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: September 30, 2008
Verified by: University of Utah, September 2008
Clinical Trial Phase: Phase 4 | Start Date: June 2008
Overall Status: Terminated
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
Study Primary Completion Date: September 2008
Intervention(s) in this Clinical Trial
- Drug: 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.
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: Arm #1
- Celebrex treatment group
Outcome Measures for this Clinical Trial
Primary Measures
- Bone Ingrowth
- Time Frame: 12 weeks
Safety Issue?: No
- Time Frame: 12 weeks
Secondary Measures
- Pain Score
- Time Frame: 10 days postoperative
Safety Issue?: No
- Time Frame: 10 days postoperative
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.
Gender Eligibility for this Clinical Trial: Male
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 95 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers
Clinical Trial Sponsor Information
Lead Sponsor: University of Utah
Overall Clinical Trial Officials and Contacts
Roy Bloebaum, Ph.D. Principal Investigator Research Professor, Orthopedic Surgery
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 02, 2009
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
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