Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2025-12-25 @ 4:05 AM
NCT ID:
NCT06088602
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06088602
Study Brief:
Protocol Section:
NCT06088602