Perioperative Colchicine for TKA

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorGeisinger Clinic

About this trial

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.

Eligibility criteria

Qualifiers

Patients 18 years or older undergoing elective total knee arthroplasty for osteoarthritis.

Disqualifiers

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)

Trial design

Treatments tested in this trial

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

Treatment groups

75 Participants
are divided into 3 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Geisinger Clinic

Lead sponsor

St. Luke's Hospital, Kansas City, Missouri

Collaborator