Abstract
Introduction
Soft tissue balancing in total knee arthroplasty surgery may prove necessary to elevate patient satisfaction and functional outcome beyond the current fair average. A new generation of contact load sensors embedded in trial tibial liners provides quantification of loads, direction, and an indirect assessment of ligamentous tension. With this technology, quantified intra-operative balancing may potentially restore compartmental load distribution to a more physiological and functional degree.
Objective
1). To define a clinically useful target zone for balancing of the soft tissue envelope of knees at the time of surgery using numerical data from load sensors in tibial liner trial components. 2). To validate the boundaries of the target zone on a medial v. lateral contact load scatterplot with PROMs
Method
This study is a prospective IRB approved clinical study of 104 patients (112 knees) from a single surgeon. The intra-operative balancing aim was the restoration of a physiological compartmental load distribution, defined as less than 15 pounds of load differential between the medial and lateral compartments throughout flexion. This was performed using an algorithmic method of soft tissue releases combined with minor joint line obliquity adjustments within 3 degrees of neutral. Medial v. lateral contact load data was produced at 10, 45, 90° flexion as part of the balancing and final verification process. For all cases the pre and post-operative (4weeks, 3months, 6months) varus and valgus soft tissue envelope was measured with a calibrated and validated knee fixture. The KSS scores were obtained at each measurement interval.
Results
The majority of knees were successfully balanced within a cluster zone as shown in Fig. 1. The concept of a safe target zone was developed to define a safe zone of balancing with higher predictive value for satisfaction and function. This was created using a best-fit rhomboid area, whose perimeter uses the fusion of a square area defined by min / max absolute loads and a triangular area defined by relative compartmental load ratios (Compartmental Load Ratio=Med Load/Total Load). The best-fit load boundaries to optimize patient satisfaction are 12.5 lbs.-38 lbs. (static load) and 44%–59% (relative load distribution) (Fig.2). Using these boundaries 83% of the cases in the safe zone area scored above 80% on the satisfaction score at 6 months compared to 36% for those outside the rhomboid area (Fig. 3).
Conclusions
Balancing by load distribution uses a combination of distinct single surgical variable corrections of soft tissue releases and minor bone adjustments. Using a systematic balancing algorithm, the medial and lateral compartmental loads can predictably be balanced within a defined target zone, delineated by absolute load values and by relative compartmental load ratios. Based on this series the method is proving reproducible. The accuracy obtained by matching patient satisfaction values appears to validate the potential of a target zone as a safe and predictable clinical tool for balancing.
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