Retrospective Chart Analysis in the Effective Use of FloSeal in Post-Operative Joint Replacements

Study Overview
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Brief Summary
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The purpose of this analysis is to compare Hemoglobin and Hematocrit levels following total hip or knee arthroplasty. The utilization of FloSeal intraoperatively will improve hemostasis postoperatively. Decreasing bleeding time will decrease the drop in level of Hemoglobin and Hematocrit which usually occurs postoperatively.

Detailed Description
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Retrospective Analysis of charts on patients having undergone Total Hip or Total Knee Arthroplasty. During the patient's hospitalization, lab values of Hg and Hct will be recorded for further analysis. Preoperative levels will be also noted to establish baselines. 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.

Official Title
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Retrospective & Prospective Evaluation/Analysis of Hb/Hct in Patients Having Received FloSeal (5ml &10ml) When Undergoing Total Knee or Total Hip Arthroplasty

Conditions
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Total Knee Arthroplasty, Arthroplasty, Replacement, Hip

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Total Knee and Total Hip Patients Surgical Time less than 2 hours Exclusion Criteria: Patients who require greater than 2 hour surgeries Patients who are undergoing revision arthroplasty Patients with known allergies to materials of bovine origin

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| FloSeal - Knee - control<br>100 Historical Control Patients, knees - no FloSeal (retrospective) | |
| FloSeal - Knee - 5ml<br>100 Patients, knees - 5mL FloSeal (retrospective) | |
| FloSeal - Knee - 10ml<br>100 Patients, knees- 10mL FloSeal (prospective) | |
| FloSeal - Hip - Control<br>100 Historical Control patients, hips-no FloSeal (retrospective) | |
| FloSeal - Hip - 5ml<br>100 retrospective patients, hips-5mL of FloSeal (retrospective) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postoperative Hematocrit, Postoperative Hemoglobin