diathesis, any active infections at the procedural site, cold urticaria, cryofibrinogenemia, cryoglobulinemia, paroxysmal cold hemoglobinuria, or Raynaud's disease (see Ilfeld \& Finneran, 2020)
- • Use of therapeutic anticoagulation
- • Diagnosis of Non-Osteoarthritis as the cause for THA or TKA
- • Other chronic pain condition which patients may be taking opioids to control the pain (e.g. Fibromyalgia or Complex Regional Pain Syndrome)
- • Less than 50% reduction in pain with diagnostic blocks using 0.5% bupivacaine
About University Of Calgary
The University of Calgary is a leading research institution dedicated to advancing health and science through innovative clinical trials. With a strong emphasis on multidisciplinary collaboration, the university's clinical research initiatives aim to address pressing health challenges and improve patient outcomes. The institution fosters a robust environment for academic inquiry, leveraging state-of-the-art facilities and a diverse network of experts in various fields. Committed to ethical research practices and community engagement, the University of Calgary strives to translate scientific discoveries into tangible benefits for society.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Trial Officials
Ryan Endersby, MD
Principal Investigator
University of Calgary
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported