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

NCT02926248 | Suspended Phase 4

• 1 other identifier: 2015-707
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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.

Conditions

Manipulation Under Anesthesia

Keywords

Arthrofibrosis

Outcome Measures

Primary Outcomes (1)

• Change in Range of Motion

  Measured in Degrees by a goniometer

  Change from baseline to 3 months post-operative

Study Arms (2)

Colchicine

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Colchicine DRUG

Colchicine is an anti-fibrotic and anti-inflammatory drug

Also known as: Colcrys

Colchicine

Placebo OTHER

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead

Study Sites (1)

Hospital for Special Surgery

New York, New York, 10021, United States

Location

MeSH Terms

Interventions

Colchicine

Intervention Hierarchy (Ancestors)

Alkaloids; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2016
• First Posted: October 6, 2016
• Study Start: May 1, 2016
• Primary Completion: March 21, 2020
• Study Completion: March 1, 2021
• Last Updated: July 28, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)