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

NCT ID: NCT00958945

Last Updated: 2009-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Total Knee Arthroplasty Arthroplasty, Replacement, Hip

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

FloSeal - Knee - control

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

No interventions assigned to this group

FloSeal - Knee - 5ml

100 Patients, knees - 5mL FloSeal (retrospective)

No interventions assigned to this group

FloSeal - Knee - 10ml

100 Patients, knees- 10mL FloSeal (prospective)

No interventions assigned to this group

FloSeal - Hip - Control

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

No interventions assigned to this group

FloSeal - Hip - 5ml

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

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Baxter Healthcare Corporation

INDUSTRY

Sponsor Role collaborator

Desert Orthopedic Center Medical Research Foundation

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Desert Orthopedic Center Medical Research Foundation

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

John H. Velyvis,, MD

Role: PRINCIPAL_INVESTIGATOR

Desert Orthopedic Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Desert Orthopedic Center

Rancho Mirage, California, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Charles Z Cyr, BA

Role: CONTACT

760-766-1227

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

FloSeal

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.