The objective of this prospective duo-center study was to evaluate the clinical and radiological outcome of the unconstrained Multigen Plus total knee system (Lima Lto, San Daniele, Italy) with the new BIOLOXÒ Delta ceramic femoral component.

40 patients underwent cemented total knee arthroplasty in two university hospitals. Clinical evaluations were undertaken preoperatively and at 3 as well as 12 months postoperatively using the HSS-Score, WOMAC-Score and SF-36-Score. The radiological investigations included ant-post. radiographs (whole leg in two leg stance and lateral view of the knee) and patella tangential radiographs (Merchant view).

During 12 months follow-up three patients underwent revision surgery. One patient had to be revised due to infection after postoperative opening of the knee joint due to direct trauma. One patient sustained an osteosynthetic procedure due to periprosthetic fracture after trauma. In one patient a retropatellar replacement was inserted one year postoperatively. Implant related complications were not found. The mean preoperative HSS-Score amounted to 57.8±11.7 points. At 3 and 12 month follow-up the mean HSS-Score was 76.0±12.3 and 83.3±11.9 points respectively.

Therefore HSS, as well as WOMAC and SF-36 Score improved significantly from preoperativly to both postoperative evaluations (Wilcoxon-Test p< 0.002). Radio-lucent lines around the femoral ceramic component were found in six cases.

However, subsequent long-term studies must be carried out in order to prove the good early clinical results and to clarify if progression of radiolucent lines may influence the clinical outcome of the presented newly ceramic total knee system.