Cryo and Compression Therapy After TKA and UKA (NCT05572359) | Clinical Trial Compass
CompletedNot Applicable
Cryo and Compression Therapy After TKA and UKA
Netherlands208 participantsStarted 2023-05-25
Plain-language summary
The goal of this clinical trial is to test the use of a cold and compression brace during the first 6 weeks after surgery in patients who had a total or partial knee replacement.
The main question\[s\] it aims to answer are:
* What is the effect of the use of cryo- and compression therapy during the first 6 postoperative weeks after knee replacement surgery on pain in rest?
* What is the effect of the use of cryo- and compression therapy during the first 6 postoperative weeks after knee replacement surgery on pain while loading, opioid use, functioning, patient satisfaction and general health, and do participants comply with the therapy?
Participants will be asked to use the cold and compression brace during the six weeks after surgery five times a day, for a maximum of 20 minutes. Researchers will compare with usual care to see the effect on pain, opioid use, functioning, satisfaction and general health.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients scheduled for a primary TKA or UKA in the Martini Hospital.
* Age ≥ 18 years
Exclusion Criteria:
* per-operative switch from UKA to TKA (only applicable for the UKA patients),
* revision TKA implant (only applicable for the TKA patients),
* rheumatoid arthritis,
* other co-morbidities on which cooling may have a negative effect on (based on judgement of the orthopaedic surgeon),
* inability to read and understand the Dutch language.
Because the cool pack needs to be cooled in a freezer, it is required that a patient or the nursing home has a freezer that can be used.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.