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

Hospital for Special Surgery (HSS)

Status and phase: Suspended; Phase 4

Conditions: Manipulation Under Anesthesia

Treatments: Drug: Colchicine; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02926248

2015-707

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 112 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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112 participants in 2 patient groups, including a placebo group

Colchicine

Experimental group

Description:

Manipulation under Anesthesia (MUA) will be performed prior to 12 weeks after the index TKA. Patients will be randomized to oral colchicine 0.6 mg twice daily for 6 weeks. All patients will follow a standardized post-MUA physical therapy protocol.

Treatment:

Drug: Colchicine

Placebo

Placebo Comparator group

Description:

Manipulation under Anesthesia (MUA) will be performed prior to 12 weeks after the index TKA. Patients will be randomized to oral placebo twice daily for 6 weeks. All patients will follow a standardized post-MUA physical therapy protocol.

Treatment:

Other: Placebo