Perioperative Colchicine for TKA
Launched by GEISINGER CLINIC · Apr 14, 2025
Trial Information
Current as of June 26, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is studying the use of a medication called colchicine to see if it can help reduce pain after surgery for knee replacement, known as total knee arthroplasty (TKA). Colchicine is an anti-inflammatory drug that is typically used to treat gout, a type of arthritis. The trial will involve adults aged 18 and older who are scheduled for this surgery due to osteoarthritis. The main goal is to find out if taking colchicine after the surgery can lead to less pain during recovery.
To be eligible for this study, participants must be undergoing elective knee replacement surgery and must not have certain health conditions, such as severe liver or kidney problems, or a history of allergic reactions to colchicine. Additionally, individuals who use strong pain medications regularly or who are pregnant cannot participate. Those who join the study will receive either colchicine or a placebo (a harmless sugar pill) without knowing which one they have, to ensure that the results are fair and unbiased. This trial is an important step in finding better ways to manage pain after knee surgery, helping patients recover more comfortably.
Gender
ALL
Eligibility criteria
- 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
About Geisinger Clinic
Geisinger Clinic is a leading healthcare organization based in Pennsylvania, recognized for its commitment to innovative patient care and research. As a clinical trial sponsor, Geisinger Clinic integrates cutting-edge medical research with a focus on improving health outcomes through evidence-based practices. The organization leverages its extensive electronic health record system and diverse patient population to facilitate comprehensive clinical studies that advance medical knowledge and enhance therapeutic options. With a strong emphasis on collaboration and community engagement, Geisinger Clinic aims to translate research findings into practical solutions that benefit patients and the healthcare system as a whole.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported