Soft tissue balancing in knee arthroplasty remains an art. To make it a science reliable quantification and reference values for soft tissue tension and contact loads are necessary. This study intends to prove the concept of a compartmental load safe target zone as a clinical tool for balancing total knee arthroplasties by studying the relationship between post- balancing compartmental load distribution and patient satisfaction at 6 months. In this prospective non-randomised clinical series of 102 patients (110 knees), medial and lateral loads were recorded intra-operatively using a tibial liner load sensor system. All knees were balanced using specific algorithm sequences with a goal of equal distribution between compartments. A safe target zone area was defined on a scatterplot graph displaying lateral versus medial loads. Individual points on the graft were coded with their satisfaction score at 6 months.INTRODUCTION
MATERIALS AND METHODS
Ligament balancing aims to equalize lateral and medial gaps or tensions for optimal functional outcomes. Balancing can now be measured as lateral and medial contact forces during flexion (Roche 2014). Several studies found improved functional outcomes with balancing (Unitt 2008; Gustke 2014a; Gustke 2014b) although another study found only weak correlations (Meneghini 2016). Questions remain on study design, optimal lateral-medial force ratio, and remodeling over time. Our goals were to determine the functional outcomes between pre-op and 6 months post-op, and determine if there was a range of balancing parameters which gave the highest scores. This IRB study involved a single surgeon and the same CR implant (Triathlon). Fifty patients were enrolled age 50–90 years. A navigation system was used for alignments. Balancing aimed for equal lateral and medial contact forces throughout flexion, using various soft tissue releases (Meneghini 2013; Mihalko 2015). The patients completed a Knee Society evaluation pre-op, 4 weeks, 3 months and 6 months. The total (medial+lateral) force, and the medial/(medial+lateral) force ratio was calculated for 4 flexion angles and averaged. These were plotted against Pain, Satisfaction, Delta Function (postop – preop), and Delta Flexion Angle. The data was divided into 2 groups. 1. By balancing parameters. T-Test for differences in outcomes between the 2 groups. 2. By outcome parameters. T-Test for differences in Balancing Parameters between the two groups.INTRODUCTION
METHODS
There are many factors which contribute to function after TKA. In this study we focus on the effect of varus-valgus (VV) balancing measured externally. A loose knee can show instability (Sharkey 2014) while too tight, flexion can be limited. Equal lateral-medial balancing at surgery leads to a better result (Unitt 2008; Gustke 2014), which is generally the surgical goal. Indeed similar varus and valgus laxity angles have been found in most studies in vitro (Markolf 2015; Boguszewski 2015) and in vivo (Schultz 2007; Clarke 2016; Heesterbeek 2008). The angular ranges have been 3–5 degrees at 10–15 Nm of knee moment, females having the higher angles. The goal of this study was to measure the varus and valgus laxity, as well as the functional outcome scores, of two cohorts; well-functioning total knees after at least one year follow-up, and subjects with healthy knees in a similar age group to the TKR's. Our hypothesis was that the results will be equal in the two groups. 50 normal subjects average age 66 (27 male, 23 female) and 50 TKA at 1 year follow-up minimum average age 68 years (16 male, 34 female) were recruited in this IRB study. The TKA's were performed by one surgeon (PAM) of one TKA design, balancing by gap equalization. Subjects completed a KSS evaluation form to determine functional, objective, and satisfaction scores. Varus and valgus measurements were made using the Smart Knee Fixture (Figure 1)(Borukhov 2016) at 20 deg flexion with a moment of 10 Nm.INTRODUCTION
METHODS & MATERIALS
The role of soft tissue balancing in optimizing function and is gaining interest. Consistent soft tissue balancing has been aided by novel technologies that can quantify loads across the joint at the time of surgery. In theory, compressive load equilibrium should be correlated with ligamentous equilibrium between the medial and lateral collateral ligaments. The authors propose to use the Coronal Angular Deviation Ratio (CADR) as a functional tool to quantify and track surgical changes in laxity of the collateral ligaments over time and correlate this ratio to validated functional scores and patient reported outcomes. The study is a prospective IRB approved clinical study with three cohorts: (1) a surgical prospective study group (n=112 knees in101 patients) with balanced compartmental loads (2) a matched control group of non-operated high function patients (n=50); (3) a matched control group of high function knee arthroplasty recipients (n=50). Standard statistical analysis method is applied. The testing is performed using a validated angular deviation measuring device. The output variables for this report consist of the maximum numerical angular change of the knee in the coronal plane at 10 degrees of flexion produced by a controlled torque application of 10 Nm in the varus and valgus (VV) directions. This is reported as a ratio (CADR=Varus deviation / Total deviation). The New Knee Society Score is used to track outcomes.INTRODUCTION
MATERIALS AND METHODS
There are many factors which contribute to function after TKA. In this study we focus on the effect of varus-valgus (VV) balancing measured externally. A loose knee can show instability (Sharkey 2014) while too tight, flexion can be limited. Equal lateral-medial balancing at surgery leads to a better result (Unitt 2008; Gustke 2014), which is generally the surgical goal. Indeed similar varus and valgus laxity angles have been found in most studies in vitro (Markolf 2015; Boguszewski 2015) and in vivo (Schultz 2007; Clarke 2016; Heesterbeek 2008). The angular ranges have been 3–5 degrees at 10–15 Nm of knee moment, females having the higher angles. The goal of this study was to measure the varus and valgus laxity, as well as the functional outcome scores, of two cohorts; well-functioning total knees after at least one year follow-up, and subjects with healthy knees in a similar age group to the TKR's. Our hypothesis was that the results will be equal in the two groups. 50 normal subjects average age 66 (27 male, 23 female) and 50 TKA at 1 year follow-up minimum average age 68 years (16 male, 34 female) were recruited in this IRB study. The TKA's were performed by one surgeon (PAM) of one TKA design, balancing by gap equalization. Subjects completed a KSS evaluation form to determine functional, objective, and satisfaction scores. Varus and valgus measurements were made using the Smart Knee Fixture (Borukhov 2016) at 20 deg flexion with a moment of 10 Nm. The statistical results demonstrated that there was no significant difference in either varus or valgus laxity between the two groups ( The hypothesis of equal varus and valgus angles in the 2 groups was supported. The larger varus angle implied a less stiff lateral collateral compared with the medial collateral. If the TKA's were balanced equally at surgery, it is possible there was ligament remodeling over time. However the functional scores were inferior for the TKA compared with normal. This finding has not been highlighted in the literature so far. The causes could include weak musculature (Yoshida 2013), non-physiologic kinematics due to the TKA design, or the use of rigid materials in the TKA. The result presents a challenge to improve outcomes after TKA.