The Effects of Celecoxib on Bone Ingrowth
Information source: University of Utah
Information obtained from ClinicalTrials.gov on August 08, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bone Ingrowth; Pain
Intervention: Celecoxib (Drug)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: University of Utah Official(s) and/or principal investigator(s):
Roy Bloebaum, Ph.D., Principal Investigator, Affiliation: Research Professor, Orthopedic Surgery
Overall contact:
Amie M Tanner, BS, Phone: (801) 582-1565, Ext: 4607, Email: amie.tanner@hsc.utah.edu
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.
Clinical Details
Official title: The Effects of Celecoxib on Bone Ingrowth in Porous Coated Titanium Ceramic Implants in Humans
Study design: Basic Science, Single Blind (Outcomes Assessor), Historical Control, Single Group Assignment, Efficacy Study
Primary outcome: Bone Ingrowth
Secondary outcome: Pain Score
Eligibility
Minimum age: 18 Years.
Maximum age: 95 Years.
Gender(s): Male.
Criteria:
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.
Locations and Contacts
Amie M Tanner, BS, Phone: (801) 582-1565, Ext: 4607, Email: amie.tanner@hsc.utah.edu
Veteran Affairs (VA) Medical Center, Salt Lake City, Utah 84148, United States; Not yet recruiting
Amie M Tanner, BS, Phone: 801-582-1565, Ext: 4607, Email: amie.tanner@hsc.utah.edu
Roy D Bloebaum, Ph.D., Principal Investigator
Additional Information
Related publications: 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. 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.
Starting date: June 2008
Ending date: May 2009
Last updated: January 2, 2008
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