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

Pain Management Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00474773
• Other study ID #: GA3190YM
• Status: Completed
• Phase: Phase 4
• First received: May 15, 2007
• Last updated: April 26, 2016
• Start date: June 2007
• Est. completion date: December 2009

Study information

• Verified date: January 2010
• Source: St. Louis Joint Replacement Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Intervention

Drug:
• Celecoxib

Locations

Country	Name	City	State
United States	DePaul Health Center	St. Louis	Missouri

Sponsors (3)

Lead Sponsor	Collaborator
St. Louis Joint Replacement Institute	Biomet, Inc., Pfizer

Country where clinical trial is conducted

United States,