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.
Patients 18 years or older undergoing elective total knee arthroplasty for osteoarthritis.
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)
Factorial
Colchicine 1.8 mg (loading dose) + Dextrose Oral Placebo
DrugThis 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 mg
DrugThis 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 Placebo
DrugThis 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.
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.
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.
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
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.
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.
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Geisinger Clinic
Lead sponsor
St. Luke's Hospital, Kansas City, Missouri
Collaborator
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