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

• Status: Suspended
• Trial end date: 2021-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The specific aim of this study is to evaluate the effect of oral colchicine in primary TKA patients at 3 months following a manipulation under anesthesia.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: David J. Mayman; Hospital for Special Surgery, New York
• Treatments: Anesthetics; Colchicine

Criteria

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