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...
Date First Received: December 26, 2007
Last Updated: January 2, 2008
Verified by: University of Utah, December 2007
Clinical Trial Phase: Phase 4 | Start Date: June 2008
Overall Status: Not yet recruiting
Estimated Enrollment: 9
Brief Summary
Official Title: “The Effects of Celecoxib on Bone Ingrowth in Porous Coated Titanium Ceramic Implants in Humans”
Condition Keyword(s):
Intervention(s):
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 Type: Interventional
Study Design: Basic Science, Single Blind (Outcomes Assessor), Historical Control, Single Group Assignment, Efficacy Study
Outcome Measures for this Clinical Trial
Primary:
- Bone Ingrowth 12 weeks No
Secondary:
- Pain Score 10 days postoperative No
Criteria for Participation in this Clinical Trial
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.
Clinical Trials Locations, Contact Details, and Sponsors
Lead Sponsor: University of Utah
Veteran Affairs (VA) Medical Center
Salt Lake City Utah 84148 United States
Overall Clinical Trial Officials and Contacts
Roy Bloebaum, Ph.D. Principal Investigator Research Professor, Orthopedic Surgery
Overall Contact: Amie M Tanner, BS (801) 582-1565 amie.tanner@hsc.utah.edu
Related Publications
References
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.
Additional Information
Information obtained from ClinicalTrials.gov on July 18, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00585156
Study ID Number: IIR#2005-0300
ClinicalTrials.gov Identifier: NCT00585156
Health Authority: United States: Food and Drug Administration
Clinical Trials Authorship and Review
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
