The Effects of Celecoxib on Bone Ingrowth

Pain Clinical Trial

Official title:

The Effects of Celecoxib on Bone Ingrowth in Porous Coated Titanium Ceramic Implants in Humans

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00585156
• Other study ID #: IIR#2005-0300
• Secondary ID: IIR#2005-0300
• Status: Terminated
• Phase: Phase 0
• First received: December 26, 2007
• Last updated: March 11, 2016
• Start date: June 2008
• Est. completion date: September 2008

Study information

• Verified date: March 2016
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 95 Years

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Bone Ingrowth
• Pain

Intervention

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.

Locations

Country	Name	City	State
United States	Veteran Affairs (VA) Medical Center	Salt Lake City	Utah

Sponsors (2)

Lead Sponsor	Collaborator
University of Utah	Pfizer

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone Ingrowth		12 weeks	No
Secondary	Pain Score		10 days postoperative	No