Randomized Controlled Trial of a Novel Cementless vs. Cemented Total Knee Arthroplasty: Early Clinical and Radiographic Outcomes.

研究概要

Sixty-four patients with primary knee osteoarthritis were randomized to receive a cementless 3D-printed trabecular-metal PS TKA with a tibial mechanical-locking claw (n=30) or a conventional cemented PS TKA (n=34). The primary outcome was Knee Society Score (KSS, knee and function); secondary outcomes included ROM, WOMAC (pain/function), radiographic alignment parameters, radiolucent lines/osteolysis by radiograph/CT, and complications including revision. Outcomes were assessed at 6 and 12 months. Overall, the results showed no between-group differences in KSS or other clinical metrics, and radiographic fixation/alignment and complication rates were comparable; one periprosthetic joint infection in the cementless group required two-stage revision. These early data suggest the novel cementless design achieves clinical and radiographic results comparable to cemented fixation at 1 year.