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The Effects of Celecoxib on Bone Ingrowth

This study has been terminated.
(New clinical finding with Celebrex and cardiac concerns.)
Information provided by (Responsible Party):
University of Utah Identifier:
First received: December 26, 2007
Last updated: March 11, 2016
Last verified: March 2016
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.

Condition Intervention Phase
Bone Ingrowth Pain Drug: Celecoxib Early Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: The Effects of Celecoxib on Bone Ingrowth in Porous Coated Titanium Ceramic Implants in Humans

Resource links provided by NLM:

Further study details as provided by University of Utah:

Primary Outcome Measures:
  • Bone Ingrowth [ Time Frame: 12 weeks ]

Secondary Outcome Measures:
  • Pain Score [ Time Frame: 10 days postoperative ]

Enrollment: 9
Study Start Date: June 2008
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm #1
Celebrex treatment group
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.
Other Name: Celebrex


Ages Eligible for Study:   18 Years to 95 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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.
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Please refer to this study by its identifier: NCT00585156

United States, Utah
Veteran Affairs (VA) Medical Center
Salt Lake City, Utah, United States, 84148
Sponsors and Collaborators
University of Utah
Principal Investigator: Roy Bloebaum, Ph.D. Research Professor, Orthopedic Surgery
  More Information

Responsible Party: University of Utah Identifier: NCT00585156     History of Changes
Other Study ID Numbers: IIR#2005-0300
Study First Received: December 26, 2007
Last Updated: March 11, 2016

Keywords provided by University of Utah:
Celebrex, Bone Ingrowth, Pain relief

Additional relevant MeSH terms:
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents processed this record on June 23, 2017