Cryoneurolysis treatment before knee replacement surgery
Cryoneurolysis Prior to Total Knee Arthroplasty for the Management of Postoperative Pain; A Randomized, Sham-controlled, Trial
This study is testing if a new cold therapy for knee nerves can help people feel less pain and recover better after knee replacement surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Esbjerg Hospital - University Hospital of Southern Denmark Academic / other |
| Locations | 1 site (Esbjerg, Region Of Southern Denmark) |
| Trial ID | NCT05840276 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of cryoneurolysis, a novel technique that applies low temperatures to target nerves around the knee, to alleviate postoperative pain following total knee arthroplasty. The study aims to determine if this approach can improve rehabilitation outcomes, reduce opioid consumption, and enhance overall patient satisfaction after surgery. Participants will be randomly assigned to receive either cryoneurolysis or a sham treatment, allowing for a comparison of pain relief and recovery metrics. The trial is particularly relevant given the increasing number of knee replacement surgeries and the challenges associated with postoperative pain management.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older scheduled for unilateral primary total knee arthroplasty.
Not a fit: Patients with a history of neuropathic pain or those on high doses of opioids may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce postoperative pain and improve recovery for patients undergoing knee replacement surgery.
How similar studies have performed: Other studies have shown promise with nerve-targeting techniques for pain management, suggesting potential for success with cryoneurolysis.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Scheduled for unilateral, primary total knee arthroplasty * Age ≥ 18y * Written and oral understanding of Danish. Exclusion Criteria: * Contraindications against ibuprofen or paracetamol, for example previous gastric ulcer, or known renal failure (eGRF \< 60 ml/kg/1,73m2), known thrombocytopenia (\< 100 bil/l); or against treatment with morphine * History of neuropathic pain * Previous recipient of cryoneurolysis for the knee * Patients with daily use of high dose opioid (\> oral morphine 30 mg/day or oxycodone 30 mg/day or tramadol 150 mg/day) or any use of other opioids including methadone and transdermal opioids * Uncontrolled serious disease (cancer, diabetes, etc.) * Disease associated with reactions to cold, such as cryoglobulinemia, cold urticarial and Reynaud's syndrome.
Where this trial is running
Esbjerg, Region Of Southern Denmark
- Hospital of Southwest Jutland — Esbjerg, Region Of Southern Denmark, Denmark (Recruiting)
Study contacts
- Principal investigator: Niels-Peter B Nygaard, PhD — Esbjerg Hospital - University Hospital of Southern Denmark
- Study coordinator: Niels-Peter B Nygaard, PhD
- Email: niels-peter.brochner.nygaard@rsyd.dk
- Phone: DK+20612033
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.