Perioperative Colchicine for TKA

August 15, 2025 updated by: John Mercuri, MD, Geisinger Clinic

Effect of Colchicine in the Perioperative Period on Reducing Post-Operative Pain in Total Knee Arthroplasty

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 (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.

Study Type

Interventional

Enrollment (Estimated)

75

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Colchicine Loading Dose Only
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.
Drug: Colchicine 1.8 mg (loading dose) + Dextrose Oral Placebo
This intervention will be used for individuals in arm A of the study who will receive a loading dose of colchicine (1.8 mg) on postoperative day 0, and will then be given placebo oral dextrose pills to take twice daily on postoperative days 1-3
Experimental: Colchicine Loading Dose + Maintenance Dose
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.
Drug: Colchicine 1.8 mg + 0.6 mg
This intervention is will be given to patients in arm B of the study who will receive a loading dose of colchicine (1.8 mg) on postoperative day 0, followed by a maintenance does of colchicine (0.6 mg) to be taken twice daily on postoperative days 1-3.
Placebo Comparator: Placebo Group
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.
Drug: Dextrose Oral Placebo
This intervention will be for patients in arm C, the placebo arm. These patients will receive oral dextrose pills to be taken once on postoperative day 0, and twice daily on postoperative days 1-3.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative VAS pain score
Time Frame: From postoperative day 0 through postoperative day 4.
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. 0 being no pain, 10 being the worst pain they have ever experienced.
From postoperative day 0 through postoperative day 4.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Daily Opioid Usage
Time Frame: From postoperative day 0 through postoperative day 3.
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 the total pills of the prescribed postoperative opioid they have taken each day on postoperative days 1-3.
From postoperative day 0 through postoperative day 3.
Postoperative KOOS-JR Score
Time Frame: From postoperative day 0 through postoperative week 12.

Subjects will complete the 7-question KOOS-JR questionnaire at their 2-, 6-, and 12-week post-operative visits. Scoring ranges from 0-28, measuring variables from 0 (none) to 4 (extreme). Questions asked are: How severe is your knee stiffness after first wakening in the morning? What amount of knee pain have you experienced the last week during the following activities?

  • Twisting/pivoting on your knee
  • Straightening knee fully
  • Going up or down stairs
  • Standing upright And the what degree of difficulty have you had with the following activities?
  • Rising from sitting
  • Bending to floor/pick up an object
From postoperative day 0 through postoperative week 12.
Postoperative Knee Flexion
Time Frame: Postoperative day 0 through postoperative week 12.
Subject's knee flexion will be assessed at their 2-, 6-, and 12- week postoperative visits to assess recovery from their TKA. Values will be recording in degree of flexion, representing their range of motion.
Postoperative day 0 through postoperative week 12.
90 day postoperative complications
Time Frame: Postoperative day 0 to postoperative day 90
Subject's 90-day postoperative complications such as ED visits, unplanned readmission, joint infection, wound dehiscence, deep vein thrombosis, pulmonary embolism, or return to OR, etc. Assessment of these complications will be done through a chart review of the subject's electronic health records.
Postoperative day 0 to postoperative day 90
Colchicine Related Side Effects
Time Frame: Postoperative day 0 through postoperative day 3.
The assessment of colchicine related side effects such as diarrhea, vomiting, abdominal pain, nausea, fatigue, headache, and pharyngolaryngeal pain will be recorded by subjects in the postoperative journal that they will receive on postoperative day 0. A checkbox will be present for each known side-effect for patients to self-report if they have had any of the aforementioned symptoms.
Postoperative day 0 through postoperative day 3.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Geisinger Clinic

Collaborators

St. Luke's Hospital, Kansas City, Missouri

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2025

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

March 1, 2026

Study Registration Dates

First Submitted

April 14, 2025

First Submitted That Met QC Criteria

April 14, 2025

First Posted (Actual)

April 20, 2025

Study Record Updates

Last Update Posted (Actual)

August 17, 2025

Last Update Submitted That Met QC Criteria

August 15, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-0488

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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