Abstract
The design of every post-surgical knee arthroplasty study begins with the question “How soon after surgery should we assess the patients?”. The consensus, based primarily upon clinical rating systems, is that patients' scores reach a plateau roughly one year after surgery, and that observations performed at that time should be indicative of the long-term behavior of the joint. This is satisfactory for long-term studies of clinical performance. However, when new devices are introduced there is a need to determine as quickly as possible if the device performs as designed. Waiting a year or more after surgery to characterize a device's performance may place additional patients at risk of receiving an inferior design, or may delay widespread availability of a superior design. The goal of this study was to assess knee arthroplasty patients at 6–12 weeks, 6 months and 1 year after surgery to determine if their tibiofemoral kinematics changed during functional activities.
A total of 13 patients (7 female) were recruited from an ongoing clinical study to participate in this IRB-approved sub-study. All subjects received fixed-bearing, cemented, posterior-cruciate-retaining total knee arthroplasty of the same design from a single surgeon. Subjects averaged 69 years, 169cm tall, and 28 BMI. Subjects were studied at 6–12 weeks, at 6 months and at 12 months post-surgery, when they showed an average clinical flexion of 106°, 113° and 115°, respectively. Subjects' knees were observed using pulsed-flat-panel-fluoroscopy during three activities: lunging to maximum flexion with their foot placed on a 20cm step, kneeling to maximum flexion on a padded bench, and step-up/down on a 20cm step without progression of the contralateral limb. Model-image registration was used to register 3D geometric models of the implants with their radiographic projections based upon measured projection parameters. 3D knee kinematics were derived from the registered models, including joint angles and the antero-posterior translation of the medial and lateral condyles relative to the tibial baseplate.
There were no statistically significant changes in knee kinematics between the 6–12 week and 6 month, and 6-month and 12-month visits during the kneel and lunge activities (Table 1). Similarly, there were no pair-wise differences in tibial rotation or condylar translation during the dynamic step activity at any flexion angle (Figure 1).
Traditional thinking suggests studies of knee mechanics should be performed at least one year after surgery to make observations that are predictive of long-term joint function. In three different functional activities, we could not demonstrate significant changes in knee kinematics between 6–12 weeks and 6 months, nor between 6 months and 12 months. If these results can be confirmed in a larger subject cohort, and for a range of TKA designs, then functional follow-up studies of novel knee arthroplasty designs might be justified as early as 6–12 weeks after surgery, making it possible to accelerate confirmation devices are performing in patients as designed.
For any figures or tables, please contact the authors directly.
