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

August 13, 2009 updated by: Desert Orthopedic Center Medical Research Foundation

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.

Study Overview

Status

Unknown

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Rancho Mirage, California, United States, 92211
        • Desert Orthopedic Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All Dr. Velyvis's patients that have had a Total Knee or Total Hip after January 1, 2007

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
FloSeal - Knee - control
100 Historical Control Patients, knees - no FloSeal (retrospective)
FloSeal - Knee - 5ml
100 Patients, knees - 5mL FloSeal (retrospective)
FloSeal - Knee - 10ml
100 Patients, knees- 10mL FloSeal (prospective)
FloSeal - Hip - Control
100 Historical Control patients, hips-no FloSeal (retrospective)
FloSeal - Hip - 5ml
100 retrospective patients, hips-5mL of FloSeal (retrospective)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Desert Orthopedic Center Medical Research Foundation

Collaborators

Baxter Healthcare Corporation

Investigators

  • Principal Investigator: John H. Velyvis,, MD, Desert Orthopedic Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Study Registration Dates

First Submitted

August 12, 2009

First Submitted That Met QC Criteria

August 13, 2009

First Posted (Estimate)

August 14, 2009

Study Record Updates

Last Update Posted (Estimate)

August 14, 2009

Last Update Submitted That Met QC Criteria

August 13, 2009

Last Verified

August 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • FloSeal

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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