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

Paused · Phase 4 · Has a placebo group

Conditions studied: Manipulation Under Anesthesia

In brief

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.

Key facts

Study ID

NCT02926248

Run by

Hospital for Special Surgery, New York

People needed

112

Starts

2016-05-01

Expected to finish

2021-03-01

Last updated by the study team

2020-07-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Hospital for Special Surgery — New York, New York, United States

Full record on ClinicalTrials.gov

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