Evaluation of Post Hospital Administration of Celecoxib Following Minimally Invasive Knee Replacement Surgery

Completed

• Conditions: Pain Management; Function; Minimally Invasive Total Knee Arthroplasty; Celecoxib

• Registration Number: NCT00474773
• Lead Sponsor: St. Louis Joint Replacement Institute

Brief Summary

This study will evaluate the benefits of continuing celecoxib through six weeks of total knee arthroplasty recovery. This is a randomized, double blind study with a group of approximately 130 primary total knee patients. All patients will receive celecoxib throughout their hospitalization as per current minimally invasive total knee arthroplasty protocol. At the time of hospital discharge, participating patients will be randomly placed on either celecoxib 200mg twice a day or a placebo twice a day.

This study will determine if the continued use of celecoxib for six weeks after total knee arthroplasty hospitalization will further decrease narcotic consumption, improve knee range of motion, improve ambulatory ability, and improve patient satisfaction over patients receiving celecoxib only during the acute hospitalization.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-05-15
• Study First Submitted QC: 2007-05-15
• Study First Posted: 2007-05-17
• Study Start: 2007-06
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Status Verified: 2010-01
• Last Update Submitted: 2016-04-26
• Last Update Posted: 2016-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 107

Inclusion Criteria

• having undergone a minimally invasive total knee by select surgeon
• voluntarily enrolled
• independent community ambulators
• only patients being discharged directly home

Exclusion Criteria

• celecoxib allergy or intolerence
• Renal insufficiency (defined as serum creatine level >1.5 mg/dL or BUN level >22mg/dL
• History of bleeding gastic or duodenal ulceration
• New York Heart Association Class III or IV Congestive Heart Failure
• Previous myocardial infarction or cerebralvascular event
• Severe inflammatory bowel disease
• Known coagulation abnormality or hepatic disease
• Chronic coumadin administration
• Refusal by primary or cardiac physician

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

DePaul Health Center; 🇺🇸 St. Louis, Missouri, United States