We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00474773
Recruitment Status : Completed
First Posted : May 17, 2007
Last Update Posted : April 28, 2016
Zimmer Biomet
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Pain Management Function Minimally Invasive Total Knee Arthroplasty Celecoxib Drug: Celecoxib Phase 4

Study Type : Observational
Actual Enrollment : 107 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Post Hospital Administration of Celecoxib Following Minimally Invasive Knee Replacement Surgery: A Randomized Controlled Study
Study Start Date : June 2007
Primary Completion Date : December 2009
Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Celecoxib
U.S. FDA Resources

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
total knee canidates

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00474773

United States, Missouri
DePaul Health Center
St. Louis, Missouri, United States, 63044
Sponsors and Collaborators
St. Louis Joint Replacement Institute
Zimmer Biomet
Principal Investigator: William C Schroer, MD St. Louis Joint Replacement Institute

Responsible Party: St. Louis Joint Replacement Institute
ClinicalTrials.gov Identifier: NCT00474773     History of Changes
Other Study ID Numbers: GA3190YM
First Posted: May 17, 2007    Key Record Dates
Last Update Posted: April 28, 2016
Last Verified: January 2010

Additional relevant MeSH terms:
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents