ALGRX 4975 or placebo will be dripped onto the cut muscles and soft tissues before the end of
surgery for total replacement of the knee.
Each subject will undergo a screening visit; a hospitalization, during which total
replacement of the knee will be performed; and follow-up visits at 2, 6, and 12 weeks after
surgery. In addition, once discharged, subjects will be contacted by telephone daily up to
Day 14. Subjects will complete pain and medication diaries during the first 2 weeks following
surgery and will return these diaries at the 2 week visit.
Starting on the afternoon of Day 0 (the day of surgery), pain on active range of motion (ROM)
of the operated knee will be measured each morning at 8 AM ± 2 hours and each afternoon at 3
PM ± 3 hours. In addition, if the subject ambulates, pain with ambulation will be measured
during the first ambulation in the morning and during the first ambulation after noon.
Subjects will complete the Brief Pain Inventory - Short Form (BPI-SF) preoperatively, and at
the 2, 6, and 12 week visits. Subjects will be questioned regarding the use of assistive
devices (cane, walker, wheelchair, bedside commode, or other assistive devices) at screening,
at discharge, and at the 2, 6, and 12 week visits. The active ROM on flexion of the knee,
measured using a goniometer, will be recorded at screening and at the 2 week visit. Sensory
mapping of the knee will be performed at screening and at the 12 week visit.