The Use of FLOSEAL to Reduce Bleeding in Total Knee Replacement Surgery

Hospital for Special Surgery (HSS)

Status and phase: Completed; Phase 4

Conditions: Blood Loss

Treatments: Drug: Hemostatic Matrix

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00990288

26078

Details and patient eligibility

About

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.

Full description

This is a prospective double blind randomized clinical trial of patients requiring unilateral total knee arthroplasty. The patients will be randomized intra-operatively to receiving Floseal or no treatment.

Both the patient and the observers will be blinded to whether the subject received Floseal or no treatment. Only the operating surgeons will be aware of whether Floseal or no treatment was given.

As was performed in the pilot study, randomization of Floseal or no treatment will be performed using the sealed envelope technique. Randomization will occur at the time of surgery. The statistician is responsible for maintaining the randomization schedule and issuing the sealed envelopes. The inner envelope will contain whether Floseal or no treatment is to be given on a card which will be counter-signed by the surgeon at the time of surgery. The inner envelope will then be sealed, followed by sealing of the outer envelope. Following the procedure, the surgeon will then take the sealed and signed envelope to surgeon who will store and file it in a locked cabinet in his office. The patients study number will be on the outside surface of the envelopes.

Enrollment: 196 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Single Knee replacement for arthritis of the knee

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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196 participants in 2 patient groups

Hemostatic Matrix

Experimental group

Description:

2 vials of Floseal applied once at the end of surgery

Treatment:

Drug: Hemostatic Matrix

Control

No Intervention group

Description:

No intervention.