BACKGROUND: Total knee arthroplasty is the most effective method for the treatment of end-stage knee osteoarthritis, but whether to use tourniquets during total knee arthroplasty remains controversial in academic circles. OBJECTIVE: To investigate the effect of tourniquet on postoperative clinical efficacy and imaging results during total knee arthroplasty. METHODS: From September 2019 to September 2020, a prospective, randomized, controlled study was conducted in patients who underwent primary total knee arthroplasty for degenerative osteoarthritis. All patients were treated with cement-based prosthesis of the same design, and were randomly divided into intraoperative tourniquet use group (control group) and no tourniquet use group (trial group). To make clinical data comparable, the same follow-up time point was set for both groups, 12 months after surgery. A total of 100 cases (49 cases in the trial group; 51 cases in the control group) were included in the final analysis to evaluate the clinical efficacy, penetration depth of bone cement, and incidence of postoperative complications. RESULTS AND CONCLUSION: (1) The operation was successfully completed in both groups. The release rate of external patellar retinacular band was lower in the trial group (0 cases) than that in the control group (6 cases) (P=0.040). (2) The visual analogue scale score of the trial group on the 7th postoperative day was lower than that of the control group (P=0.00). Visual analogue scale score between the trial group and the control group had no statistical significance 1 month after surgery (P=0.61). (3) There was no significant difference in the range of motion at 12 months and KSS score at 1 month between the trial group and the control group. (4) X-ray examination 2 days after the operation showed that the penetration depth of bone cement was similar between the two groups (P=0.281). (5) At 12 months after the operation, there was no periprosthetic infection, prosthesis loosening or symptomatic thrombosis in both groups. (6) It is indicated that whether to use tourniquets during primary total knee arthroplasty does not affect penetration depth of bone cement or clinical effect. However, the use of tourniquet can increase the degree of pain within 7 days after operation and the release rate of external patellar retinacular band. [ABSTRACT FROM AUTHOR]