title: Early clinical results of a high-flexion, posterior-stabilized, mobile-bearing total knee arthroplasty: a US investigational device exemption trial.
abstract: 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.
authors.affiliation: Insall Scott Kelly Institute for Orthopaedics and Sports Medicine, New York, NY 10065, USA.
authors.forename: Giles R
authors.initials: GR
authors.lastname: Scuderi
authors.forename: David R
authors.initials: DR
authors.lastname: Hedden
authors.forename: John A
authors.initials: JA
authors.lastname: Maltry
authors.forename: Steven M
authors.initials: SM
authors.lastname: Traina
authors.forename: Mitchell B
authors.initials: MB
authors.lastname: Sheinkop
authors.forename: Mark A
authors.initials: MA
authors.lastname: Hartzband
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D019645:Arthroplasty, Replacement, Knee / Q000379:methods*; D005260:Female; D006801:Humans; D007720:Knee Prosthesis; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011474:Prosthesis Design; D016059:Range of Motion, Articular; D016037:Single-Blind Method; D013997:Time Factors; D016896:Treatment Outcome