The Effects of Celecoxib on Bone Ingrowth

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.