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

Desert Orthopedic Center Medical Research Foundation

Status: Unknown

Conditions: Arthroplasty, Replacement, Hip; Total Knee Arthroplasty

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT00958945

FloSeal

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18 to 95 years old

Volunteers: No Healthy Volunteers

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

Trial design

500 participants in 5 patient groups

FloSeal - Knee - control

Description:

100 Historical Control Patients, knees - no FloSeal (retrospective)

FloSeal - Knee - 5ml

Description:

100 Patients, knees - 5mL FloSeal (retrospective)

FloSeal - Knee - 10ml

Description:

100 Patients, knees- 10mL FloSeal (prospective)

FloSeal - Hip - Control

Description:

100 Historical Control patients, hips-no FloSeal (retrospective)

FloSeal - Hip - 5ml

Description:

100 retrospective patients, hips-5mL of FloSeal (retrospective)