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Cryoneurolysis Prior to Total Knee Arthroplasty

StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Minor Study completion pushed from Mar 1, 2026 to Dec 31, 2026
    • Eligibility criteria shortened, about 21 words
    • Secondary endpoints: details revised at 2 of 9 entries
    • Study description revised
  2. Notable Primary completion date changed from estimate of Dec 1, 2024 to Jun 1, 2025
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Aug 1, 2025 to Mar 1, 2026
    • Site details revised
    v6
  3. Minor Primary completion date: Jul 1, 2024 to Dec 1, 2024
    • Study completion date: Dec 1, 2024 to Aug 1, 2025
    v5
  4. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of May 30, 2023 to Aug 30, 2023
    • Study sites: 0 to 1
    v4
  5. Minor Start date: May 1, 2023 to May 30, 2023v3
  6. Minor Secondary endpoints revised (9)v2
  7. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Knee osteoarthritis is a major issue worldwide with limited treatment options. Many patients receive knee joint replacement surgery which is considered effective and safe. Nonetheless the period post-surgery is characterized by moderate to severe pain inhibiting early ambulation, motivation and range of motion, compromising rehabilitation, patient satisfaction, and overall outcomes. An optimal strategy of postoperative pain treatment after knee replacement surgery has not yet been established. Recently, our research center and others have shown that is possible to target the nerves surrounding the knee with a novel treatment called cryoneurolysis. Cryoneurolysis apply low temperatures \[-20°C ; -100°C\] to a target nerve, which disrupts nerve function and provides potential pain relief. This suggest a potential for cryoneurolysis to significantly improve rehabilitation, reduce opioid intake and overall outcomes after knee replacement surgery. The primary objective of the current project is to determine the effectiveness of cryoneurolysis in its proposed ability to reduce opioid intake and postoperative pain after knee replacement surgery. The study is a randomized controlled study with two groups. Group CRYO receives cryoneurolysis prior to knee replacement surgery and group SHAM receives a sham treatment prior to knee replacement surgery. Both groups receive surgery, analgesics and postoperative rehabilitation as per usual. Efficacy of treatment is evaluated using the change in opioid intake in the CRYO group compared to the SHAM group 14 days after knee replacement surgery. Participants will also be assessed at 90 and 180 days after knee replacement surgery and will include measures on pain, quality of life and function.
Trial Details
NCT Number NCT05840276
Lead Sponsor Esbjerg Hospital - University Hospital of Southern Denmark
Collaborators: Odense University Hospital, Boston Scientific Corporation
Conditions
(from sponsor)
Post Operative Pain, Knee Osteoarthritis, Opioid-Related Disorders
Related terms Opioid-Related Disorders, Osteoarthritis, Knee, Postoperative Pain
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov