Manipulation Under Anesthesia
Conditions
Keywords
Arthrofibrosis
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.
Interventions
DRUGColchicine
Colchicine is an anti-fibrotic and anti-inflammatory drug
OTHERPlacebo
Sponsors
Hospital for Special Surgery, New York
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Range of Motion | Change from baseline to 3 months post-operative | Measured in Degrees by a goniometer |
Countries
United States
Outcome results
None listed