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Clinical Trials/NCT00585156
NCT00585156
Terminated
Early Phase 1

The Effects of Celecoxib on Bone Ingrowth in Porous Coated Titanium Ceramic Implants in Humans

University of Utah1 site in 1 country9 target enrollmentStarted: June 2008Last updated:
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ConditionsBone IngrowthPain
InterventionsCelecoxib

Overview

Phase
Early Phase 1
Status
Terminated
Enrollment
9
Locations
1
Primary Endpoint
Bone Ingrowth
OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Basic Science
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 95 Years (Adult, Older Adult)
Sex
Male
Accepts Healthy Volunteers
Yes

Inclusion Criteria

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

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.

Arms & Interventions

Arm #1

Experimental

Celebrex treatment group

Intervention: Celecoxib (Drug)

Outcomes

Primary Outcomes

Bone Ingrowth

Time Frame: 12 weeks

Secondary Outcomes

  • Pain Score(10 days postoperative)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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