Abstract
Introduction
Cementless total knee arthroplasty (TKA) designs are clinically successful and allow for long term biological fixation. Utilizing morselized bone to promote biological fixation is a strategy in cementless implantation. However, it is unknown how bone debris influences the initial placement of the tray. Recent findings show that unseated tibia trays without good contact with the tibial resection experience increased motion. This current study focuses on the effect of technique and instrument design on the initial implantation of a cementless porous tibia. Specifically, can technique or instrument design influence generation of bone debris, and thereby change the forces required to fully seat a cementless tray with pegs?
Methods
This bench top test measured the force-displacement curve during controlled insertion of a modern cementless tibia plate with two fixation pegs. A total of nine pairs of stripped human cadaver tibias were prepared according to the surgical technique. However, the holes for the fixation pegs were drilled intentionally shallow to isolate changes in insertion force due to the hole preparation. A first generation instrument set (Instrument 1.0) and new instrument set design (Instrument 2.0), including a new drill bit designed to remove debris from the peg hole, were used. The tibias prepared with Instrument 1.0 were either cleaned to remove bone debris from the holes or not cleaned. The tibias prepared with the Instrument 2.0 instruments were not cleaned, resulting in three groups: Instrument 1.0 (n=7), Instrument 1.0 Cleaned (n=5), and Instrument 2.0 (n=6). Following tibia resection and preparation of holes for the fixation pegs, the tibias were cut and potted in bone cement ensuring the osteotomy was horizontal. The tibial tray was mounted in a load frame (Enduratec) and the trays were inserted at a constant rate (0.169mm/sec) while recording the force. The test was concluded when the pegs were clearly past the bottom of the intentionally shallow holes.
Results
The force-displacement curves from this method were dependent on the instrument used and cleaning of the holes. Instrument 2.0 specimens were inserted about 2 mm past the maximum peg depth before experiencing a significant increased resistance. The Instrument 1.0 Cleaned holes saw an increase in force slightly past the maximum peg depth, while the Instrument 1.0 group saw increase in force around 1 mm before reaching the maximum peg depth. The average insertion force required to reach maximum peg depth was significantly higher (p<0.05) for the Instrument 1.0 group (790.7 N, sd=185.9) than both the Instrument 1.0 Cleaned (429.7 N, sd=116.8) and the Instrument 2.0 group (580.4 N, sd=89.3). The insertion forces at a ‘mid-tunnel’ location, before the increase in resistance, were not affected by drill design as the drill diameters were the same, resulting in the same press fit.
Conclusions
Bone debris in fixation feature holes increases the force to fully seat a cementless tibia plate. This suggests there is a cost to leaving morselized bone in place. Removing bone debris through instrument design or surgical technique can ensure that a tibial plate is fully seated at time of implantation, maximizing initial fixation.
