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

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.