Retrospective Chart Analysis in the Effective Use of FloSeal in Post-Operative Joint Replacements
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - 95 |
| Updated: | 4/2/2016 |
| Start Date: | September 2009 |
| Contact: | Charles Z Cyr, BA |
| Email: | ccyr@desertortho.com |
| Phone: | 760-766-1227 |
Retrospective & Prospective Evaluation/Analysis of Hb/Hct in Patients Having Received FloSeal (5ml &10ml) When Undergoing Total Knee or Total Hip Arthroplasty
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.
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.
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.
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.
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
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