Perioperative Colchicine for TKA (NCT06936709) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Perioperative Colchicine for TKA
75 participantsStarted 2025-12-01
Plain-language summary
This study is a prospective, randomized, double-blinded, placebo-controlled study of the drug colchicine in the acute postoperative period for patients who are undergoing a total knee arthroplasty (TKA). Patients aged 18 years or older who are undergoing TKA will be invited to participate in the study. The primary endpoint of this study is to determine if colchicine, an anti-inflammatory medication commonly used for gout attacks, will decrease the postoperative pain of patients undergoing elective 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 18 years or older undergoing elective total knee arthroplasty for osteoarthritis.
Exclusion Criteria:
* Subject has impaired hepatic function (Child-Pugh Class \>B)
* Subject has impaired renal function (GFR \< 60 ml/min/1.73 m2)
* Subject has known adverse reaction to colchicine
* Subject has chronic opioid use (Filled opioid medication twice within 6 months of surgical date)
* Subject is pregnant or expecting to become pregnant during the time of the study associated with colchicine exposure (postoperative days 0-3)
* Subject is unable to provide informed consent
* Subject is actively prescribed medication that interact with colchicine in a manner that would increase the risk of colchicine toxicity, i.e.:
* Antifungals: Ketoconazole, itraconazole, fluconazole, etc…
* Macrolides : Clarithromycin, erythromycin
* HIV protease : Ritonavir, Atazanavir, saquinavir, etc...
* Ca2+: Verapamil and Diltiazem
* Cyclosporine
* Danazol
* Amiodorone
* Quinidine
* Anti-hepaciviral combinations
* Grapefruit juice
* Statins: atorvastatin, lovastatin, simvastatin, etc…
* Gemfibrozil and other fibrates
* Digoxin
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
Postoperative VAS pain score
Timeframe: From postoperative day 0 through postoperative day 4.