Total Knee Replacement
Conditions
Brief 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.
Interventions
DRUGFondaparinux Sodium (Arixtra)
2.5 mg once per day to begin 6-8 hours after surgery and continued for 10 days.
Sponsors
Paul Di Cesare,MD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Days Until a Dry Wound | Up to 10 days | Days from day of surgery to stoppage of leakage from the wound |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Days in Hospital. | Up to 10 days | Days after surgery to dischage |
| Incidence of Wound Infection | Up to 10 days | Incidence of Cellulitis in patients undergoing Arixtra treatment |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Arixtra Effect of Arixtra on would drainage and length of stay for the patients with hip and knee replacement
Fondaparinux Sodium (Arixtra): 2.5 mg once per day to begin 6-8 hours after surgery and continued for 10 days. | 114 |
| Total | 114 |
Baseline characteristics
| Characteristic | Arixtra |
|---|---|
| Age, Continuous | 61.7 years STANDARD_DEVIATION 9.4 |
| Sex: Female, Male Female | 66 Participants |
| Sex: Female, Male Male | 48 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 114 |
| other Total, other adverse events | 2 / 114 |
| serious Total, serious adverse events | 0 / 114 |
Outcome results
Primary
Number of Days Until a Dry Wound
Days from day of surgery to stoppage of leakage from the wound
Time frame: Up to 10 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arixtra | Number of Days Until a Dry Wound | 3.6 days | Standard Deviation 2.2 |
Secondary
Incidence of Wound Infection
Incidence of Cellulitis in patients undergoing Arixtra treatment
Time frame: Up to 10 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arixtra | Incidence of Wound Infection | 2 Participants |
Secondary
Number of Days in Hospital.
Days after surgery to dischage
Time frame: Up to 10 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arixtra | Number of Days in Hospital. | 3.73 days | Standard Deviation 1.4 |