Patient-reported satisfaction is a critical measure in understanding the clinical success of total knee arthroplasty. Yet, satisfaction levels in TKA patients are generally lower than THA patients; and surgeon-patient agreeability regarding clinical success is typically in discordance. Thus, the purpose of this evaluation was to report on the one-year satisfaction data of a group of sensor-assisted TKA patients, and compare that data to the average satisfaction reported in literature, as measured by a meta-analysis. One hundred and thirty five patients received TKA utilizing intra-operative sensing technology to evaluate soft-tissue balance as part of a prospective multicenter study. Patients were classified by two groups: “balanced” and “unbalanced”. Quantitative “balance” was defined as a mediolateral intercompartmental loading difference of ≤ 15 pounds; all loading exceeding 15 pounds was classified as “unbalanced”. At the one-year follow-up visit, a 7-question patient satisfaction survey was administered. The answering schema of this survey was modeled using a modified five-point Likert scale, ranging from “True” to “False” (or “Very Satisfied” to “Very Dissatisfied,” where appropriate). A meta-analysis of literature was performed and studies selected for inclusion in this analysis were required to meet the following criteria: all patients were in receipt of a primary TKA; satisfaction data was collected post-operatively; and the proportion of patients who were “satisfied” to “very satisfied” was statistically described.INTRODUCTION
METHODS
The cost associated with the TKA revision burden is projected to reach 13 billion dollars, annually. Complications reported by post-TKA patients include: pain (44%, multilocational), sensation of instability (21% reason for revision), and joint stiffness (17% reason for revision); problems that may be attributed to soft-tissue imbalance. One of the possible reasons for the substantial prevalence of such complications is the subjectivity associated with defining soft-tissue balance. A priority must be placed on developing new objective methods with which to avoid costly post-operative complications, including the integration of intraoperative sensing technology. The purpose of this evaluation was to report on the disparity between the patient-reported outcomes scores of quantitatively balanced versus unbalanced patients, at 1-year, using a group of 135 multicenter patients. 135 prospective patients, from 8 U.S. sites, have had primary TKA performed with the use of intraoperative sensors. Patients were classified by two groups: “balanced” and “unbalanced”. Quantitative “balance” was defined as a mediolateral intercompartmental loading difference of ≤ 15 pounds; all loading exceeding 15 pounds was classified as “unbalanced”. For all patients, the following kinematic data was captured: varus/valgus stability, anteroposterior stability, flexion contracture (if any), extension lag (if any), anatomic alignment, and ROM. Also at each clinical follow-up visit, activity levels and two patient-reported outcomes measures were administered, including: the American Knee Society Score (KSS), and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).INTRODUCTION
METHODS
During primary total knee arthroplasty, the surgeon may encounter excessive medial collateral ligament tension while addressing a varus knee. This may be due to medial ligament/capsular complex contractures, and/or, due to the creation of a 0 degree mechanical axis in a varus knee. This tension leads to increased loading in the medial compartment, which contributes to an unbalanced extension and flexion gap. If uncorrected, this imbalance can lead to unfavorable clinical outcomes, including: pain, accelerated polyethylene degradation, joint instability, and limited ROM. Currently, intercompartmental soft-tissue balance is obtained by a subjective surgeon's “feel”. However, this method of judging soft-tissue tension is both variable and unreliable. Most surgeons can detect gross instability, but judging ligament tension is difficult. The following technique describes the integration of intraoperative microelectronic tibial inserts to assess and modify ligament tension, utilizing real-time dynamic sensor feedback 500 TKAs were performed between September 2012 and April 2013, by three collaborating surgeons. All surgeons used the same implant system, compatible with an embedded microelectronic tibial insert with which to receive real-time feedback of femoral contact points and joint kinetics. Intraoperative kinematic data, displayed loading patterns consistent with identifiable intercompartmental imbalance through a full ROM. All mediolateral imbalance, secondary to an excessively tight medial compartment, was addressed with the technique described herein.Introduction
Methods
Flexion instability of the knee accounts for, up to, 22% of reported revisions following TKA. It can present in the early post-operative phase or present— secondary to a rupture of the PCL— in the late post-operative phase. While most reports of instability occur in conjunction with cruciate retaining implants, instability in a posterior-stabilized knee is not uncommon. Due to the prevalence of revision due to instability, the purpose of constructing the following techniques is to utilize intraoperative sensors to quantify flexion gap stability. 500 posterior cruciate-retaining TKAs were performed between September 2012 and April 2013, by four collaborating surgeons. All surgeons used the same implant system, compatible with a microelectronic tibial insert with which to receive real-time feedback of femoral contact points and joint kinetics. Intraoperative kinematic data, as reported on-screen by the VERASENSE™ knee application, displayed similar loading patterns consistent with identifiable sagittal plane abnormalities. These abnormalities were classified as: “Balanced Flexion Gap,” “Flexion Instability” and “Tight Flexion Gap.” All abnormalities were addressed with the techniques described herein.Introduction
Methods
Proper soft-tissue balance is important for achieving favorable clinical outcomes following TKA, as ligament imbalance can lead to pain, stiffness or instability, accelerated polyethylene wear, and premature failure of implants. Until recently, soft-tissue balancing was accomplished by subjective surgeon feel and by use of static spacer blocks. Now, nanonsensor-embedded implant trials allow surgeons to quantify peak load and center of load in the medial and lateral compartments during the procedure, and to adjust ligament tension and implant positioning accordingly. The purpose of this 3-year, multicenter study is to evaluate 500 patients who have received primary TKA with the use of intraoperative sensors in order to correlate quantified ligament balance to clinical outcomes. To date, 7 centers have contributed 215 patients who have undergone primary TKA with the use of intraoperative sensors. Patients are seen at a pre-operative visit (within 3 months prior to surgery), and post-operatively at 6 weeks, 6 months, and at 1, 2, and 3-year anniversaries. Standard demographic and surgical data is collected for each patient, including: age at time of surgery, BMI, operative side, gender, race, and primary diagnosis. At each interval, anatomic alignment and range of motion are assessed; KSS and WOMAC evaluations are administered; and a set of standard radiographs is collected, including: standing anteroposterior, standing-lateral, and the sunrise patellar view. Intraoperative loads were recorded for pre- and post-release joint states. All soft-tissue release techniques were recorded. “Optimal” soft-tissue balance was defined as a medial-lateral load difference of less than or equal to 15 lbs.Introduction
Methods
