Design and cadaveric validation of a novel device to quantify knee stability during total knee arthroplasty

The success of total knee arthroplasty depends, in part, on the ability of the surgeon to properly manage the soft tissues surrounding the joint, but an objective definition as to what constitutes acceptable postoperative joint stability does not exist. Such a definition may not exist due to lack of suitable instrumentation, as joint stability is currently assessed by visual inspection while the surgeon manipulates the joint. Having the ability to accurately and precisely measure knee stability at the time of surgery represents a key requirement in the process of objectively defining acceptable joint stability. Therefore, we created a novel sterilizable device to allow surgeons to measure varus-valgus, internal-external, or anterior-posterior stability of the knee during a total knee arthroplasty. The device can be quickly adjusted between 0 deg and 90 deg of knee flexion. The device interfaces with a custom surgical navigation system, which records the resultant rotations or translations of the knee while the surgeon applies known loads to a patient's limb with a handle instrumented with a load cell. We validated the performance of the device by having volunteers use it to apply loads to a mechanical linkage that simulated a knee joint; we then compared the joint moments calculated by our stability device against those recorded by a load cell in the simulated knee joint. Validation of the device showed low mean errors (less than 0.21 ± 1.38 Nm and 0.98 ± 3.93 N) and low RMS errors (less than 1.5 Nm and 5 N). Preliminary studies from total knee arthroplasties performed on ten cadaveric specimens also demonstrate the utility of our new device. Eventually, the use of this device may help determine how intra-operative knee stability relates to postoperative function and could lead to an objective definition of knee stability and more efficacious surgical techniques.