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

NCT ID: NCT00474773

Last Updated: 2016-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

107 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-06-30

Study Completion Date

2009-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pain Management Function Minimally Invasive Total Knee Arthroplasty Celecoxib

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Celecoxib

Intervention Type DRUG

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role collaborator

Zimmer Biomet

INDUSTRY

Sponsor Role collaborator

St. Louis Joint Replacement Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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William C Schroer, MD

Role: PRINCIPAL_INVESTIGATOR

St. Louis Joint Replacement Institute

Locations

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DePaul Health Center

St Louis, Missouri, United States

Site Status

Countries

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United States

Other Identifiers

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GA3190YM

Identifier Type: -

Identifier Source: org_study_id

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