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

NCT00474773 | Completed

• 1 other identifier: GA3190YM
• Study Type: observational
• Target: 107
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain Management; Function; Minimally Invasive Total Knee Arthroplasty; Celecoxib

Interventions

Celecoxib DRUG

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

total knee canidates

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Louis Joint Replacement Institute: lead
• Pfizer: collaborator
• Zimmer Biomet: collaborator

Study Sites (1)

DePaul Health Center

St Louis, Missouri, 63044, United States

Location

MeSH Terms

Conditions

Agnosia

Interventions

Celecoxib

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• William C Schroer, MD

  St. Louis Joint Replacement Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2007
• First Posted: May 17, 2007
• Study Start: June 1, 2007
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: April 28, 2016

Record last verified: 2010-01

Locations

US (1)