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

NCT ID: NCT02926248

Last Updated: 2020-07-28

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: PHASE4
• Total Enrollment: 112 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2021-03-31

Brief 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.

Detailed 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.

Conditions

Manipulation Under Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Colchicine

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.

Group Type: EXPERIMENTAL

Colchicine

Intervention Type: DRUG

Colchicine is an anti-fibrotic and anti-inflammatory drug

Placebo

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Interventions

Colchicine

Colchicine is an anti-fibrotic and anti-inflammatory drug

Intervention Type: DRUG

Placebo

Intervention Type: OTHER

Other Intervention Names

Colcrys

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hospital for Special Surgery, New York

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hospital for Special Surgery

New York, New York, United States

Countries

United States

Other Identifiers

2015-707

Identifier Type: -

Identifier Source: org_study_id