NCT00990288

Brief Summary

The purpose of this study is to determine if the agent, Floseal, can decrease the amount of blood patients lose after total knee replacement (TKR) surgery. If this product can be found to have an effect on bleeding, it may potentially reduce the problems associated with bleeding after knee replacement surgery such as pain, stiffness, and the need to have a blood transfusion. The subject's overall participation will be over a period of 6 weeks.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
196

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Oct 2007

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

October 5, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 6, 2009

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
7.4 years until next milestone

Results Posted

Study results publicly available

December 12, 2017

Completed
Last Updated

December 12, 2017

Status Verified

November 1, 2017

Enrollment Period

2.8 years

First QC Date

October 5, 2009

Results QC Date

February 4, 2013

Last Update Submit

November 10, 2017

Conditions

Blood Loss

Keywords

To decrease blood loss during knee surgery

Outcome Measures

Primary Outcomes (9)

  • Change in Hemoglobin on Day 0 Compared to Preoperatively

    preoperatively and on the day of surgery

  • Change in Hemoglobin on Day 0 Compared to Preoperatively

    preoperatively and day of surgery

  • Change in Hemoglobin On Day 1 Compared to Preoperatively

    preoperatively and one day after surgery

  • Change in Hematocrit on Day 1 Compared to Preoperatively

    preoperatively and 1 day after surgery

  • Change in Hemoglobin on Day 2 Compared to Preoperatively

    preoperatively and two days after surgery

  • Change in Hematocrit on Day 2 Compared to Preoperatively

    preoperatively and two days after surgery

  • Drain Output

    24 hours postoperatively

  • Autologous Amount of Transfusion

    three days postoperatively

  • Homologous Amount of Transfusion

    three days postoperatively

Secondary Outcomes (4)

  • Range of Motion on Day 3

    3days postoperatively

  • Visual Analog Pain Scale on Day 3

    3 days postoperatively

  • Range of Motion at Six Weeks

    6 weeks postoperatively

  • Visual Analog Pain Scale at 6 Weeks

    6 weeks postoperatively

Study Arms (2)

Hemostatic Matrix

EXPERIMENTAL

2 vials of Floseal applied once at the end of surgery

Drug: Hemostatic Matrix

Control

NO INTERVENTION

No intervention.

Interventions

Hemostatic MatrixDRUG

FloSeal will be administered following the cementing of all knee components. Prior to release of the tourniquet and after the cement has cured, it will be applied to cut, exposed bone ends as well as the intra-articular soft tissues by the use of a delivery syringe, Direct manual pressure with a gauze sponge will be applied following its application for 2 minutes, ensuring that it adheres to the bleeding bone surface.

Also known as: "FloSeal", a thrombin and collagen based agent
Hemostatic Matrix

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Single Knee replacement for arthritis of the knee

You may not qualify if:

  • No inflammatory arthritis (ie. Rheumatoid arthritis)
  • No allergies to cow meat (bovine allergies
  • No history of bleeding disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital for Special Surgery

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Hemorrhage

Interventions

FloSeal Matrix

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Mark P. Figgie MD
Organization
Hospital for Special Surgery
figgiem@hss.edu
212-606-1932

Study Officials

  • Mark P Figgie, MD

    Hospital for Special Surgery, New York

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 5, 2009

First Posted

October 6, 2009

Study Start

October 1, 2007

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

December 12, 2017

Results First Posted

December 12, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)