Status:
NOT_YET_RECRUITING
Perioperative Colchicine for TKA
Lead Sponsor:
Geisinger Clinic
Collaborating Sponsors:
St. Luke's Hospital, Kansas City, Missouri
Conditions:
Osteoarthritis of Knee
Recovery Following Primary Total Knee Arthroplasty
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 (TK...
Detailed Description
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 (TK...
Eligibility Criteria
Inclusion
- Patients 18 years or older undergoing elective total knee arthroplasty for osteoarthritis.
Exclusion
- 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
Key Trial Info
Start Date :
December 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT06936709
Start Date
December 1 2025
End Date
March 1 2026
Last Update
August 17 2025
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