SUMMARY A prospective, randomized, single-blinded clinical trial is proposed to compare
three tibial tray designs for patients undergoing total knee arthroplasty. This study is
designed to address the clinically important issues of tibial component modularity and
fixation in total knee replacement. The Zimmer NexGen Legacy knee system is an FDA approved
device and in this study will be used with 1) a modular tibial tray inserted with cement and
2) a non-modular tibial tray inserted with cement, and 3) a non-modular tibial tray inserted
without cement. The insertion of total knee components without cement has been done
clinically for over 20 years but has not been specifically approved by the FDA. Thus
treatment arm 3, a non-modular tray inserted without cement, would involve the so-called
off-label use of the device.
136 cases will be assigned to each arm of the study. Each patient will be assessed two
months after surgery, one year after surgery, two years after surgery, five years after
surgery, and every three to five years thereafter. The principal outcome measures will be
the Knee Society Clinical rating scale, the SF-36 and the presence of significant lucent
lines.. These measures will be compared among patients in the 3 trial arms at 5 years post
surgery (or at the last follow-up point for those who drop out or become lost to follow-up).
The Knee Society scores and SF-36 scores will be analyzed using analysis of variance models
Rates of significant lucencies, perioperative mortality, as well as complications such as
deep vein thrombosis, pulmonary embolus, neurovascular complication, and infection will be
compared among the groups using chi-square tests . Rates of revision surgery will be
compared among the groups using survivorship methods.
PURPOSE The primary aim of the study is to compare the results obtained with each of three
tibial designs for patients undergoing total knee arthroplasty. Those results will be
measured with disease-specific (Knee Society Scores), global (SF-36), and outcome measures.
Radiographic results consisting of standing alignment, lateral and skyline views of the
surgical knee will be recorded and analyzed. Completion of the intial investigation will
occur at the 5-year interval after the last enrolled patient.
- Patients greater then or equal to 20 and less then or equal to 85 undergoing
unilateral primary knee surgery for degenerative joint disease (DJD).
- Age less than 20 years or > 85.
- Severe deformity great then or equal to 20 degrees varus, valgus malalignment or
- Osteomyelitis, septicemia, prior infection of knee joint, or other active infections
that may spread to other areas of the body.
- The presence of infections, highly communicable diseases, e.g. AIDS, active
tuberculosis, venereal disease, and hepatitis.
- Significant neurological or musculoskeletal disorders or disease that may adversely
affect normal gait or weight bearing.
- Metastatic disease.
- Any congenital, developmental, or other bone disease or previous knee surgery that
may, in the surgeon's judgement, interfere with TK prosthesis survival or success,
e.g. Paget's disease, Charcot's disease secondary to diabetes, severe osteoporosis,
previous high tibial osteotomy, etc.
- Presence of previous prosthetic knee replacement device (any type).
- Arthrodesis of the affected knee.
- Patients not requiring patella resurfacing.