The Effects of Celecoxib on Bone Ingrowth

NCT00585156 | Terminated Early Phase 1

• 1 other identifier: IIR#2005-0300
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bone Ingrowth; Pain

Keywords

Celebrex, Bone Ingrowth, Pain relief

Outcome Measures

Primary Outcomes (1)

• Bone Ingrowth

  12 weeks

Secondary Outcomes (1)

• Pain Score

  10 days postoperative

Study Arms (1)

Arm #1

EXPERIMENTAL

Celebrex treatment group

Drug: Celecoxib

Interventions

Celecoxib DRUG

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.

Also known as: Celebrex

Arm #1

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male VA bilateral TKA patients 18 years or older with primary OA diagnosis

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Utah: lead
• Pfizer: collaborator

Study Sites (1)

Veteran Affairs (VA) Medical Center

Salt Lake City, Utah, 84148, United States

Location

Related Publications (2)

• 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. doi: 10.1007/BF00189618.

  PMID: 1473888 BACKGROUND

• 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. doi: 10.1097/01.blo.0000238838.18799.61.

  PMID: 17016230 BACKGROUND

MeSH Terms

Conditions

Pain

Interventions

Celecoxib

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Roy Bloebaum, Ph.D.

  Research Professor, Orthopedic Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2007
• First Posted: January 3, 2008
• Study Start: June 1, 2008
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: March 14, 2016

Record last verified: 2016-03

Locations

US (1)