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

Total Knee Arthroplasty Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00958945
• Other study ID #: FloSeal
• Status: Not yet recruiting
• Phase: N/A
• First received: August 12, 2009
• Last updated: August 13, 2009
• Start date: September 2009

Study information

• Verified date: August 2009
• Source: Desert Orthopedic Center Medical Research Foundation
• Contact: Charles Z Cyr, BA
• Phone: 760-766-1227
• Email: ccyr[@]desertortho.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 95 Years

Eligibility

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

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Arthroplasty, Replacement, Hip
• Total Knee Arthroplasty

Locations

Country	Name	City	State
United States	Desert Orthopedic Center	Rancho Mirage	California

Sponsors (2)

Lead Sponsor	Collaborator
Desert Orthopedic Center Medical Research Foundation	Baxter Healthcare Corporation

Country where clinical trial is conducted

United States,