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

• ClinicalTrials.gov Identifier: NCT02926248
• Recruitment Status: Suspended
• First Posted: October 6, 2016
• Last Update Posted: July 28, 2020
• Sponsor: Hospital for Special Surgery, New York
• Information provided by (Responsible Party): Hospital for Special Surgery, New York

Tracking Information

• First Submitted Date: June 24, 2016
• First Posted Date: October 6, 2016
• Last Update Posted Date: July 28, 2020
• Study Start Date: May 2016
• Actual Primary Completion Date: March 21, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 5, 2016)

Change in Range of Motion [ Time Frame: Change from baseline to 3 months post-operative ]

Measured in Degrees by a goniometer

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Effect of Colchicine on Range of Motion After Manipulation Under Anesthesia for the Stiff Total Knee Replacement
• Official Title: Effect of Colchicine on Range of Motion After Manipulation Under Anesthesia for the Stiff Total Knee Replacement: A Prospective Randomized Controlled Trial
• 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.
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Treatment
• Condition: Manipulation Under Anesthesia

Intervention

• Drug: Colchicine
  Colchicine is an anti-fibrotic and anti-inflammatory drug
  Other Name: Colcrys
• Other: Placebo

Study Arms

• 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.
  Intervention: Drug: Colchicine
• 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.
  Intervention: Other: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Suspended
• Estimated Enrollment (submitted: October 5, 2016): 112
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: March 2021
• Actual Primary Completion Date: March 21, 2020 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02926248
• Other Study ID Numbers: 2015-707
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Hospital for Special Surgery, New York
• Original Responsible Party: David J. Mayman, Hospital for Special Surgery, New York, Associate Professor in Orthopaedic Surgery
• Current Study Sponsor: Hospital for Special Surgery, New York
• Original Study Sponsor: David J. Mayman
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Hospital for Special Surgery, New York
• Verification Date: July 2020