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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 : Recruiting
First Posted : October 6, 2016
Last Update Posted : August 3, 2018
Sponsor:
Information provided by (Responsible Party):
Hospital for Special Surgery, New York

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 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
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Colchicine

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



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



Information from the National Library of Medicine

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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

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


Contacts
Contact: David J Mayman, MD maymand@hss.edu

Locations
United States, New York
Hospital for Special Surgery Recruiting
New York, New York, United States, 10021
Contact: David J Mayman, MD       maymand@hss.edu   
Sponsors and Collaborators
Hospital for Special Surgery, New York

Responsible Party: Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT02926248     History of Changes
Other Study ID Numbers: 2015-707
First Posted: October 6, 2016    Key Record Dates
Last Update Posted: August 3, 2018
Last Verified: August 2018
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:
Anesthetics
Colchicine
Central Nervous System Depressants
Physiological Effects of Drugs
Gout Suppressants
Antirheumatic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents