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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Colchicine on Range of Motion After Manipulation Under Anesthesia for the Stiff Total Knee Replacement: A Prospective Randomized Controlled Trial

Conditions
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Manipulation Under Anesthesia

Intervention / Treatment
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* Drug: Colchicine
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Colchicine<br>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. | Drug: Colchicine<br>* Colchicine is an anti-fibrotic and anti-inflammatory drug<br>* Other names: Colcrys;|
| Placebo Comparator: Placebo<br>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. | Other: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Range of Motion | Measured in Degrees by a goniometer | Change from baseline to 3 months post-operative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Arthrofibrosis