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Background: The use of a tourniquet during total knee arthroplasty (TKA) is controversial. Pain and return to function are believed, by some, to be influenced by the use of a tourniquet. The hypothesis of this study was that use of a tourniquet would delay postoperative functional recovery and increase pain as compared with no tourniquet use. Methods: Two hundred patients were recruited for this prospective, double-blinded, randomized controlled trial. Patients were randomized to undergo TKA either with a tourniquet (100 patients) or without one (100 patients) and blinded to group allocation. Primary outcome measures were functional assessment testing using the Timed Up & Go (TUG) test and visual analog scale (VAS) pain scores. Secondary outcome measures included the stair-climb test, blood loss, surgical field visualization, and range of motion. Outcome measures were completed preoperatively, in the hospital, and postoperatively at a first and a second follow-up. The minimal detectable change, Student t test, Fisher exact test, and nonasymptotic chi-square analysis with an alpha of p < 0.05 were used to determine significance. Results: The no-tourniquet group had more calculated blood loss (1,148.02 mL compared with 966.64 mL; p < 0.001) and more difficulty with surgical field visualization (p < 0.0001). The tourniquet group had greater knee extension at the first follow-up (−7° compared with −9°; p = 0.044). Conclusions: Tourniquet use during TKA significantly decreases blood loss and does not adversely affect early postoperative outcomes. Tourniquet use during routine TKA is safe and effective, and concerns about deleterious effects on function and pain may not be justified. Level of Evidence: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

Prognostic Level IV. See Instructions for Authors for a complete description of levels of evidence.