Celebrex Total Knee Arthroplasty Study

Viatris

Status and phase: Terminated; Phase 4

Conditions: Osteoarthritis; Pain

Treatments: Drug: Placebo; Drug: Celecoxib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00359151

A3191225

Details and patient eligibility

About

This study will investigate the benefits of administering celecoxib (Celebrex), a selective cyclooxygenase -2 (COX-2) inhibitor, in treating osteoarthritis (OA) subjects undergoing elective unilateral primary total knee arthroplasty (TKA) from the pre-operative phase to the management of post total knee replacement pain, and through the 6 weeks of physical therapy and rehabilitation.

Enrollment: 22 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The subject is a male or female 18 years or older with osteoarthritis of the knee scheduled to undergo elective unilateral primary total knee arthroplasty because of OA, performed under a standardized regimen of anesthesia and procedure.

Exclusion criteria

• Subject has a history of inflammatory arthritis (e.g. rheumatoid arthritis, ankylosing spondylitis) other than osteoarthritis.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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22 participants in 2 patient groups, including a placebo group

Celecoxib

Experimental group

Description:

Celecoxib

Treatment:

Drug: Celecoxib

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo