The Effects of Celecoxib on Bone Ingrowth

Early Phase 1

Terminated

• Conditions: Bone Ingrowth; Pain
• Interventions: Drug: Celecoxib

• Registration Number: NCT00585156
• Lead Sponsor: University of Utah

Brief Summary

The purpose of this study is to evaluate the effect of Celebrex on bone growth into porous coated implants, following postoperative total knee arthroplasty administration of Celebrex for pain relief.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-12-26
• Study First Submitted QC: 2008-01-02
• Study First Posted: 2008-01-03
• Study Start: 2008-06
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-11
• Last Update Posted: 2016-03-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 9

Inclusion Criteria

• Male VA bilateral TKA patients 18 years or older with primary OA diagnosis

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Exclusion Criteria

• Patients with osteoporosis, hypersensitivity to Celebrex, allergy to tetracycline, Sulfonamides, patient with asthma, urticaria, or allergic-type reactions to aspirin or NSAIDs.
• Patients who have had CABG.
• Patients with a history of peptic ulcer disease, duodenal ulcers.
• Female patients and patients diagnosed with unstable hypertension or hypotensive, with serum creative levels above 1.8-2.0 or diagnosed with severe renal disease.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm #1	Celecoxib	Celebrex treatment group

Primary Outcome Measures

Name	Time	Method
Bone Ingrowth	12 weeks

Secondary Outcome Measures

Name	Time	Method
Pain Score	10 days postoperative

Trial Locations

Locations (1)

Veteran Affairs (VA) Medical Center; 🇺🇸 Salt Lake City, Utah, United States