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

Evaluation of Post Hospital Administration of Celecoxib Following Minimally Invasive Knee Replacement Surgery: A Randomized Controlled Study

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.

Study Overview

• Status: Completed
• Conditions: Pain Management; Function; Celecoxib; Minimally Invasive Total Knee Arthroplasty
• Intervention / Treatment: Drug: Celecoxib

• Study Type: Observational
• Enrollment (Actual): 107

Contacts and Locations

Study Locations

• United States
  • Missouri
    • St. Louis, Missouri, United States, 63044
      • DePaul Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

total knee canidates

Description

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 Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: St. Louis Joint Replacement Institute
• Collaborators: Pfizer; Zimmer Biomet
• Investigators: Principal Investigator: William C Schroer, MD, St. Louis Joint Replacement Institute

Study record dates

Study Major Dates

• Study Start: June 1, 2007
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: May 15, 2007
• First Submitted That Met QC Criteria: May 15, 2007
• First Posted (Estimate): May 17, 2007

Study Record Updates

• Last Update Posted (Estimate): April 28, 2016
• Last Update Submitted That Met QC Criteria: April 26, 2016
• Last Verified: January 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Cyclooxygenase 2 Inhibitors; Celecoxib
• Other Study ID Numbers: GA3190YM