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

Phase 4

Completed

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.

Detailed 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.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
Hemostatic Matrix	Hemostatic Matrix	2 vials of Floseal applied once at the end of surgery

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Range of Motion on Day 3	3days postoperatively
Visual Analog Pain Scale on Day 3	3 days postoperatively	A VAS is a measurement instrument that tries to measure a characteristic or attitude that cannot easily be measured. The pain VAS scale measures pain intensity on a scale of 0 to 10, with 0=no pain. A higher score indicates greater pain intensity.
Range of Motion at Six Weeks	6 weeks postoperatively
Visual Analog Pain Scale at 6 Weeks	6 weeks postoperatively	A VAS is a measurement instrument that tries to measure a characteristic or attitude that cannot easily be measured. The pain VAS scale measures pain intensity on a scale of 0 to 10, with 0=no pain. A higher score indicates greater pain intensity.