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Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_11 | Pages 3 - 3
1 Dec 2020
Grupp TM Schilling C Fritz B Reyna ALP Pfaff A Taunt C Mihalko WM
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Introduction

Beneath infection, instability and malalignment, aseptic tibial component loosening remains a major cause of failure in total knee arthroplasty (TKA) [1]. This emphasizes the need for stable primary and long-term secondary fixation of tibial baseplates. To evaluate the primary stability of cemented tibial baseplates, different pre-clinical test methods have been undergone: finite element analysis [2], static push-out [3,4] or dynamic compression-shear loading [5] until interface failure. However, these test conditions do not reflect the long-term endurance under in vivo loading modes, where the tibial baseplate is predominantly subjected to compression and shear forces in a cyclic profile [5,6].

To distinguish between design parameters the aim of our study was to develop suitable pre-clinical test methods to evaluate the endurance of the implant-cement-bone interface fixation for tibial baseplates under severe anterior (method I) and internal-external torsional (method II) shear test conditions.

Materials & Methods

To create a clinically relevant cement penetration pattern a 4th generation composite bone model was customised with a cancellous core (12.5 PCF cellular rigid PU foam) to enable for high cycle endurance testing. VEGA System® PS & Columbus® CRA/PSA ZrN-multilayer coated tibial baseplates (2×12) were implanted in the customised bone model using Palacos® R HV bone cement (Figure 1).

An anterior compression-shear test (method II) was conducted at 2500 N for 10 million cycles and continued at 3000 N & 3500 N for each 1 million cycles (total: 12 million cycles) simulating post-cam engagement at 45° flexion. An internal-external torsional shear test (method II) was executed in an exaggeration of clinically relevant rotations [7,8] with ±17.2° for 1 million cycles at 3000 N tibio-femoral load in extension. After endurance testing either under anterior shear or internal-external torsion each tibial baseplate was mounted into a testing frame and maximum push-out strength was determined [3].


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_1 | Pages 4 - 4
1 Feb 2020
Oni J Yi P Wei J Kim T Sair H Fritz J Hager G
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Introduction

Automated identification of arthroplasty implants could aid in pre-operative planning and is a task which could be facilitated through artificial intelligence (AI) and deep learning. The purpose of this study was to develop and test the performance of a deep learning system (DLS) for automated identification and classification of knee arthroplasty (KA) on radiographs.

Methods

We collected 237 AP knee radiographs with equal proportions of native knees, total KA (TKA), and unicompartmental KA (UKA), as well as 274 radiographs with equal proportions of Smith & Nephew Journey and Zimmer NexGen TKAs. Data augmentation was used to increase the number of images available for DLS development. These images were used to train, validate, and test deep convolutional neural networks (DCNN) to 1) detect the presence of TKA; 2) differentiate between TKA and UKA; and 3) differentiate between the 2 TKA models. Receiver operating characteristic (ROC) curves were generated with area under the curve (AUC) calculated to assess test performance.


Orthopaedic Proceedings
Vol. 100-B, Issue SUPP_3 | Pages 48 - 48
1 Apr 2018
Reyna ALP Fritz B Schwiesau J Summer B Thomas P Grupp TM
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Total knee arthroplasty is a well established treatment for degenerative joint disease with good clinical results. However, complications may occur due to a biological response to polyethylene wear particles, leading to osteolysis and aseptic loosening, as well as local and systemic hypersensitivity reactions triggered by metal ions and particles such as chromium, cobalt and molybdenum. Moreover, there is an increasing demand on the performance of these implants, as this treatment is also performed in heavier, younger and middle-aged adults who have a significant physical activity and higher life expectancy. The purpose of the following study was to compare the wear characteristics and performance of a zirconium nitride (ZrN) coated knee implant, designed for patients with metal ion hypersensitivity, against the clinically established cobalt-chromium (CoCr) version under a high demanding activities wear simulation.

Medium size AS Columbus® DD (Aesculap AG, Tuttlingen, Germany) femoral and tibial components with a ZrN surface were tested in comparison with the cobalt-chromium version Columbus® DD. For both groups, ultra-high-molecular weight polyethylene (UHMWPE) gliding surfaces (size T3, high 10 mm) were used. Wear simulation was performed on a load controlled 4 station knee wear simulator (EndoLab GmbH, Thansau, Germany) capable of reproducing loads and movement of daily activities measured in vivo (Bergmann et al, 2014) on 8 patients and normalized to a patient weight of 100 kg (Schwiesau et al, 2014). The load profiles were applied for 5 million cycles in a combination of 40% stairs up, 40% stairs down, 10% level walking, 8% chair raising and 2% deep squatting. Test serum was changed every 0.5 million cycles and all the components were cleaned and analyzed according to ISO 14243-2:2009(E). The gliding surfaces were evaluated for gravimetric wear and wear patterns, femur components analyzed for scratches and the test medium analyzed for metal ion concentration (cobalt, chromium, molybdenum and zirconium) using ICP-MS according to ISO 17294-2.

The present study showed a wear rate reduction for the ZrN group (1.01 ± 0.29 mg/million) in comparison with the CoCr group (2.40 ± 1.18 mg/million cycles). The articulation surface of the ZrN coated femurs remained polished after the testing period, whereas the uncoated femurs showed wear scratches. Furthermore, the metal ion release from the ZrN coated implants was reduced orders of magnitude in comparison with the CoCr implants through the entire test. These results demonstrate the efficiency of ZrN coated knee implants to reduce wear as well as to prevent metal ion release in the knee joint.


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_8 | Pages 11 - 11
1 Apr 2017
Grupp T Fritz B Kutzner I Bergmann G Schwiesau J
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Background

Wear simulation in total knee arthroplasty (TKA) is currently based on the most frequent activity – level walking. A decade ago multi-station knee wear simulators were introduced leading to optimisations of TKA designs, component surface finish and bearing materials. One major limitation is that current wear testing is mainly focused on abrasive-adhesive wear and in vitro testing does not reflect “delamination” as an essential clinical failure mode. The objective of our study was to use a highly demanding daily activities wear simulation to evaluate the delamination risk of polyethylene materials with and without vitamin E stabilisation.

Methods

A cruciate retaining fixed bearing TKA design (Columbus CR) with artificially aged polyethylene knee bearings (irradiation 30±2 kGy) blended with and without 0.1% vitamin E was used under medio-lateral load distribution and soft tissue restrain simulation. Daily patient activities with high flexion (2×40% stairs up and down, 10% level walking, 8% chair raising, 2% deep squatting) were applied for 5 million cycles. The specimens were evaluated for gravimetric wear and analysed for abrasive-adhesive and delamination wear modes.


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_8 | Pages 10 - 10
1 May 2016
Grupp T Fritz B Kutzner I Bergmann G Schwiesau J
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INTRODUCTION

Highly cross-linked polyethylene (XLPE) inserts have shown significant improvements in decreasing wear and osteolysis in total hip arthroplasty [1]. In contrast to that, XLPE has not shown to reduce wear or aseptic loosening in total knee arthroplasty [2,3,4].

One major limitation is that current wear testing in vitro is mainly focused on abrasive-adhesive wear due to level walking test conditions and does not reflect “delamination” as an essential clinical failure mode [5,6].

The objective of our study was to use a highly demanding daily activities wear simulation to evaluate the delamination risk of polyethylene materials with and without vitamin E stabilisation.

MATERIALS & METHODS

A cruciate retaining fixed bearing TKA design (Columbus® CR) with artificially aged polyethylene knee bearings (irradiation 30 & 50 kGy) blended with and without 0.1% vitamin E was used under medio-lateral load distribution and soft tissue restrain simulation. Daily patient activities measured by Bergmann et al. [7] in vivo, were applied for 5 million knee wear cycles in a combination of 40% stairs up, 40 % stairs down, 10% level walking, 8% chair raising and 2% deep squatting with up to 100° flexion [8] (Fig. 1).

The specimens were evaluated for gravimetric wear and analysed for abrasive-adhesive and delamination wear modes.


Orthopaedic Proceedings
Vol. 96-B, Issue SUPP_11 | Pages 223 - 223
1 Jul 2014
Grupp T Kabir K Fritz B Schwiesau J Bloemer W Jansson V
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Summary Statement

To evaluate carbon-fiber-reinforced PEEK as alternative biomaterial for total disc arthroplasty a closed loop between biotribology (in vitro), application of sterile particle suspensions in the epidural space of rabbits and biological response in vivo was established.

Introduction

To prevent adjacent level degeneration in the cervical spine, total disc arthroplasty (TDA-C) remains an interesting surgical procedure for degenerative disc disease. Short- or midterm complications are migration, impaired post-operative neurological assessment due to artefacts in x-ray and MRI diagnosis and substantial rates of heterotopic ossification. The idea was to create a TDA-C design based on a polymer-on-polymer articulation to overcome these limitations of the clinically established metal-on-polyethylene designs. The objective of our study was to characterise the biotribological behaviour of an experimental cervical disc replacement made out of carbon-fiber-reinforced (CFR) PEEK and evaluate the biological response of particulate wear debris in the epidural space in vivo.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXVII | Pages 84 - 84
1 Sep 2012
Schröder C Utzschneider S Grupp T Fritz B Jansson V
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Introduction

Minimally invasive implanted unicompartmental knee arthroplasty (UKA) leads to excellent functional results. Due to the reduced intraoperative visibility it is difficult to remove extruded bone cement particles, as well as bone particles generated through the sawing. These loose third body particles are frequently found in minimally invasive implanted UKA.

The aim of this study was to analyse the influence of bone and cement particles on the wear rate of unicompartmental knee prostheses in vitro.

Material & Methods

Fixed- bearing unicompartmental knee prostheses (n = 3; Univation F®, Aesculap, Tuttlingen) were tested with a customized four-station servo-hydraulic knee wear simulator (EndoLab GmbH, Thansau, Germany) reproducing exactly the walking cycle as specified in ISO 14243-1:2002. After 5.0 million cycles crushed cortical bone chips were added to the test fluid for 1.5 million cycles to simulate bone particles, followed by 1.5 million cycles blended with PMMA- particles (concentration of the third-body particles: 5g/l; particle diameter: 0.5- 0.7 mm). Every 500 000 cycles the volumetric wear rate was measured (ISO 14243-2) and the knee kinematics were recorded.

For the interpretation of the test results we considered four different phases: breaking in- (during the first 2.0 million cycles), the steady state- (from 2.0 million to 5 million cycles), bone particle- and cement particle phase.

Finally, a statistical analysis was carried out to verify the normal distribution (Kolmogorov-Smirnov test), followed by direct comparisons to differentiate the volumetric wear amount between the gliding surfaces (paired Student's t-test, p<0.05).


Orthopaedic Proceedings
Vol. 91-B, Issue SUPP_III | Pages 456 - 456
1 Sep 2009
Grupp TM Stulberg SD Kaddick C Maas A Schwiesau J Fritz B Blömer W
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Introduction: Total knee arthroplasty (TKA) has become a successful clinical treatment for patients in regard to relief of pain, correction of deformity and restoration of function with promising long term behaviour [Pradhan et al. 2006].

In TKA the generation of polyethylene wear debris is mainly affected by the factors design of the articulating bearing, contact stresses, kinematics, implant material and surface finish [McEwen et al. 2005].

The objective of our study was to evaluate the in vitro wear behaviour of fixed bearing knee designs in comprehension to the contact mechanics and resultant kinematics for different degrees of congruency.

Material and Methods: Wear simulator testing on 12 TKA devices has been performed according to ISO 14243-1 under load control. The knee replacements were tested in the fixed bearing configurations LC, CR and DD with different degrees of tibio-femoral congruency.

For gravimetric wear assessment the protocol described in ISO 14243-2 has been used, followed by a kinematic analysis of the single test stations.

The articulating contact and subsurface stresses have been investigated in a finite element analysis.

Results: The contact areas are increasing from Search® Evolution LC (144 mm2) to Columbus® CR (235 mm2) and Columbus® DD (279 mm2), whereas the peak surface contact stresses are decreasing from Search® Evolution LC (34.4 MPa) to Columbus® CR (20.9 MPa) and Columbus® DD (18.1 MPa). The estimated amount of wear has decreased from Search® Evolution LC (21.4 mg/million cycles) to Columbus® CR (8.9 mg/million cycles) and Columbus® DD (2.2 mg/million cycles).

The wear rates between the knee design configurations differ substantially and statistically analysis demonstrates a significant difference (p< 0.01) between the test groups in correlation with congruency.

Conclusion: The present study demonstrates the influence of different bearing types on contact stresses, abrasive wear and kinematics for three different degrees of tibio-femoral congruency under elimination of production, material and sterilization parameters.

Corresponding author: Dr.-Ing. Thomas M. Grupp

Research and Development: e-mail: thomas.grupp@aesculap.de


Orthopaedic Proceedings
Vol. 88-B, Issue SUPP_I | Pages 113 - 113
1 Mar 2006
Aicher W Gruender T Fritz J Weise K Gaissmaier C
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Aim: The healing capacity of human articular cartilage is very limited in the adult. Therefore tissue engineering techniques were developed to treat cartilage lesions. To it, autologous chondrocytes are harvested from the affected joint and expanded in vitro. During expansion chondrocytes may dedifferentiate, characterized by an increase in type I collagen and a decrease in type II collagen expression. Since high expression of type II collagen is of central importance for the properties of cartilage after transplantation, we investigated if the human platelet supernatants (hPS) containing PDGF and TGF-b or recombinant human bone morphogenetic protein-2 (BMP-2) may modulate the chondrogenic phenotype in monolayer cell cultures (2D) and in three-dimensional culture (3D) systems.

Methods: Chondrocytes from articular knee cartilage of 14 individuals (mean age 36.5 6.5 years) with no history of inflammatory joint disease were isolated and expanded under GMP conditions suitable for clinical purposes. The hPS was prepared from blood of 3 donors and pooled. Cells were seeded either in 2D cultures or embedded in alginate beads (3D) in presence or absence of hPS or recombinant human BMP-2 (generous gift of Dr. Hortschansky, Jena, FRG). After two weeks in culture, cells were harvested and analysis of the chondrogenic phenotype was performed using quantitative RT-PCR, immunocytochemistry and ELISA methods.

Results: Expansion of chondrocytes in primary culture (P0) did not yield populations of dedifferentiated or hypertrophic cells. Expanding cells in first subculture (P1) resulted in spontaneous reduction of type II collagen expression and increase in type I collagen mRNA amounts. Seeding P1 chondrocytes in 3D culture significantly reduced type I collagen, BMP-4 and IL-18 and maintained high type II collagen and BMP-2 encoding mRNA (p < 0.05). Reduction of IL-1b and elevation of IL-10 mRNA were noted but were statistically not significant. Addition of BMP-2 to 2D chondrocytes had no effect on type II collagen or IL-1b mRNA amounts (p < 0.05). In alginate cultures BMP-2 induced type II collagen and reduced IL-1b mRNA amounts. In contrast, addition of hPS containing PDGF and TGF-b, promoted mitotic activity in 2D and alginate cultures. The hPS reduced in 2D cultures type II and induced type I collagen expression. Even in alginate beads induction of type I collagen was detected.

Conclusions: We conclude that the chondrogenic phenotype is stabilized by BMP-2 more effectively in alginate beads but not in monolayer cultures. The hPS promotes proliferation of chondrocytes in vitro but induces elevated type I expression, an indicator of chondrocyte dedifferentiation.


Orthopaedic Proceedings
Vol. 88-B, Issue SUPP_I | Pages 105 - 105
1 Mar 2006
Fritz J Albrecht D Schewe B Krackhardt T Gaissmaier C Weise K
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Introduction: Within the last few years numerous operative procedures have been described aiming a biological repair of damaged articular cartilage. Current techniques are: Microfracture, Osteochondral Autografting (Mosaicplasty) and Autologous Chondrocyte Transplantation (ACT).

Several new studies have shown, that the defect size plays a major role in the clinical outcome of the different procedures. Thus, it makes sense to measure the size of a cartilage defect before indicating a certain method for biological repair.

Material and Methods: We have developed a software (beta-version) for measuring the size of a cartilage defect during a routine arthroscopy in a real-time mode. The programme is based on an Infrared-Navigation tool (Orthopilot, B.Braun-Aesculap, Germany).

In order to proof the reliability and the usefulness of this device, we carried out following study: in each of 6 cadaver-knees we performed 2 full-thickness cartilage defects (MFC and LFC) of different size.

In a first run 3 surgeons had to scope the joint and estimate the defect size with means of a scaled probe-hook. In a second run we performed a measurement of the defect with the Orthopilot™; finally an open measurement after arthrotomy was done to act as reference.

Results: Measurement of the cartilage defect size was clearly superior to an estimation by probehook. Especially the inter-observer difference between the surgeons was widely spread, whereas the max. mismeasurement with the Orthopilot was 2mm.

Discussion: Our study has shown, that navigational-assisted determination of chondral defects is superior to a simple estimation of a defect size by a probehook. Considering that the defect size is a crucial point in choosing the appropriate procedure for the treatment of cartilage defects, navigation devices like the CDM-software is maybe a helpful tool in making the right decision for a suitable method of biological cartilage repair.


Orthopaedic Proceedings
Vol. 85-B, Issue SUPP_III | Pages 265 - 265
1 Mar 2003
Hefti Fritz
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Purpose of the study: Congenital dislocation of the patella is a very rare condition. The pathology is inconsistent and treatment modalities are unclear. The aim of the study was to show the results of operative treatment of congenital dislocation of the patella.

Material and methods: 9 knee joints in 7 patients with congenital dislocation of the patella have been treated between 1989 and 1999. Additional diagnoses were Rubinstein-Taybe syndrome, Larsen syndrome, pteryg-ium syndrome and cerebral palsy in 1 patient each. The age at the time of surgery was 8.9 years on average (between 4.3 and 14.8 years). In 6 knees primary treatment was a medial shifting of the quadriceps muscle according to Stanisavljevic, in the other 3 a combination of lateral release according to Green, proximal quadriceps realignment according to Insall and either medial displacement of the tibial tuberosity according to Elmslie or a duplication of the patellar tendon according to Goldthwait had been done.

Results: The follow-up time was 6.4 years on average (between 2 and 12.5 years). 4 of 9 patellae remained stable after 1 operation, 3 remained stable after 2 operations and 2 remained unstable. 4 of the 9 knees were symptomatic at the time of follow-up. All patients were able to walk and to run and all had full extension. Apart from recurrence there were no major complications.

Conclusions: Permanent dislocation of the patella reduces the extension force of the quadriceps muscle significantly. Medial shifting of the quadriceps muscle according to Stanisavljevic gives the best chance to reduce the patella permanently. Postoperative taping, splinting and muscle-exercises are often necessary to get a stable situation.