Total Elbow Arthroplasty (TEA) is recognized as an effective treatment solution for patients with rheumatoid arthritis or for traumatic conditions. Current total elbow devices can be divided into linked or unlinked design. The first design usually presents a linking element (i.e. an axle) to link together the ulnar and humeral components to stabilize the joint; the second one does not present any linkage and the stability is provided by both intrinsic design constraints and the soft tissues. Convertible modular solutions allow for an intraoperative decision to link or unlink the prosthesis; the modular connections introduce however additional risks in terms of both mechanical strength and potential fatigue and fretting phenomena that may arise not only due to low demand activities loads, but also high demand (HD) ones that could be even more detrimental. The aim of this study was to assess the strength of the modular connection between the axle and the ulnar component in a novel convertible elbow prosthesis design under simulated HD and activities of daily living (ADLs) loading. A novel convertible total elbow prosthesis (LimaCorporate, IT) comprising both ulnar and humeral components that can be linked together by means of an axle, was used. Both typical ADLs and HD torques to be applied to the axle were determined based on finite element analysis (FEA); the boundary load conditions for the FEA were determined based on kinematics analysis on real patients in previous studies. The FEA resultant moment acting on the axle junction during typical ADLs (i.e. feeding with 7.2lbs weight in hand) was 3.2Nm while for HD loads (i.e. sit to stand) was 5.7 Nm. In the experimental setup, 5 axle specimens coupled with 5 ulnar bodies through a tapered connection (5 Nm assembly torque) were fixed to a torque actuator (MTS Bionix) and submerged in a saline solution (9g/l). A moment of 3.2 Nm was applied to the axle for 5M cycles through a fixture to test it under ADLs loading. After 5M cycles, the axles were analyzed with regards to fretting behavior and then re-assembled to test them against HD loading by applying 5.7 Nm for 200K cycles (corresponding to 20 years function).Introduction
Methods
The interaction between the mobile components of total elbow replacements (TER) provides additional constraint to the elbow motion. Semi-constrained TER depend on a mechanical linkage to avoid dislocation and have greater constraint than unconstrained TER that rely primarily in soft tissue for joint stability. Greater constraint increases the load transfer to the implant interfaces and the stresses in the polyethylene components. Both of these phenomena are detrimental to the longevity of TER, as they may result in implant loosening and increased damage to the polyethylene components, respectively[1]. The objective of this work was to compare the constraint profile in varus-valgus and internal-external rotation and the polyethylene stresses under loads from a common daily activity between two semi-constrained TER, Coonrad/Morrey (Zimmer-Biomet) and Discovery® (DJO), and an unconstrained TER, TEMA (LimaCorporate). We developed finite element (FE) models of the three TER mechanisms. To reduce computational cost, we did not include the humeral and ulnar stems. Materials were linear-elastic for the metallic components (ETi6Al4V=114.3 GPa, ECoCr=210 GPa, v=0.33) and linear elastic-plastic for the polyethylene components (E=618 MPa, v=0.46; SY=22 MPa; SU=230.6 MPa; εU=1.5 mm/mm). The models were meshed with linear tetrahedral elements of sizes 0.4–0.6 mm. We assumed a friction coefficient of 0.02 between metal and polyethylene. In all simulations, the ulnar component was fixed and the humeral component loaded. We computed the constraint profiles in full extension by simulating each mechanism from 8° varus to 8° valgus and from 8° internal to 8° external rotation. All other degrees-of-freedom except for flexion extension were unconstrained. Then, we identified the instant during feeding that generated the highest moments at the elbow[2], and we applied the joint forces and moments to each TER to evaluate the stresses in the polyethylene. To validate the FE results, we experimentally evaluated the constraint of the design with highest polyethylene stresses in pure internal-external rotation and compared the results against those from a FE model that reproduced the experimental setup (Fig.1-a).Introduction
Methods
