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Perioperative Colchicine for TKA

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Geisinger Health

Status and phase

Begins enrollment this month
Phase 4

Conditions

Recovery Following Primary Total Knee Arthroplasty
Osteoarthritis of Knee
Perioperative Pain Control

Treatments

Drug: Colchicine 1.8 mg + 0.6 mg
Drug: Colchicine 1.8 mg (loading dose) + Dextrose Oral Placebo
Drug: Dextrose Oral Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT06936709
2024-0488

Details and patient eligibility

About

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.

Full 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 (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 TKA.

In doing so, we will utilize a 3-arm approach with two experimental groups and one placebo group. Qualifying subjects will be randomized 1:1:1 to Group A receiving a 1.8 mg loading dose of colchicine, Group B receiving the same loading dose + 0.6 mg maintenance dose of colchicine to be taken twice daily, and Group C receiving a placebo.

Regarding study procedures, standard preoperative and intraoperative procedures will be employed to ensure experimental and control groups have a nearly equivalent experience before the intervention. Subjects will be discharged with the same ambulation instructions and physical therapy regimens. Aside from the experimental drug, patients will receive the same postoperative pain medications upon discharge.

Research staff in the Geisinger pharmacy will receive and prepare the oral medication for dispensing, which will include randomizing identification numbers to colchicine or placebo, labeling packages with study identification numbers and subject information, and ensuring there is no visible method to discern colchicine from placebo. Colchicine is to be stored at room temperature.

Providers and subjects will be blinded regarding whether the subject will receive a colchicine loading dose + the placebo pills for maintenance doses, a colchicine loading dose + colchicine for maintenance doses, or the placebo pills for both. Group A will receive a 1.8 mg loading dose of colchicine by mouth on postoperative day 0 and will be instructed to take a placebo by mouth twice daily on postoperative days 1-3. Group B will receive a 1.8 mg loading dose of colchicine by mouth on postoperative 0 and will be instructed to take a 0.6 mg maintenance dose of colchicine by mouth twice daily on postoperative days 1-3. Group C will receive placebo dextrose pills by mouth on postoperative day 0 and will be instructed to take the placebo by mouth twice daily on postoperative days 1-3. Subjects will be sent home with an adequate supply of pills for postoperative days 1-3 and instructions on use.

The procedure for measuring the study variables is as follows:

Subjects will receive a post-operative pain journal upon hospital discharge on postoperative day 0. The journal will include three time points (morning, midday, and bedtime) in which they will record a VAS pain score ranging from 0-10 for post-operative days 1-3. The journal will also include a box for subjects to record the total pills of the prescribed postoperative opioid they have taken each day on postoperative days 1-3. Lastly, the journal will include a checkbox at the end for subjects to record whether they have experienced known colchicine-related side effects on postoperative days 1-3 such as nausea, vomiting, diarrhea, and abdominal pain. For evaluation of KOOS-JR scores and knee flexion, subjects will complete the 7-question KOOS-JR questionnaire at their 2-, 6-, and 12-week post-operative visits, and at these visits, a member of the research staff will determine the subject's knee flexion. Lastly, regarding the assessment of 90-day postoperative complications, the researchers will conduct a review of the subject's EHR.

Enrollment

75 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Triple Blind

75 participants in 3 patient groups, including a placebo group

Colchicine Loading Dose Only
Experimental group
Description:
Patients in this arm will receive 1.8 mg of colchicine on postoperative day 0. This dosage aligns with standard of care loading dose for acute gout attacks. This will be a one time dosage of colchicine. On postoperative days 1-3, patients will take placebo dextrose pills twice daily.
Treatment:
Drug: Colchicine 1.8 mg (loading dose) + Dextrose Oral Placebo
Colchicine Loading Dose + Maintenance Dose
Experimental group
Description:
Patients in this arm will receive a 1.8 mg loading dose of colchicine on postoperative day 0. They will then take a 0.6 mg maintenance dose twice daily on postoperative days 1-3. This dosage of colchicine in this arm models standard of care dosing for acute gout attacks.
Treatment:
Drug: Colchicine 1.8 mg + 0.6 mg
Placebo Group
Placebo Comparator group
Description:
Patients in this arm will receive a placebo dextrose pill on postoperative day 0. They will then take a placebo dextrose pill twice daily on postoperative days 1-3.
Treatment:
Drug: Dextrose Oral Placebo

Trial contacts and locations

0

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Central trial contact

John Mercuri Principal Investigator, MD; Ian Barr Medical Student, MS-2, BS

Data sourced from clinicaltrials.gov

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