Abstract
We introduce a novel active tensioning system that can be used for dynamic gap-based implant planning as well as for assessment of final soft tissue balance during implant trialing. We report on the concept development and preliminary findings observed during early feasibility testing in cadavers with two prototype systems.
System description
The active spacer (fig 1) consists of a motorized actuator unit with integrated force sensors, independently actuated medial and lateral upper arms, and a set of modular attachments for replicating the range of tibial baseplate and insert trial sizes. The spacer can be controlled in either force or position (gap) control and is integrated into the OMNIBoticsTM Robotic-assisted TKA platform (OMNI, MA, USA).
Cadaver Study
Two design iterations were evaluated on eleven cadaver specimens by seven orthopaedic surgeons in three separate cadaver labs. The active spacer was used in a tibial-first technique to apply loads and measure gaps prior to and after femoral resections. To determine the range of forces applied on the spacer during a varus/valgus assessment procedure, each surgeon performed a varus/valgus stress test and peak medial and lateral forces were measured. Surgeons also rated the feel of the stability of the knee at 50N and 80N of preload using the following scale: 1 – too loose; 2 – slightly loose; 3 – ideal; 4 slightly tight; 5 – too tight. Final balanced was assessed with the spacer and with manual trial components.
Results
Overall the prototype system successfully met the functional requirements for applying controlled tension during ligament balancing, and user feedback on usability and feasibility for use in TKA was highly positive.
Peak forces measured during blinded stability assessments were significantly imbalanced from medial to lateral and exhibited a wide range across users (range: 70N – 310N, table 1). Each surgeon rated 50N of tension as feeling “slightly loose” and 80N as feeling “ideal” in extension.
“Ideal” soft tissue balance was achieved in the last three knees tested using the second design iteration, as rated by the surgeons with final trial components in place.
Discussion
Our preliminary cadaver results have established the initial feasibility of the active spacer concept for applying tension during ligament balancing and implant planning.
Our initial results also suggest that performing a varus/valgus assessment without force readings can lead to imbalanced mediolateral load application. This may be due to factors such as hand dominance and pulling in varus versus pushing in valgus. There was also considerable inter-surgeon variability in the peak forces applied. An advantage of computer-controlled ligament tensioning and force sensing is ability to standardize applied mediolateral forces across patients and surgeons.
In the assessment of the ‘ideal' static ligament tension in extension a force of 80N was preferred over 50N, which is in the range of forces applied by others during ligament balancing. What is the ideal patient specific force to apply remains a topic of future research. Our next steps will be to further evaluate use of the system in the context of virtual trialing.
