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

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ClinicalTrials.gov Identifier: NCT02926248
Recruitment Status : Suspended (Continuing IRB review was not submitted. Study was inactivated with the institutional IRB.)
First Posted : October 6, 2016
Last Update Posted : July 28, 2020
Sponsor:
Information provided by (Responsible Party):
Hospital for Special Surgery, New York

Study Description
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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.

Condition or disease Intervention/treatment Phase
Manipulation Under Anesthesia Drug: Colchicine Other: Placebo Phase 4

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effect of Colchicine on Range of Motion After Manipulation Under Anesthesia for the Stiff Total Knee Replacement: A Prospective Randomized Controlled Trial
Study Start Date : May 2016
Actual Primary Completion Date : March 21, 2020
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Colchicine

Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Drug: Colchicine
Colchicine is an anti-fibrotic and anti-inflammatory drug
Other Name: Colcrys
Placebo Comparator: 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.
 Other: Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Change in Range of Motion [ Time Frame: Change from baseline to 3 months post-operative ]
    Measured in Degrees by a goniometer


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02926248


Locations
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United States, New York
Hospital for Special Surgery
New York, New York, United States, 10021
Sponsors and Collaborators
Hospital for Special Surgery, New York
More Information
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Responsible Party: Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT02926248    
Other Study ID Numbers: 2015-707
First Posted: October 6, 2016    Key Record Dates
Last Update Posted: July 28, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Hospital for Special Surgery, New York:
Arthrofibrosis
Additional relevant MeSH terms:
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Colchicine
Gout Suppressants
Antirheumatic Agents
Tubulin Modulators
 Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents