The Effects of Celecoxib on Bone Ingrowth

NCT ID: NCT00585156

Last Updated: 2016-03-14

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

TERMINATED

Clinical Phase

EARLY_PHASE1

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2008-09-30

Brief Summary

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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

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Conditions

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Bone Ingrowth Pain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Arm #1

Celebrex treatment group

Group Type EXPERIMENTAL

Celecoxib

Intervention Type DRUG

Twelve hours prior to their first total knee surgery, patients will need to take an oral dose of Celebrex, 1 pill of 200mg. Following the patient's first total knee surgery, they will continue taking oral doses of Celebrex, 1 pill of 200 mg every twenty-four hours (200mg/day) for a two-week period.

Interventions

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Celecoxib

Twelve hours prior to their first total knee surgery, patients will need to take an oral dose of Celebrex, 1 pill of 200mg. Following the patient's first total knee surgery, they will continue taking oral doses of Celebrex, 1 pill of 200 mg every twenty-four hours (200mg/day) for a two-week period.

Intervention Type DRUG

Other Intervention Names

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Celebrex

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

95 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Pfizer

INDUSTRY

Sponsor Role collaborator

University of Utah

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Roy Bloebaum, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Research Professor, Orthopedic Surgery

Locations

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Veteran Affairs (VA) Medical Center

Salt Lake City, Utah, United States

Site Status

Countries

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United States

References

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Hofmann AA, Bloebaum RD, Rubman MH, Bachus KN, Plaster RL. Microscopic analysis of autograft bone applied at the interface of porous-coated devices in human cancellous bone. Int Orthop. 1992;16(4):349-58. doi: 10.1007/BF00189618.

Reference Type BACKGROUND
PMID: 1473888 (View on PubMed)

Hofmann AA, Bloebaum RD, Koller KE, Lahav A. Does celecoxib have an adverse effect on bone remodeling and ingrowth in humans? Clin Orthop Relat Res. 2006 Nov;452:200-4. doi: 10.1097/01.blo.0000238838.18799.61.

Reference Type BACKGROUND
PMID: 17016230 (View on PubMed)

Other Identifiers

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IIR#2005-0300

Identifier Type: -

Identifier Source: secondary_id

IIR#2005-0300

Identifier Type: -

Identifier Source: org_study_id

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