In addition to traditional posterior-stabilized (PS) designs with cam-post articulations, there are two new design concepts used in total knee replacement (TKR) to “substitute” for cruciate ligament function and restore anterior-posterior stability. These include i) guided-motion PS designs with a modified cam-post that is less restrictive to axial rotation; and ii) non-PS designs that incorporate progressive articular congruency to substitute the function of the resected anterior cruciate ligament (ACL-substituting). Early post-marketing surveillance of such new TKR designs is valuable because instability, loosening, and high complication rates within the initial 5 year follow-up interval have proven problematic for some design. This study reports the early clinical performance of sequential patients implanted with a new ACL-substituting TKR design at a German Center of Excellence for Arthroplasty (EPZ-Max) hospital. This is a single-site, multi-surgeon retrospective study with Institutional Review Board approval. The nine surgeons involved all used uniform surgical techniques, including a mid-vastus approach, PCL preservation with a bone block, tibial component alignment with the natural tibial slope, no patellar resurfacing, and cement fixation. All patients meeting the following inclusion criteria were contacted by phone: a) primary TKR from July 2008-June 2009; b) implanted with an ACL-substituting design (3D Knee™, DJO Surgical); c) no prior knee arthroplasty; and d) willing to consent to participate. Recorded outcomes at the 5 year follow-up interval included range of motion, Knee Society knee/function scores (KSS), and radiographic results (alignment, radiolucent lines, osteolysis). Additional surgery was classified as “revision” (metal components removed) or “reoperation” (metal components not removed).Introduction
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