Evaluation of Post Hospital Administration of Celecoxib Following Minimally Invasive Knee Replacement Surgery
Information source: St. Louis Joint Replacement Institute
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain Management; Function; Minimally Invasive Total Knee Arthroplasty; Celecoxib
Intervention: Celecoxib (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: St. Louis Joint Replacement Institute Official(s) and/or principal investigator(s):
William C Schroer, MD, Principal Investigator, Affiliation: St. Louis Joint Replacement Institute
Overall contact:
Angie LeMarr, RN, Email: kneecenter@yahoo.com
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.
Clinical Details
Official title: Evaluation of Post Hospital Administration of Celecoxib Following Minimally Invasive Knee Replacement Surgery: A Randomized Controlled Study
Study design: Prospective
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): 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
Locations and Contacts
Angie LeMarr, RN, Email: kneecenter@yahoo.com
DePaul Health Center, St. Louis, Missouri 63044, United States; Recruiting
William C Schroer, MD, Principal Investigator
Additional Information
Starting date: June 2007
Last updated: October 22, 2007
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