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

Manipulation Under Anesthesia Clinical Trial

— Colchine MUA  

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT02926248
• Other study ID #: 2015-707
• Status: Suspended
• Phase: Phase 4
• Start date: May 2016
• Est. completion date: March 2021

Study information

• Verified date: July 2020
• Source: Hospital for Special Surgery, New York
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 112
• Est. completion date: March 2021
• Est. primary completion date: March 21, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Manipulation Under Anesthesia

Intervention

Drug:
• Colchicine
Colchicine is an anti-fibrotic and anti-inflammatory drug

Other:
• Placebo

Locations

Country	Name	City	State
United States	Hospital for Special Surgery	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Hospital for Special Surgery, New York

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Range of Motion	Measured in Degrees by a goniometer	Change from baseline to 3 months post-operative