Background: Customized cutting block (CCB) was designed to ensure the accurate alignment of knee prostheses during total knee arthroplasty. Given the paucity of CCB efficacy data, we compare CCB with conventional cutting guide using a randomized controlled trial.

Methods: One hundred eight osteoarthritic knee patients underwent total knee arthroplasty by one experienced surgeon were randomized to receive CCB (n = 54) or conventional cutting instrument (CCI) surgery (n = 54). The primary outcomes were limb alignment, prostheses position, and operative time. The secondary outcomes were hemodynamic alteration after surgery, functional outcomes (modified Western Ontario and McMaster University Osteoarthritis Index) and range of motion at 2 years after surgery.

Results: Mean hip-knee-ankle angle in the CCB group was 179.4° ± 1.8° vs 179.1° ± 2.4° in the CCI group, Δ = 0 (95% confidence interval [CI] -0.6 to 1.1, P = .55). Mean operative time was faster in the CCB arm: 93 ± 12 vs 104 ± 12 minutes, Δ = 11 (95% CI -16.7 to -7.2, P < .0001). There were no differences in hemodynamic parameters, mean blood loss (446 [CCB] vs 514 mL [CCI], Δ = -68 [95% CI -138 to 31 mL, P = .21]), postoperative hemoglobin changes, incidence of hypotension (systolic <90 mm Hg), oliguria, and rates of blood transfusion. Functional outcomes and range of motion were also similar.

Conclusion: There was no improvement in alignment, hemodynamic changes, blood loss, and knee functional outcomes. CCB reduced surgical time by 11 minutes in our population. CCB cost-effectiveness should be further investigated.