Total Knee ReplacementPhase 4NCT00909064
The Effects of Arixtra on Wound Drainage Following Total Joint Arthroplasty
A Phase 4 study testing Fondaparinux Sodium (Arixtra) in people with Total Knee Replacement, run by Paul Di Cesare,MD at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Total Knee Replacement
- What is being tested?
- Fondaparinux Sodium (Arixtra)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Dec 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All primary unilateral TKA and THA cases will be included.
Who cannot join
- Patients less than 50 kg, Patients with CrCl<30ml/min. Revision and bilateral procedures will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Total Knee Replacement
- Being tested
- Fondaparinux Sodium (Arixtra)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fondaparinux Sodium (Arixtra)Drug
Also called Arixtra
2.5 mg once per day to begin 6-8 hours after surgery and continued for 10 days.
| Study group | Role | What they receive |
|---|---|---|
| Arixtra | Experimental | Effect of Arixtra on would drainage and length of stay for the patients with hip and knee replacement Receives: Drug: Fondaparinux Sodium (Arixtra) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Days Until a Dry Wound
Days from day of surgery to stoppage of leakage from the wound
Measured: Up to 10 days
Secondary outcomes (2)
Number of Days in Hospital.
Days after surgery to dischage
Measured: Up to 10 days
Incidence of Wound Infection
Incidence of Cellulitis in patients undergoing Arixtra treatment
Measured: Up to 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2009 (estimated)
- Study startJun 2009
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Total Knee ReplacementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Paul Di Cesare,MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Paul Di Cesare,MD, University of California, Davis
- Investigators
- Paul E. DiCesare, MD, Principal investigator, University of California, Davis Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00909064
- Sponsor's protocol ID
- 200816251
- Other IDs
- GSK576428
- Status last verified
- May 2009
- First submitted
- 22 May 2009
- Last updated
- 15 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Arixtra on Wound Drainage Following Total Joint Arthroplasty
- ClinicalTrials.gov ID
- NCT00909064
- Acronym / sponsor ID
- 200816251
- Conditions
- Total Knee Replacement
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Paul Di Cesare,MDUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 27 May 2009 (estimated)
- Results
- Posted 15 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arixtra | Experimental | Drug: Fondaparinux Sodium (Arixtra)Effect of Arixtra on would drainage and length of stay for the patients with hip and knee replacement |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All primary unilateral TKA and THA cases will be included.
Key exclusion criteria (1 listed)
- Patients less than 50 kg, Patients with CrCl<30ml/min. Revision and bilateral procedures will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fondaparinux Sodium (Arixtra)Also: Arixtra2.5 mg once per day to begin 6-8 hours after surgery and continued for 10 days. | Drug | Arixtra |
Primary outcome
Number of Days Until a Dry Wound
Time frame: Up to 10 days
Days from day of surgery to stoppage of leakage from the wound
2 secondary outcomes
Number of Days in Hospital.
Time frame: Up to 10 days
Incidence of Wound Infection
Time frame: Up to 10 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul E. DiCesare, MD principal investigator
University of California, Davis Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fondaparinux Sodium (Arixtra) in people with Total Knee Replacement, run by Paul Di Cesare,MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Days Until a Dry Wound (time frame: Up to 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2017.