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

Sponsor

Hospital for Special Surgery, New York (Other)

Overall Status

Suspended

CT.gov ID

NCT02926248

Collaborator

(none)

112

Enrollment

Location

Arms

Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

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

Study Type:

Interventional

Anticipated 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 1, 2016

Actual Primary Completion Date :

Mar 21, 2020

Anticipated Study Completion Date :

Mar 1, 2021

Arms and Interventions

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 Names: 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

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 Names:

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

Primary Outcome Measures

Change in Range of Motion [Change from baseline to 3 months post-operative]
Measured in Degrees by a goniometer

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Hospital for Special Surgery	New York	New York	United States	10021

Sponsors and Collaborators

Hospital for Special Surgery, New York

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hospital for Special Surgery, New York

ClinicalTrials.gov Identifier:

NCT02926248

Other Study ID Numbers:

2015-707

First Posted:

Oct 6, 2016

Last Update Posted:

Jul 28, 2020

Last Verified:

Jul 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Keywords provided by Hospital for Special Surgery, New York

Arthrofibrosis

Additional relevant MeSH terms:

Colchicine

Study Results

No Results Posted as of Jul 28, 2020