A.C.T. Vrancken

Short Term Evaluation of an Anatomically Shaped Polycarbonate Urethane Total Meniscus Replacement in a Goat Model

Purpose Since the treatment options for symptomatic total meniscectomy patients are still limited, an anatomically shaped, polycarbonate urethane (PCU), total meniscus replacement was developed. This study evaluates the in vivo performance of the implant in a goat model, with a specific focus on the implant location in the joint, geometrical integrity of the implant and the effect of the implant on synovial membrane and articular cartilage histopathological condition. Methods The right medial meniscus of seven Saanen goats was replaced by the implant. Sham surgery (transection of the MCL, arthrotomy and MCL suturing) was performed in six animals. The contralateral knee joints of both groups served as control groups. After three months follow-up the following aspects of implant performance were evaluated: implant position, implant deformation and the histopathological condition of the synovium and cartilage. Results Implant geometry was well maintained during the three month implantation period. No signs of PCU wear were found and the implant did not induce an inflammatory response in the knee joint. In all animals, implant fixation was compromised due to suture breakage, wear or elongation, likely causing the increase in extrusion observed in the implant group. Both the femoral cartilage and tibial cartilage in direct contact with the implant showed increased damage compared to the sham and sham-control groups. Conclusion This study demonstrates that the novel, anatomically shaped PCU total meniscal replacement is biocompatible and resistant to three months of physiological loading. Failure of the fixation sutures may have increased implant mobility, which probably induced implant extrusion and potentially stimulated cartilage degeneration. Evidently, redesigning the fixation method is necessary. Future animal studies should evaluate the improved fixation method and compare implant performance to current treatment standards, such as allografts.

The sensitivity of cartilage contact pressures in the knee joint to the size and shape of an anatomically shaped meniscal implant

Since meniscal geometry affects the cartilage contact pressures, it is essential to carefully define the geometry of the synthetic meniscal implant that we developed. Recently, six independent modes of size- and shape-related geometry variation were identified through 3D statistical shape modeling (SSM) of the medial meniscus. However, this model did not provide information on the functional importance of these geometry characteristics. Therefore, in this study finite element simulations were performed to determine the influence of anatomically-based meniscal implant size and shape variations on knee cartilage contact pressures. Finite element simulations of the knee joint were performed for a total medial meniscectomy, an allograft, the average implant geometry, six implant sizes and ten shape variations. The geometries of the allograft and all implant variations were based on the meniscus SSM. Cartilage contact pressures and implant tensile strains were evaluated in full extension under 1200N of axial compression. The average implant induced cartilage peak pressures intermediate between the allograft and meniscectomy and also reduced the cartilage area subjected to pressures >5MPa compared to the meniscectomy. The smaller implant sizes resulted in lower cartilage peak pressures and compressive strains than the allograft, yet high implant tensile strains were observed. Shape modes 2, 3 and 6 affected the cartilage contact stresses but to a lesser extent than the size variations. Shape modes 4 and 5 did not result in changes of the cartilage stress levels. The present study indicates that cartilage contact mechanics are more sensitive to implant size than to implant shape. Down-sizing the implant resulted in more favorable contact mechanics, but caused excessive material strains. Further evaluations are necessary to balance cartilage contact pressures and material strains to ensure cartilage protection and longevity of the implant.

3D geometry analysis of the medial meniscus – a statistical shape modeling approach

The geometry‐dependent functioning of the meniscus indicates that detailed knowledge on 3D meniscus geometry and its inter‐subject variation is essential to design well functioning anatomically shaped meniscus replacements. Therefore, the aim of this study was to quantify 3D meniscus geometry and to determine whether variation in medial meniscus geometry is size‐ or shape‐driven. Also we performed a cluster analysis to identify distinct morphological groups of medial menisci and assessed whether meniscal geometry is gender‐dependent. A statistical shape model was created, containing the meniscus geometries of 35 subjects (20 females, 15 males) that were obtained from MR images. A principal component analysis was performed to determine the most important modes of geometry variation and the characteristic changes per principal component were evaluated. Each meniscus from the original dataset was then reconstructed as a linear combination of principal components. This allowed the comparison of male and female menisci, and a cluster analysis to determine distinct morphological meniscus groups. Of the variation in medial meniscus geometry, 53.8% was found to be due to primarily size‐related differences and 29.6% due to shape differences. Shape changes were most prominent in the cross‐sectional plane, rather than in the transverse plane. Significant differences between male and female menisci were only found for principal component 1, which predominantly reflected size differences. The cluster analysis resulted in four clusters, yet these clusters represented two statistically different meniscal shapes, as differences between cluster 1, 2 and 4 were only present for principal component 1. This study illustrates that differences in meniscal geometry cannot be explained by scaling only, but that different meniscal shapes can be distinguished. Functional analysis, e.g. through finite element modeling, is required to assess whether these distinct shapes actually influence the biomechanical performance of the meniscus.

Functional biomechanical performance of a novel anatomically shaped polycarbonate urethane total meniscus replacement

PurposeTo evaluate the functional biomechanical performance of a novel anatomically shaped, polycarbonate urethane total meniscus implant.MethodsFive human cadaveric knees were flexed between 0° and 90° under compressive loads mimicking a squat movement. Anteroposterior (AP) laxity tests were performed in 30° and 90° flexion. Meniscal kinematics and knee laxity were quantified using roentgen stereophotogrammetric analysis. Tibial cartilage contact mechanics were determined in 90° flexion. Measurements were repeated for the native medial meniscus, the implant, after total medial meniscectomy and allograft transplantation.ResultsThe implant and allograft displayed increased posterior and medial displacements compared to the native meniscus, yet no differences were found between the implant and allograft. Meniscal condition did not affect rotational laxity. Compared to the native joint, AP laxity for the implant was increased in 30° flexion, but not in 90°. The implant reduced the mean contact pressure compared to meniscectomy but could not restore contact pressures to native meniscus levels. Compared to the native meniscus, the implant significantly increased the peak pressure, while the contact area was reduced. Contact mechanics of the implant and allograft were never statistically different.ConclusionsBiomechanical performance was similar for the implant and allograft. However, both meniscal replacements could not restore outcomes to native meniscus levels or sufficiently improve outcomes after meniscectomy. This was presumably caused by the mobility allowed by the suture-only horn fixation. The similarity of implant and allograft performance suggests that the novel implant has the biomechanical potential to serve as an alternative to meniscal allograft transplantation.

In Vivo Performance of a Novel, Anatomically Shaped, Total Meniscal Prosthesis Made of Polycarbonate Urethane: A 12-Month Evaluation in Goats

Background: Injury or loss of the meniscus generally leads to degenerative osteoarthritic changes in the knee joint. However, the treatment options for symptomatic patients with total meniscectomy are limited. Therefore, we developed a novel, anatomically shaped, total meniscal implant made of polycarbonate urethane. Purpose: To evaluate the in vivo performance of this novel total meniscal implant. The assessment particularly focused on the implant’s response to long-term physiological loading in a goat model and its chondroprotective capacity in comparison to clinically relevant controls. Study Design: Controlled laboratory study. Methods: Surgery was performed to the stifle joint of 26 female Saanen goats, subdivided into 4 groups: implant, allograft, total meniscectomy, and sham surgery. The sham group’s contralateral joints served as nonoperated controls. After 12 months of follow-up, investigators evaluated implant wear, deformation, and the histopathological condition of the synovium and cartilage. Results: Wear of the implant’s articulating surfaces was minimal, which was confirmed by the absence of wear particles in the synovial fluid. Implant deformation was limited. However, one implant failed by complete tearing of the posterior horn extension. No differences in cartilage histopathological condition were observed for the implant, allograft, and meniscectomy groups. However, locally, the cartilage scores for these groups were significantly worse than those of the nonoperated controls. Conclusion: Whereas this study demonstrated that the novel implant is resistant to wear and that deformation after 12 months of physiological loading is acceptable, reinforcement of the implant horns is necessary to prevent horn failure. Although the implant could not protect the cartilage from developing degenerative changes, the progression of damage was similar in the allograft group. Clinical Relevance: This novel polycarbonate urethane implant may have the potential to become an alternative treatment for symptomatic patients with total meniscectomy.

Releasing the circumferential fixation of the medial meniscus does not affect its kinematics

BACKGROUND Meniscal functioning depends on the fixation between the meniscal horns and the surrounding tissues. It is unknown, however, whether the integration between the outer circumference of the medial meniscus and the knee capsule/medial collateral ligament also influences the biomechanical behavior of the meniscus. Therefore, we aimed to determine whether detaching and resuturing the circumferential fixation of the medial meniscus influence its kinematic pattern. METHODS Human cadaveric knee joints were flexed (0°-30°-60°-90°) in a knee loading rig, in neutral orientation and under internal and external tibial torques. Roentgen stereophotogrammetric analysis was used to determine the motion of the meniscus in anteroposterior (AP) and mediolateral (ML) directions. Three fixation conditions were evaluated: (I) intact, (II) detached and (III) resutured. RESULTS Detaching and resuturing the circumferential fixation did not alter the meniscal motion pattern in either the AP or ML direction. Applying an additional internal tibial torque caused the medial meniscus to move slightly anteriorly, and an external torque caused a little posterior translation with respect to the neutral situation. These patterns did not change when the circumferential fixation condition was altered. CONCLUSIONS This study demonstrated that the motion pattern of the medial meniscus is independent of its fixation to the knee capsule and medial collateral ligament. CLINICAL RELEVANCE The outcomes of this study can be deployed to design the fixation strategy of a permanent meniscus prosthesis. As peripheral fixation is a complicated step during meniscal replacement, the surgical procedure is considerably simplified when non-resorbable implants do not require circumferential fixation.