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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00474773
First Posted: May 17, 2007
Last Update Posted: April 28, 2016
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.
Collaborators:
Pfizer
Zimmer Biomet
Information provided by (Responsible Party):
St. Louis Joint Replacement Institute
  Purpose

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 Intervention Phase
Pain Management Function Minimally Invasive Total Knee Arthroplasty Celecoxib Drug: Celecoxib Phase 4

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by St. Louis Joint Replacement Institute:

Enrollment: 107
Study Start Date: June 2007
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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

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
  Contacts and Locations
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


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

Responsible Party: St. Louis Joint Replacement Institute
ClinicalTrials.gov Identifier: NCT00474773     History of Changes
Other Study ID Numbers: GA3190YM
First Submitted: May 15, 2007
First Posted: May 17, 2007
Last Update Posted: April 28, 2016
Last Verified: January 2010

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