Abstract
Introduction
The orthopaedic market offers more than two hundred different hip femoral stems. Of these, very few have undergone scientific studies with published results. The differences of designs of the stem are mainly related to surface texture and geometry sections. The development of a new cemented hip prosthesis is certainly a very hard task if aiming the improvement of actual performance.
Materials and Methods
This study presents the influence of geometric variables in a novel hip stem concept which was based on the comparison of the performance of the best cemented stems actually in the market. The study was developed using finite element analysis and experiments with in vitro femoral replacements. A numerical simplified model of the hip replacement was designed to generate the final geometry of the femoral stem section. After an in vitro cemented commercial stem was done, with the best cemented stem a Lubinus, Charnley, Stanmore and Müller. Realistic numerical models also allowed us to determine cement mantle stresses of commercial femoral stems that were compared with those obtained for the new concept stem. The new model was then prototyped and tested through in vitro fatigue tests. Finally fatigue tests were also performed to determine the density of cracks in the cement mantles, as well as debonding for both conventional and new designs.
Results
Stem section geometry influences the fatigue mechanism at the stem–cement interface and is an important factor in the load transfer. The organic section presents 60% (average) less cement stress than sharp sections. Concerning the new stem, detail design geometry parameters were analyzed, such as collar position and orientation, medial radius and geometry of the stem tip. The simulations performed show that the new stem design presents 98.5% of cement volume under an equivalent stress lower than 3 MPa [FIG 1]. The correlation factor between this percentage with the clinical follow up results for 10 years of commercial stems is 0.964, being p=0.641 the significance level of one tailed Person correlation.
Discussion
The variables associated to the stem geometry presents influence in the cement mantle stress and could improve the success. The section of stem is an important factor to improve the load transfer. The [FIG. 2] presents a resume of some variables in a new concept. The inclination of collar 5° at sagital plane reduces the stress in 10% proximally. The tip geometry influences the stress in cement and improves the femoral position. The tip geometry could reduce 20% of cement stress in distal region.
Conclusions
The new femoral design was based on the findings of the finite element analysis and fatigue tests. It presents an innovative collar, “organic” geometry sections and a geometry tip that minimizes stress concentration. The stem developed reduces the cement stresses in an average of 25% relatively to the commercial stems used in the study. The work demonstrates in a new hip concept that small details in design of cemented hip may have consequences in the implant success.
