Safety Study of High-dose Methylprednisolone in Fast-track Total Knee Arthroplasty (NCT02019511) | Clinical Trial Compass
WithdrawnNot Applicable
Safety Study of High-dose Methylprednisolone in Fast-track Total Knee Arthroplasty
Stopped: The study design was too complex regarding aquisition of registry data.
Denmark0Started 2013-10
Plain-language summary
It has been shown that a single high dose of steroid before surgery may reduce pain the first 48 hours after insertion of a new joint in the knee, a so called "total knee arthroplasty" (TKA). Consequently, this has been introduced as standard treatment of most patients at several Danish orthopedic departments. Although there are some concerns about the possibility of increased risk of prosthesis infections, this has not been proved in previous studies. However the studies are few, have limited number of patients and are not done using a standardized perioperative set-up.
This study is made to monitor the safety of a single high dose steroid injection before TKA, with regards to prosthesis infection within one year of surgery.
We hypothesize that there will be no increase in infections in patients receiving steroid injection before TKA compared to a historical cohort of patents who did not receive a steroid injection before their TKA.
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 primary unilateral elective TKA and no contraindications for high-dose Methylprednisolone preoperatively
* Danish Social security number
Exclusion Criteria:
One of the following contraindications for Methylprednisolone:
* Allergy against Methylprednisolone.
* Currently in systemic treatment with glucocorticoid
* Current gastric ulcer
* Insulin dependent diabetes mellitus
Further contraindications are at the discretion of the individual department/surgeon. The cohort without preoperative Methylprednisolone treatment will be followed as a separate cohort to identify potential selection bias.
\- Citizens without Danish social security number are not eligible for this study as follow-up is not possible.
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.
What they're measuring
1
prosthesis related infections within 1 year after TKA