Effect of Colchicine on Range of Motion After Manipulation Under Anesthesia for the Stiff Total Knee Replacement

Adult primary unilateral TKA patients with less than 90° of knee flexion between 5 and 12
weeks after their index surgery will be screened for trial eligibility based on the inclusion
and exclusion criteria above. Only patients from the protocol surgeons will be eligible to
participate in this trial. MUA will be performed prior to 12 weeks after the index TKA.
Patients will be randomized to either oral colchicine 0.6 mg twice daily for 6 weeks
(treatment arm) or to oral placebo twice daily for 6 weeks in the placebo arm. All patients
will follow a standardized post-MUA physical therapy protocol. Data will be collected
prospectively, including study data collection sheets and medication diary. Other data
sources will include office and inpatient medical records, operative reports, physical
therapy records, hospital picture archiving and communication system (PACS) and radiology
records. Outcomes will be collected at MUA, 6 weeks, 3 months, and 1 year.

Inclusion Criteria:

- Primary unilateral TKA indicated for MUA (knee flexion angle less than 90°)

- Primary Diagnosis of OA for TKA

- MUA indicated within 5 to 12 weeks of primary surgery

- Age greater than or equal to 18 years

- Patients with less than 10 degrees of a flexion contracture

Exclusion Criteria:

- Patients who are wheelchair bound

- Patients requiring concomitant arthroscopic or open procedures

- Revision TKA

- Patients requiring bilateral MUA

- Patients with renal disease (Creatinine > 1.5, and/or estimated creatinine clearance
less than 30 mL/min)

- Patients with hepatic disease (known liver disease, cirrhosis, and/or AST/ALT>60)

- Patients concurrently taking strong CYP3A4 inhibitors:

- Atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone,
nelfinavir, ritonavir, saquinavir, telithromycin, amprenavir, aprepitant,
diltiazem, erythromycin, fluconazole, fosamprenavir, grapefruit juice, verapamil

- Patients concurrently taking strong P-glycoprotein inhibitors:

- Cyclosporine, ranolazine

- Patients concurrently taking medications that increase the risk for myopathy and
rhabdomyolysis:

- atorvastatin, fluvastatin, pravastatin, simvastatin, fibrates, gemfibrozil,
digoxin

- Patients with a history of blood dyscrasias

- Pregnant patients

- Patients who are nursing mothers

- Patients with reported allergy to colchicine

- Non-English speaking patients