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
The first carpometacarpal (CMC) joint is the second most common joint of the hand affected by degenerative osteoarthritis (OA)1. Laxity of ligamentous stabilizers that attach the first metacarpal bone (MC1) and the trapezium bone (TZ), notably the volar anterior oblique ligament (AOL), has been associated with cartilage wear, joint space narrowing, osteophyte formation, and dorsal-radial CMC subluxation2. In addition, the proximal-volar end of the MC1 has a bony prominence known as the palmar lip (PL) that adds conformity to this double-saddle joint, and is thought to be a supplemental dorsal stabilizer. Currently, no study has looked at the changes to the 3D shape and relative positions of these structures with OA. CT scans of patients with clinically diagnosed CMC OA (n=11, mean age 73 [60–97], 8 females) and CT scans of ‘normal’ patients with no documented history of CMC OA (n=11, mean age 37 [20–51], 6 females) were obtained with the hand in a prone position. 3D reconstructions of the MC1 and TZ bones were created, and each assigned a coordinate system3. The long axis of the MC1 and the proximal-distal axis of the TZ were established, and the location where they intersected the CMC articular surface was defined as their articular center points, X and O, respectively (Figure 1). Using the TZ as a fixed reference, we calculated the relative position of X in the dorsal-ventral and radial-ulnar directions. A two sample t-test was performed to compare the normal and OA groups. In addition, the distal position of the PL relative to X was recorded.Introduction
Methods
Implant designs for hip and knee arthroplasty have undergone a continual improvement process, but development of implants for total elbow arthroplasty (TEA) have lagged behind despite the marked mechanical burden placed on these implants. TEA is not as durable with failure rates approaching thirty percent at five years. The Coonrad-Morrey (Zimmer, Warsaw, IN), a linked design, remains the standard-bearer, employing polyethylene bushings through which a metal axle passes. A common failure mode is bushing wear and deformation, causing decreased joint function as the bushing-axle constraint decreases and osteolysis secondary to release of large volumes of wear debris. Improving upon this poor performance requires determining which factors most influence failure, so that failure can be avoided through design improvements. The approach integrates clinical observations of failed TEAs with implant retrieval analysis, followed by measurements of loads across the elbow for use in stress analyses to assess the performance of previous designs, and, finally, new design approaches to improve performance. Examination of the clinical failures of more than seventy Coonrad-Morrey TEAs revealed patterns of decreased constraint and stem loosening. Implant retrieval analysis from more than thirty of these cases showed excessive bushing deformation and wear and burnishing of the fixation stems consistent with varus moments across the joint. To determine loads across the elbow, motion analysis data were collected from eight TEA patients performing various activities of daily living. The kinematic data were input into a computational model to calculate contact forces on the total elbow replacement. The motion that produced the maximum contact force was a feeding motion with the humerus in 90° of abduction. For this motion, the joint reaction forces and moments at the point of maximum contact were determined from a computational model. We applied these loads to numerical models of the articulating bushings and axle of the Coonrad-Morrey to examine polyethylene strains as measures of damage and wear. Strain patterns in response to the large varus moment applied to the elbow during feeding activities showed extensive plastic deformation in the locations at which deformation and wear damage were observed in our retrieved implants (Fig. 1). Finally, we examined a new semi-constrained design concept intended to meet two goals: transfer contact loads away from the center of the joint, thus allowing contact to provide a larger internal moment to resist the large external varus moment; and reduce polyethylene strains by utilizing curved contacting surfaces on both the axle and the bushings (Fig. 2). After a sensitivity analysis to determine optimal dimensional choices (e.g., bushing and axle radii), we compared the resulting polyethylene strains between the Coonrad-Morrey and new design at locations that experienced the largest strains (Fig. 3). Substantial decreases were achieved, suggesting far less deformation and wear, which should relate to marked improvements in performance. Currently, we are incorporating this new design concept, along with alterations in stem design achieved from examination of load transfer at the fixation interfaces based on the same loading conditions, to achieve an implant system intended to improve the performance of TEA.
