Early clinical results of a high-flexion, posterior-stabilized, mobile-bearing total knee arthroplasty: a US investigational device exemption trial.

Between May 2001 and June 2004, 388 total knee arthroplasty cases were enrolled in a prospective, randomized, multicenter investigational device exemption trial. Patients received either the investigational high-flexion mobile-bearing knee or a fixed-bearing control. At 2 to 4 years of follow-up, results in 293 patients with degenerative joint disease were compared using Knee Society Assessment and Function scores, radiographic results, complications analysis, and survival estimates. The mobile-bearing and fixed-bearing groups demonstrated similar, significant improvement over preoperative assessments in Knee Scores, maximum flexion, and range of motion. One mobile-bearing arthroplasty required revision. Radiographic results were unremarkable, and implant-related complications were rare in both groups. At this early follow-up, the investigational high-flexion mobile-bearing knee and its fixed-bearing counterpart demonstrated comparable, effective performance. Copyright Â

RCT Entities:   Population Interventions Outcomes