Retrospective Chart Analysis in the Effective Use of FloSeal in Post-Operative Joint Replacements
NCT ID: NCT00958945
Last Updated: 2009-08-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
500 participants
OBSERVATIONAL
2009-09-30
Brief Summary
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Detailed Description
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Primary Data interest will be Hemoglobin (Hgb) level documented during hospitalization along with Hematocrit (HCT) and Red Blood Cell (RBC) data also collected.
Secondary Data gathered will consist of the following:
* patient Demographics
* Component Profile
* Length of Stay
* Anesthesia used
* Anesthesiologist
* EBL
* drain type
* Amount of drainage fluid recorded at 12 hour increments until discharge
* Amount of FloSeal used
* Type of Arthroplasty
500 patients in Total
* 100 Historical Control Patients, knees - no FloSeal (retrospective)
* 100 Patients, knees - 5mL FloSeal (retrospective)
* 100 Patients, knees- 10mL FloSeal (prospective)
* 100 Historical Control patients, hips-no FloSeal (retrospective)
* 100 retrospective patients, hips-5mL of FloSeal (retrospective
Patients scheduled for Total Knee Arthroplasty will be asked if they wish to participate in the part of the study utilizing 10mL of FloSeal. These patient will be consented and the their data will be retrospectively gathered.
Conditions
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Study Design
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RETROSPECTIVE
Study Groups
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FloSeal - Knee - control
100 Historical Control Patients, knees - no FloSeal (retrospective)
No interventions assigned to this group
FloSeal - Knee - 5ml
100 Patients, knees - 5mL FloSeal (retrospective)
No interventions assigned to this group
FloSeal - Knee - 10ml
100 Patients, knees- 10mL FloSeal (prospective)
No interventions assigned to this group
FloSeal - Hip - Control
100 Historical Control patients, hips-no FloSeal (retrospective)
No interventions assigned to this group
FloSeal - Hip - 5ml
100 retrospective patients, hips-5mL of FloSeal (retrospective)
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Surgical Time less than 2 hours
Exclusion Criteria
* Patients who are undergoing revision arthroplasty
* Patients with known allergies to materials of bovine origin
18 Years
95 Years
ALL
No
Sponsors
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Baxter Healthcare Corporation
INDUSTRY
Desert Orthopedic Center Medical Research Foundation
OTHER
Responsible Party
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Desert Orthopedic Center Medical Research Foundation
Principal Investigators
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John H. Velyvis,, MD
Role: PRINCIPAL_INVESTIGATOR
Desert Orthopedic Center
Locations
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Desert Orthopedic Center
Rancho Mirage, California, United States
Countries
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Central Contacts
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Other Identifiers
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FloSeal
Identifier Type: -
Identifier Source: org_study_id
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