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

This study is ongoing, but not recruiting participants.

First Received: May 15, 2007 Last Updated: April 9, 2009 History of Changes

Sponsor:	St. Louis Joint Replacement Institute
Collaborators:	Pfizer Biomet, Inc.
Information provided by:	St. Louis Joint Replacement Institute
ClinicalTrials.gov Identifier:	NCT00474773

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 IV

Study Type:	Observational
Study Design:	Cohort, 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:

MedlinePlus related topics: Knee Replacement Surgery

Drug Information available for: Celecoxib

U.S. FDA Resources

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

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

Eligibility

Genders Eligible for Study:

Both

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00474773

Locations

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

Sponsors and Collaborators

St. Louis Joint Replacement Institute

Pfizer

Biomet, Inc.

Investigators

Principal Investigator:

William C Schroer, MD

St. Louis Joint Replacement Institute

More Information

No publications provided

Study ID Numbers:	GA3190YM
Study First Received:	May 15, 2007
Last Updated:	April 9, 2009
ClinicalTrials.gov Identifier:	NCT00474773 History of Changes
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Celecoxib
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase Inhibitors
Physiological Effects of Drugs
Enzyme Inhibitors
Pharmacologic Actions
Analgesics, Non-Narcotic

Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010