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Status unknownNCT00958945Updated Aug 14, 2009

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

An observational study in Total Knee Arthroplasty and Arthroplasty, Replacement, Hip, sponsored by Desert Orthopedic Center Medical Research Foundation. Status unknown at 1 site in United States. Open to participants aged 18 Years to 95 Years. Per ClinicalTrials.gov, last updated 2009-08-14.

Sponsored by Desert Orthopedic Center Medical Research Foundation · Observational

The sponsor has not verified this record recently (last verified Aug 2009), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Time perspective
Retrospective
Enrollment
500
Ages
18 Years to 95 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Total Knee Arthroplasty
  • Arthroplasty, Replacement, Hip

Keywords

  • Postoperative Hematocrit
  • Postoperative Hemoglobin
03

In context

Lead sponsor

This is the only study on the registry with Desert Orthopedic Center Medical Research Foundation as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 95 Years
Sexes eligible
All
Accepts healthy volunteers
No
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

Inclusion criteria

  • Total Knee and Total Hip Patients
  • Surgical Time less than 2 hours

Exclusion criteria

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
05

Study design

Time perspective
Retrospective
Enrollment
500 participants (estimated)

Groups and cohorts

  • 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)

06

Study locations

1 site
  • Desert Orthopedic Center
    Rancho Mirage, California 92211, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 14, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00958945
Lead sponsor
Desert Orthopedic Center Medical Research Foundation
Collaborators
Baxter Healthcare Corporation
First posted
Aug 14, 2009
Start date
Sep 2009
Last update
Aug 14, 2009

Study contacts

Charles Z Cyr, BA
Contact
ccyr@desertortho.com
760-766-1227
John H. Velyvis,, MD
principal investigator · Desert Orthopedic Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2009. You cannot join it, but the record below documents what was studied.

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