Osteoarthritis of KneePhase 4NCT06936709
Perioperative Colchicine for TKA
A Phase 4 study testing Colchicine 1.8 mg + 0.6 mg in people with Osteoarthritis of Knee and Recovery Following Primary Total Knee Arthroplasty, run by Geisinger Clinic.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis of Knee, Recovery Following Primary Total Knee Arthroplasty, Perioperative Pain Control
- What is being tested?
- Colchicine 1.8 mg + 0.6 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2026to 1 Mar 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients 18 years or older undergoing elective total knee arthroplasty for osteoarthritis.
Who cannot join
- 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
Show all 20Show fewer
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Osteoarthritis of Knee, Recovery Following Primary Total Knee Arthroplasty, Perioperative Pain Control
- Being tested
- Colchicine 1.8 mg (loading dose) + Dextrose Oral Placebo, Colchicine 1.8 mg + 0.6 mg, Dextrose Oral Placebo
- Keywords
- Total Knee Arthroplasty, Colchicine, Postoperative Pain
- Medical subject headings
- Osteoarthritis, Knee, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colchicine 1.8 mg (loading dose) + Dextrose Oral PlaceboDrug
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
Colchicine 1.8 mg + 0.6 mgDrug
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.
Dextrose Oral PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Colchicine Loading Dose Only | Experimental | 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. Receives: Drug: Colchicine 1.8 mg (loading dose) + Dextrose Oral Placebo |
| Colchicine Loading Dose + Maintenance Dose | Experimental | 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. Receives: Drug: Colchicine 1.8 mg + 0.6 mg |
| Placebo Group | Placebo comparator | 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. Receives: Drug: Dextrose Oral Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative VAS pain score
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.
Measured: From postoperative day 0 through postoperative day 4.
Secondary outcomes (5)
Daily Opioid Usage
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.
Measured: From postoperative day 0 through postoperative day 3.
Postoperative KOOS-JR Score
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
Measured: From postoperative day 0 through postoperative week 12.
Postoperative Knee Flexion
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.
Measured: Postoperative day 0 through postoperative week 12.
90 day postoperative complications
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.
Measured: Postoperative day 0 to postoperative day 90
Colchicine Related Side Effects
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.
Measured: Postoperative day 0 through postoperative day 3.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2025
- Study start1 Dec 2026 (estimated)
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis of KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Geisinger Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- St. Luke's Hospital, Kansas City, Missouri
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06936709
- Sponsor's protocol ID
- 2024-0488
- Status last verified
- Sep 2026
- First submitted
- 14 Apr 2025
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Nazia, S, Robinson, K, Terrell, J. Colchicine. StatPearls Publishing. Updated January 2025. Accessed March 20, 2025., https://www.ncbi.nlm.nih.gov/books/NBK431102/
Danoff JR, Goel R, Sutton R, Maltenfort MG, Austin MS. How Much Pain Is Significant? Defining the Minimal Clinically Important Difference for the Visual Analog Scale for Pain After Total Joint Arthroplasty. J Arthroplasty. 2018 Jul;33(7S):S71-S75.e2. doi: 10.1016/j.arth.2018.02.029. Epub 2018 Feb 22.
PubMed 29567002Huang ZY, Huang Q, Wang LY, Lei YT, Xu H, Shen B, Pei FX. Normal trajectory of Interleukin-6 and C-reactive protein in the perioperative period of total knee arthroplasty under an enhanced recovery after surgery scenario. BMC Musculoskelet Disord. 2020 Apr 21;21(1):264. doi: 10.1186/s12891-020-03283-5.
PubMed 32316949Heijman MWJ, Fiolet ATL, Mosterd A, Tijssen JGP, van den Bemt BJF, Schut A, Eikelboom JW, Thompson PL, van den Ende CHM, Nidorf SM, Popa CD, Cornel JH. Association of Low-Dose Colchicine With Incidence of Knee and Hip Replacements : Exploratory Analyses From a Randomized, Controlled, Double-Blind Trial. Ann Intern Med. 2023 Jun;176(6):737-742. doi: 10.7326/M23-0289. Epub 2023 May 30.
PubMed 37247416Shvartz V, Le T, Enginoev S, Sokolskaya M, Ispiryan A, Shvartz E, Nudel D, Araslanova N, Petrosyan A, Donakanyan S, Chernov I, Bockeria L, Golukhova E. Colchicine in Cardiac Surgery: The COCS Randomized Clinical Trial. J Cardiovasc Dev Dis. 2022 Oct 20;9(10):363. doi: 10.3390/jcdd9100363.
PubMed 36286314Akl E, Sahami N, Labos C, Genest J, Zgheib A, Piazza N, Jolly S. Meta-Analysis of Randomized Trials: Efficacy and Safety of Colchicine for Secondary Prevention of Cardiovascular Disease. J Interv Cardiol. 2024 Mar 12;2024:8646351. doi: 10.1155/2024/8646351. eCollection 2024.
PubMed 38505729Nidorf SM, Fiolet ATL, Mosterd A, Eikelboom JW, Schut A, Opstal TSJ, The SHK, Xu XF, Ireland MA, Lenderink T, Latchem D, Hoogslag P, Jerzewski A, Nierop P, Whelan A, Hendriks R, Swart H, Schaap J, Kuijper AFM, van Hessen MWJ, Saklani P, Tan I, Thompson AG, Morton A, Judkins C, Bax WA, Dirksen M, Alings M, Hankey GJ, Budgeon CA, Tijssen JGP, Cornel JH, Thompson PL; LoDoCo2 Trial Investigators. Colchicine in Patients with Chronic Coronary Disease. N Engl J Med. 2020 Nov 5;383(19):1838-1847. doi: 10.1056/NEJMoa2021372. Epub 2020 Aug 31.
PubMed 32865380Si HB, Yang TM, Zeng Y, Zhou ZK, Pei FX, Lu YR, Cheng JQ, Shen B. Correlations between inflammatory cytokines, muscle damage markers and acute postoperative pain following primary total knee arthroplasty. BMC Musculoskelet Disord. 2017 Jun 17;18(1):265. doi: 10.1186/s12891-017-1597-y.
PubMed 28623906Meert L, Mertens MG, Meeus M, Vervullens S, Baert I, Beckwee D, Verdonk P, Smeets RJEM. Identification of Metabolic Factors and Inflammatory Markers Predictive of Outcome after Total Knee Arthroplasty in Patients with Knee Osteoarthritis: A Systematic Review. Int J Environ Res Public Health. 2023 May 11;20(10):5796. doi: 10.3390/ijerph20105796.
PubMed 37239524Shah K, Mohammed A, Patil S, McFadyen A, Meek RM. Circulating cytokines after hip and knee arthroplasty: a preliminary study. Clin Orthop Relat Res. 2009 Apr;467(4):946-51. doi: 10.1007/s11999-008-0562-3. Epub 2008 Oct 22.
PubMed 18941856Zhang FS, He QZ, Qin CH, Little PJ, Weng JP, Xu SW. Therapeutic potential of colchicine in cardiovascular medicine: a pharmacological review. Acta Pharmacol Sin. 2022 Sep;43(9):2173-2190. doi: 10.1038/s41401-021-00835-w. Epub 2022 Jan 19.
PubMed 35046517Inturrisi CE. Clinical pharmacology of opioids for pain. Clin J Pain. 2002 Jul-Aug;18(4 Suppl):S3-13. doi: 10.1097/00002508-200207001-00002.
PubMed 12479250Chincholkar M. Analgesic mechanisms of gabapentinoids and effects in experimental pain models: a narrative review. Br J Anaesth. 2018 Jun;120(6):1315-1334. doi: 10.1016/j.bja.2018.02.066. Epub 2018 Apr 12.
PubMed 29793598Pepper AM, Mercuri JJ, Behery OA, Vigdorchik JM. Total Hip and Knee Arthroplasty Perioperative Pain Management: What Should Be in the Cocktail. JBJS Rev. 2018 Dec;6(12):e5. doi: 10.2106/JBJS.RVW.18.00023. No abstract available.
PubMed 30562208Kirwan MJ, Diltz ZR, Dixon DT, Rivera-Peraza CA, Gammage CJ, Mihalko WM, Harkess JW, Guyton JL, Crockarell JR, Ford MC. The AAHKS Clinical Research Award: Extended Postoperative Oral Tranexamic Acid in Total Knee Arthroplasty: A Randomized Controlled Pilot Study. J Arthroplasty. 2024 Sep;39(9 Suppl 2):S13-S17. doi: 10.1016/j.arth.2024.02.073. Epub 2024 Feb 29.
PubMed 38430972
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Colchicine in the Perioperative Period on Reducing Post-Operative Pain in Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT06936709
- Acronym / sponsor ID
- 2024-0488
- Conditions
- Osteoarthritis of Knee, Recovery Following Primary Total Knee Arthroplasty, Perioperative Pain Control
- Keywords
- Total Knee Arthroplasty, Colchicine, Postoperative Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Geisinger ClinicUniversity, hospital or other
- Collaborators
- St. Luke's Hospital, Kansas City, Missouri
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 20 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Colchicine Loading Dose Only | Experimental | Drug: Colchicine 1.8 mg (loading dose) + Dextrose Oral PlaceboPatients 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. |
| Colchicine Loading Dose + Maintenance Dose | Experimental | Drug: Colchicine 1.8 mg + 0.6 mgPatients 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. |
| Placebo Group | Placebo comparator | Drug: Dextrose Oral PlaceboPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients 18 years or older undergoing elective total knee arthroplasty for osteoarthritis.
Key exclusion criteria (20 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Colchicine 1.8 mg (loading dose) + Dextrose Oral PlaceboThis 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 | Drug | Colchicine Loading Dose Only |
| Colchicine 1.8 mg + 0.6 mgThis 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. | Drug | Colchicine Loading Dose + Maintenance Dose |
| Dextrose Oral PlaceboThis 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. | Drug | Placebo Group |
Primary outcome
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.
5 secondary outcomes
Daily Opioid Usage
Time frame: From postoperative day 0 through postoperative day 3.
Postoperative KOOS-JR Score
Time frame: From postoperative day 0 through postoperative week 12.
Postoperative Knee Flexion
Time frame: Postoperative day 0 through postoperative week 12.
90 day postoperative complications
Time frame: Postoperative day 0 to postoperative day 90
Colchicine Related Side Effects
Time frame: Postoperative day 0 through postoperative day 3.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- BackgroundNazia, S, Robinson, K, Terrell, J. Colchicine. StatPearls Publishing. Updated January 2025. Accessed March 20, 2025., https://www.ncbi.nlm.nih.gov/books/NBK431102/
- Background: PubMed 29567002Danoff JR, Goel R, Sutton R, Maltenfort MG, Austin MS. How Much Pain Is Significant? Defining the Minimal Clinically Important Difference for the Visual Analog Scale for Pain After Total Joint Arthroplasty. J Arthroplasty. 2018 Jul;33(7S):S71-S75.e2. doi: 10.1016/j.arth.2018.02.029. Epub 2018 Feb 22.
- Background: PubMed 32316949Huang ZY, Huang Q, Wang LY, Lei YT, Xu H, Shen B, Pei FX. Normal trajectory of Interleukin-6 and C-reactive protein in the perioperative period of total knee arthroplasty under an enhanced recovery after surgery scenario. BMC Musculoskelet Disord. 2020 Apr 21;21(1):264. doi: 10.1186/s12891-020-03283-5.
- Background: PubMed 37247416Heijman MWJ, Fiolet ATL, Mosterd A, Tijssen JGP, van den Bemt BJF, Schut A, Eikelboom JW, Thompson PL, van den Ende CHM, Nidorf SM, Popa CD, Cornel JH. Association of Low-Dose Colchicine With Incidence of Knee and Hip Replacements : Exploratory Analyses From a Randomized, Controlled, Double-Blind Trial. Ann Intern Med. 2023 Jun;176(6):737-742. doi: 10.7326/M23-0289. Epub 2023 May 30.
- Background: PubMed 36286314Shvartz V, Le T, Enginoev S, Sokolskaya M, Ispiryan A, Shvartz E, Nudel D, Araslanova N, Petrosyan A, Donakanyan S, Chernov I, Bockeria L, Golukhova E. Colchicine in Cardiac Surgery: The COCS Randomized Clinical Trial. J Cardiovasc Dev Dis. 2022 Oct 20;9(10):363. doi: 10.3390/jcdd9100363.
- Background: PubMed 38505729Akl E, Sahami N, Labos C, Genest J, Zgheib A, Piazza N, Jolly S. Meta-Analysis of Randomized Trials: Efficacy and Safety of Colchicine for Secondary Prevention of Cardiovascular Disease. J Interv Cardiol. 2024 Mar 12;2024:8646351. doi: 10.1155/2024/8646351. eCollection 2024.
- Background: PubMed 32865380Nidorf SM, Fiolet ATL, Mosterd A, Eikelboom JW, Schut A, Opstal TSJ, The SHK, Xu XF, Ireland MA, Lenderink T, Latchem D, Hoogslag P, Jerzewski A, Nierop P, Whelan A, Hendriks R, Swart H, Schaap J, Kuijper AFM, van Hessen MWJ, Saklani P, Tan I, Thompson AG, Morton A, Judkins C, Bax WA, Dirksen M, Alings M, Hankey GJ, Budgeon CA, Tijssen JGP, Cornel JH, Thompson PL; LoDoCo2 Trial Investigators. Colchicine in Patients with Chronic Coronary Disease. N Engl J Med. 2020 Nov 5;383(19):1838-1847. doi: 10.1056/NEJMoa2021372. Epub 2020 Aug 31.
- Background: PubMed 28623906Si HB, Yang TM, Zeng Y, Zhou ZK, Pei FX, Lu YR, Cheng JQ, Shen B. Correlations between inflammatory cytokines, muscle damage markers and acute postoperative pain following primary total knee arthroplasty. BMC Musculoskelet Disord. 2017 Jun 17;18(1):265. doi: 10.1186/s12891-017-1597-y.
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- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Colchicine 1.8 mg + 0.6 mg in people with Osteoarthritis of Knee and Recovery Following Primary Total Knee Arthroplasty, run by Geisinger Clinic.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ian Barr Medical Student, MS-2, BS (814-404-6616, ibarr1@som.geisinger.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative VAS pain score (time frame: From postoperative day 0 through postoperative day 4.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06936709, which also lists 24 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.