The Effects of Arixtra on Wound Drainage Following Total Joint Arthroplasty

Total Knee Replacement Clinical Trial

Official title:

The Effects of Arixtra on Wound Drainage Following Total Joint Arthroplasty

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00909064
• Other study ID #: 200816251-2
• Secondary ID: GSK576428
• Status: Not yet recruiting
• Phase: Phase 4
• First received: May 22, 2009
• Last updated: May 26, 2009
• Start date: June 2009
• Est. completion date: December 2011

Study information

• Verified date: May 2009
• Source: University of California, Davis
• Contact: Anto Fritz, M D
• Phone: 925 785 0826
• Email: atfritz[@]ucdavis.edu
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The investigators hypothesize that Arixtra patients will be less likely to experience wound infection than patients who have received low-molecular weight heparin, coumadin or aspirin with mechanical compression.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 91
• Est. completion date: December 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• All primary unilateral TKA and THA cases will be included.

Exclusion Criteria:

• Patients less than 50 kg, Patients with CrCl<30ml/min. Revision and bilateral procedures will be excluded.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Total Knee Replacement

Intervention

Drug:
• Fondaparinux Sodium (Arixtra)
2.5 mg once per day to begin 6-8 hours after surgery and continued for 10 days.

Locations

Country	Name	City	State
United States	U C Davis	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of days until a dry wound		2 years	Yes
Secondary	1.Number of days in hospital. 2.Incidence of wound infection.		2 years	Yes