A PROSPECTIVE RANDOMIZED CONTROLLED TRIAL USING ROENTGEN STEREOPHOTOGRAMMERTRIC ANALYSIS OF THE ADVANCE MEDICAL PIVOT KNEE: 2 YEAR RESULTS

Abstract

Purpose: To investigate the stability of an uncemented Trabecular Metal (TM) tibial component we used maximum total point motion (MTPM) as determined with RSA to compare micromotion at the tibial component/bone interface between the uncemented Nexgen TM monoblock and cemented Nexgen cobalt chrome modular knee prostheses.

Methods: A power calculation determined that a minimum sample size of 40 (20/group) was required. Sixty-seven patients with primary osteoarthritis of the knee were randomized to receive the Nexgen TM monoblock (n=34; 20 female; mean age=66 years; mean BMI=32) or cobalt chrome modular (n=33; 19 female; mean age=65 years; mean BMI=33) posterior stabilized knees. Four experienced knee surgeons followed a standardized surgical technique (PCL resection, patella resurfacing, RSA bead placement in polyethylene and tibia) and post-operative protocol (CPM as tolerated, no drains, WBAT). SF-36, WOMAC, PCS, KSCRS were administered to all patients pre-operatively and at 6, 12 and 24 months post-operatively and BMI was recorded. Within 4 days of surgery and at 6, 12 and 24 months post-operatively patients underwent bi-planar x-rays.

Results: The TM group had greater initial migration but appeared stabilized at 1 year. There were 2 significant subgroups in the TM group based on migration at 6 months: one group had mean values of 2.1 mm while the other had mean values of 0.4 mm which was comparable to the modular group (0.6 mm). There was no significant migration between 6 and 12 months for both implants indicating good fixation to the proximal tibia. There were no differences between groups in the outcome measures, age and BMI.

Conclusions: There was no difference in MTPM between groups at 1 year post-op and all knees appeared well fixed to the proximal tibia by 6 months postop. The Nexgen TM monoblock tibial component seemed to be prone to greater initial migration but it does not appear to compromise long-term bony in-growth and fixation. Long-term survivorship of the TM tibial component should be the same or better than a cemented cobalt chrome tray.

Funding : Other Education Grant

Funding Parties : Unrestricted grant from Zimmer Inc.