[Transcorneal electrical stimulation in primary open angle glaucoma]. / Transkorneale Elektrostimulation bei primärem Offenwinkelglaukom.

Recently, reports have been published on the effectiveness of electrical stimulation in patients and experimental animal models with neurodegenerative ocular diseases. Our study included 14 patients with primary open angle glaucoma (POAG), who were randomized into one of three groups with 0% (sham, n = 5), 66% (n = 5) or 150% (n = 4) of their individual electrical phosphene thresholds. Patients were treated with transcorneal electrical stimulation (TES) for 30 min once a week for 6 consecutive weeks. Outcome measures of our study were the detection of possible adverse events and efficacy of TES using DTL electrodes in subjective and objective parameters of visual function under treatment. TES was tolerated well and no serious adverse events were registered relating to the treatment. One single adverse event was registered as appearance of an optic disc hemorrhage of a sham-stimulated eye. In summary, one significant increase of intra-ocular pressure in the 66% group was observed in comparison to the sham group (p = 0.04), without significant differences compared to the 150% group (both sham vs. 150% group and 66% vs. 150% group). This difference (mean difference compared to baseline of -2.33 mm Hg for the sham group and +0.97 mm Hg for the 66% group; REML) was not clinical meaningful. All other findings, including results of the visual field, were not statistically significant different between groups. It was shown that TES using DTL electrodes did not trigger adverse or serious adverse events in the stimulated groups in patients with POAG. Patients with POAG should currently receive TES only under study conditions.

[Effects of transcorneal electrical stimulation in patients with Stargardt's disease]. / Transkorneale Elektrostimulation bei Patienten mit Morbus Stargardt.

Stargardt's disease is an autosomal recessive inherited juvenile macular degeneration and at present no acknowledged science-based therapy is available for these patients. Recently, reports have been published on the effectiveness of electrical stimulation in experimental animal models and in patients with neurodegenerative ocular disease, particularly retinitis pigmentosa. This study included 12 patients with Stargardt's disease who were randomized into one of three groups (n = 4) with 0% (sham), 66% or 150% of the individual electrically stimulated phosphene threshold. Outcome measures of the study were safety and efficacy of transcorneal electrical stimulation (TES) with DTL electrodes in subjective and objective parameters of visual function under therapy. In general TES was well tolerated and no adverse or serious events were noted. Neither Ganzfeld, multifocal ERG, OCT nor visual field testing showed statistically significant changes in any group.

[Bilateral disc-like corneal opacity before cataract extraction]. / Seitengleiche, scheibenförmige Hornhauttrübung vor Kataraktextraktion.

An 81-year-old patient presented for cataract extraction of the right eye. In addition a bilateral disc-like corneal opacity was present which was classified as central cloudy corneal dystrophy of François. This rare and clinically unproblematic condition will be discussed.

A new DTL-electrode holder for recording of electroretinograms in animals.

PURPOSE: Contact lens electrodes (CLEs) are frequently used to register electroretinograms (ERGs) in small animals such as mice or rats. CLEs are expensive to buy or difficult to be produced individually. In addition, CLE's have been noticed to elicit inconstant results and they carry potential to injure the cornea. Therefore, a new electrode holder was constructed based on the clinically used DTL-electrode and compared to CLEs. MATERIAL AND METHODS: ERGs were recorded with both electrode types in nine healthy Brown-Norway rats under scotopic conditions. For low intensity responses a Naka-Rushton function was fitted and the parameters V(max), k and n were analyzed. The a-wave, b-wave and oscillatory potentials were analyzed for brighter flash intensities (1-60 scot cds/m²). Repeatability was assessed for both electrode types in consecutive measurements. RESULTS: The new electrode holder was faster in setting up than the CLE and showed lower standard deviations. No corneal alterations were observed. Slightly higher amplitudes were recorded in most of the measurements with the new electrode holder (except amplitudes induced by 60 cds/m²). A Bland-Altman test showed good agreement between the DTL holder and the CLE (mean difference 35.2 µV (Holder-CLE)). Pearson's correlation coefficient for test-retest-reliability was r=0.783. CONCLUSIONS: The DTL holder was superior in handling and caused far less corneal problems than the CLE and produced comparable or better electrophysiological results. The minimal production costs and the possibility of adapting the DTL holder to bigger eyes, such as for dogs or rabbits, offers with broader application prospects.

[Ceramic couplings in orthopedic surgery]. / Keramische Gleitpaarungen in der Orthopädie.

Ceramic materials have been used as a coupling in total hip arthroplasty since the 1970s to solve the problem of polyethylene particle disease. Several problems with the material and the design have been identified and solved. Using inlays and ceramic heads of the latest generation offers the possibility of reducing the wear rate to as low as 0.001 mm per year. The problem of ceramic fractures is rare. Recently due to the manufacturing process some zirconia ceramic heads have been problematic. New developments with other ceramics are discussed.

Immuno-allergological properties of aluminium oxide (Al2O3) ceramics and nickel sulfate in humans.

For more than 30 years aluminium oxide (Al(2)O(3)) ceramics have been used for implants in maxillofacial and orthopaedic surgery. Up to now, there are no reports and also no investigations on hypersensitivity reactions. In order to evaluate the aspects of immuno-allergological reactivity to aluminium oxide ceramics, skin testing and in vitro lymphocyte activation studies were performed. The patch test reactivity to a standard series of contact allergens and to an aluminium oxide (Al(2)O(3)) disk was examined in a consecutive series of 250 patients frequenting a University Dermatology Clinic. Furthermore, peripheral blood mononuclear cells (PBMC) of 15 nickel-allergic and 15 non-allergic individuals were cultured with medium alone, with the pan T-cell mitogen phytohemagglutinine (PHA) or with nickel sulfate (NiSO(4)). By additional presence/absence of Al(2)O(3) disk its influence on the cytokine secretion pattern and proliferative response was investigated. The results show that in contrast to a high frequency of delayed-type hypersensitivity to standard contact allergens, no allergic skin reactions to Al(2)O(3) ceramics occured. The IL-4 and IFN-gamma production in vitro remained almost unchanged by the presence of Al(2)O(3) disk as well as the proliferative response of PBMC of non-allergic individuals. Cellular reactivity of nickel allergic and non-allergic donors was partly enhanced upon contact to Al(2)O(3) disks.

[Computer-based motion simulation of total hip prostheses with ceramic-on-ceramic wear couple. Analysis of implant design andorientation as influence parameters]. / Computergestützte Bewegungssimulation an Hüftendoprothesen mit Keramik-Keramik-Gleitpaarung. Analyse der Einflussparameter Implantat-Design und Position.

OBJECTIVE: In THA, ceramic-on-ceramic wear couples are increasingly used. A restricted range of motion (ROM) due to unfavourable implant design or positioning may cause impingement or dislocation, which can result in failure of ceramic inserts. METHODS: By means of a 3-D CAD program different hip joint movements were simulated and the effects of ceramic hip implant design and position on the range of motion were analysed. RESULTS: To offer sufficient ROM and to minimise risk of impingement and dislocation, inclination angle of the acetabular cup should be 45 degrees, cup anteversion 15 degrees and stem antetorsion 0 degrees to 10 degrees. In regard to implant design, acetabular cups with slightly- recessed ceramic inserts should be used. Prosthetic systems with an elevated liner or with a mushroom-shaped femoral head are associated with limited ROM and increased risk of mechanical failure. The ratio of head to neck diameter should never be less than 2 : 1. Larger heads not only increase ROM, but also the stability of the prosthesis against dislocation. Thereby, the wear rate of ceramic-on-ceramic couples is not increased, in contrast to polyethylene. CONCLUSION: Considering certain criteria for ceramic hip implants regarding implant positioning, design and handling, ceramic-on-ceramic couples can be used with low risk of revision surgery and they can also reduce the prosthesis loosening associated with wear in young and active patients.

Alternate bearing surfaces: Ceramic-on-ceramic.

none.

Mismatched wear couple zirconium oxide and aluminum oxide in total hip arthroplasty.

A patient complained about a squeaking noise in his total hip arthroplasty. Clinical evaluation revealed good function, and there were no signs of loosening on the radiograph. Physiotherapy did not alter this phenomenon, and ultimately a revision was performed 42 months after the first surgery. The analysis of the retrievals revealed that a zirconium oxide ceramic head had been paired with a monolithic alumina ceramic cup. The cup showed large deviations from an ideal sphere but minor wear signs. The head exhibited heavy local damage in the articulation zone. This damage might have been caused by the observed unsatisfactory fit between cup and ball, resulting in high stress concentrations and increased wear of the zirconium head. The characteristics of the zirconium and aluminum ceramics pairing might have worsened the process. The combination of implants used in this retrieved wear couple was never approved. To prevent such problems, components of different manufacturers should never be mixed and matched unless explicitly stated.

Morphologic characteristics of periprosthetic tissues from hip prostheses with ceramic-ceramic couples: a comparative histologic investigation of 18 revision and 30 autopsy cases.

Pseudocapsules and interface membranes from 18 revision cases having hip prostheses with ceramic-ceramic couples and 30 autopsy specimens (6 with ceramic-ceramic couples, 7 with ceramic-polyethylene combinations and 17 with metal-polyethylene combinations) were histomorphologically analyzed, including a semiquantitative grading of the wear particles and histologic changes. Unlike the revision cases, which usually showed ceramic wear particles in the adjacent tissues, only half of the autopsy cases revealed ceramic wear. As compared to the ceramic-polyethylene and metal-polyethylene couples, the alumina on alumina combinations showed a thinner synovial layer with reduced villous transformation and smaller infiltrates of macrophages and necroses, which can be explained by the absence of polyethylene wear. Metal-polyethylene couplings produced more than twice as many polyethylene wear particles with correspondingly more marked foreign body reaction than the ceramic-polyethylene couplings.

Initial stability of modular acetabular components. Comparative in-vitro study with polyethylene and ceramic liners.

Modular acetabular components with alumina ceramic liners are currently used in total hip arthroplasty, but concerns have emerged regarding their high stiffness, which could cause impairment of stability, stress-shielding phenomena, and loosening. The purpose of the present biomechanical investigation was to compare the in-vitro initial stability of a modular press-fit acetabular component using a polyethylene liner and using an alumina liner. The initial stability was investigated by measuring the micromotion between the implant and the acetabulum during the application of physiological load (2.39 kN). The micromotion of the acetabular component was investigated in 10 acetabuli using a polyethylene liner and in 10 acetabuli using an alumina liner. Micromotion was assessed at the level of the Os ilium, Os pubis, and Os ischium using 3 electromagnetic transducers. The transducers have a sensitivity of 1 micron and a range of measurement of 500 microns. All implants have been fixed on human pelves made of polyurethane. Measurement of implant micromotion showed stable conditions at the level of the three main sectors of the acetabulum during all tests. No statistically significant differences of results were observed between the group of specimens with polyethylene liner and the group of specimens with alumina liner. The mean micromotion values of the uncemented cups were similar to the mean micromotion values of 10 cemented cups investigated to achieve comparative data of stability. In conclusion, the modular acetabular components inserted using an alumina liner showed a satisfactory initial stability in-vitro. The results do not contrast with those achieved using the same cup inserted with a polyethylene liner.

Long-term results after operative treatment of femoral neck fractures with ceramic head prostheses.

From 1985-1990, a total of 277 elderly patients underwent hemiarthroplasty using a ceramic head prosthesis. Average patient age was 81.7 years. Of these, 77 patients were available for follow-up examination in 1993. A standardized score was calculated assessing activity, gait, and hip pain; the average score was 58 out of 78 possible points. Three patients had hip pain, and in 4 patients, radiographic examination revealed protrusio acetabuli. Two of 4 patients underwent revision surgery for replacement of the cup, leaving the stem in situ. Because of the small number of prosthetic-related complications, hemiarthroplasty using a ceramic head prosthesis is the recommended surgical treatment for femoral neck fractures in elderly patients. In the rare patient with protrusio acetabuli, revision surgery can be performed to replace the cup, leaving the stem in situ.

[Investigation of explanted hip and acetabulum hip prostheses]. / Untersuchung von explantierten Kugelköpfen und Pfannen von Hüftendoprothesen.

Retrieved ceramic femoral heads and acetabular cups were investigated. On the basis of the case studies, the reasons for revision are discussed. Wear patterns and wear rates were found to differ from those observed in hip simulating testing. Monolithic ceramic cups showed a high wear rate. Owing to their limited range of motion, ceramic "mushroom heads" are associated with impingement that leads to a high risk of cup loosening, high wear rates and in vivo fractures. The combination of ceramic "mushroom heads" and cups is not recommended. An evaluation of complications shows that some can be explained by patient behaviour--e.g. Japanese sitting position, horse riding. Designers need to develop new concepts offering a larger range of motion, for example, with head diameters of 32 and 36 mm that reduce the risk of impingement, subluxation and dislocation, while increasing the range of motion. The potential of ceramic/ceramic coupling has been known since the 70s, and ceramic concepts for total hip replacement are currently experiencing a renaissance, although further developments are still possible.

Ceramic femoral head retrieval data.

In the 1970s it was first realized that the properties of alumina ceramics could be exploited to provide better implants for orthopaedic applications. Applications depend on the fact that ceramics provided wear characteristics suitable for bearing surfaces in total hip replacement. Resultant orthopaedic use had more than 20 years' clinical success. To date more than 2.5 million alumina femoral heads have been implanted. Published reports of fracture rates of the alumina heads range between 0% for ceramics manufactured after 1990 and 13.4% for ceramics manufactured before 1990. These high fracture rates were caused by materials manufactured by companies that are not on the market today. These old aluminas had a low density, had a very coarse microstructure, and were not in compliance with specifications that are valid today. Materials scientists have substantially improved the mechanical strength of alumina. There are three generations of medical grade aluminas. The latest generation is an alumina that is hot isostatic pressed, laser marked, and proof tested. This material has been on the market since 1994. The fracture rates of the most commonly used ceramics have been analyzed by various groups, and are based on .5 million femoral heads to 1.5 million femoral heads. The fracture rate of ceramic Biolox femoral heads are 0.026 % for first generation alumina, 0.014% for second generation alumina, and 0.004% for femoral heads manufactured after 1994. Analyzing the clinical experience of more than 20 years, it can be concluded that all the improvements have produced reliable ceramic femoral heads.

[Ceramic acetabulum for hip endoprostheses. 8: Revisions]. / Keramische Pfannen für Hüftendoprothesen. Teil 8: Revisionen.

For total hip replacement, ceramic femoral heads and acetabular liners are being used with success. However, reports of revision surgery necessitated by fractures or marked wear of ceramic components are still being published. The revision rate due to fracture is less than 0.01%, and much lower than for other complications. Nevertheless, improvement of safety remains a topic of discussion. This article reviews the results of investigations of explanted ceramic heads and liners, and discusses the problems caused by ceramic wear and chipping. Recommendations for revision surgery in such cases are given.

[Ceramic cups for hip endoprostheses. 6: Cup design, inclination and antetorsion angle modify range of motion and impingement]. / Keramische Pfannen für Hüftendoprothesen. Teil 6: Pfannendesign, Inklinations- und Antetorsionswinkel beeinflussen Bewegungsumfang und Impingement.

The present investigation focuses on total hip replacement using ceramic acetabular components. The relationship between the position of the cup and the range of motion (ROM) was investigated. A limited range of motion may cause impingement, which is defined as contact between the femoral neck and the rim of the acetabular cup. Impingement may result in wear, chipping, fracture or dislocation of the femoral head. Joint movements were simulated in a three-dimensional CAD program. The results obtained underscore the importance of correct positioning and design of the cup for achieving a ROM as close to the physiological situation as possible. With ceramic cups, the inclination angle should not be more than 45 degrees, and the antetorsion angle between 10 and 15 degrees. If the cup is too vertical, the risk of dislocation and fracture of the ceramic increases. If, on the other hand, the angle of inclination is too small, flexion and abduction will be greatly limited. The study shows that acetabular components with non-recessed ceramic inserts should not be used. Slight recession of the insert helps to avoid impingement. The ROM is reduced and the risk of impingement appreciably increased when mushroom-shaped femoral heads (XL heads) or ceramic inserts protected by a polyethylene ring are used.

[Experiences with a hydroxyapatite-coated, macroporous surface hip endoprosthesis]. / Erfahrungen mit einer Hydroxylapatit-beschichteten, makroporös strukturierten Hüftendoprothese.

INTRODUCTION: Cementless hip arthroplasty is not completely satisfactory--even with macroporous structured surface. Medium term results are sometimes disappointing because of insufficient secondary stability. Thus our aim was to improve fixation by additional coating with hydroxyapatite. METHODS: 200 consecutive patients who had hydroxyapatite-coated cementless hip replacement with a macroporous hip prosthesis (09/92-03/96) were studied prospectively. All patients were included in a prospective follow up schedule according to the criteria of Johnston et al. As measure of clinical outcome we calculated Harris Hip Score as well as Enghs Score to assess radiologic fixation and stability. RESULTS: 91% could be followed up regularly. No revision because of aseptic loosening had to be done. Analysis of clinical results showed almost painless patients from early after the operation--especially no thigh pain. Average HHS after 2 years was 97. Radiological evaluation showed early and complete osteointegration of all components. According to Engh-Score they are stable and well fixed. CONCLUSION: HA coated macroporous implants provide some striking advantages, which encouraged us to continue with this system. By early and secure bony ingrowth a fibrous interface is avoided and thereby also long-lasting thigh pain.

[Ceramic acetabular cups for hip endoprostheses. 7: How do position of the center of rotation and the CCD angle of the shaft modify range of motion and impingement?]. / Keramische Pfannen für Hüftendoprothesen. Teil 7: Wie beeinflussen Lage des Rotationszentrums und CCD-Winkel des Schaftes Range of Motion und Impingement?

The range of motion (ROM) of total hip prostheses is influenced by a number of parameters. An insufficient ROM may cause impingement, which may result in subluxation, dislocation or material failure of the prostheses. In a three-dimensional CAD simulation, the position of the centre of rotation and the CCD angle of the stem were investigated. Displacement of the centre of rotation of the femoral head may be due to wear (PE cups) or to the design of the prosthesis (ceramic cups). Stems of widely differing design have been developed and implanted. The results of the present study demonstrate that the ROM is clearly reduced by increasing penetration of the femoral head. At an inclination angle of 45 degrees, a depth of penetration of 2 mm restricts flexion by about 15 degrees, and a depth of penetration of 3 mm by about 30 degrees. At smaller angles of inclination the ROM is reduced and flexion and abduction are associated with an increased risk of impingement. With steeper acetabular cup inclinations, the risk of impingement decreases, but dislocation, the risk of rim fractures (ceramic cups), and wear and penetration rates (PE cups) increase. The CCD angle of the stem should be oriented to the anatomical situation. At high CCD angles (> 135 degrees), flexion is clearly limited, in particular when there is penetration of the femoral head. For modern total hip arthroplasty, prosthetic systems characterised by precise positioning of components, minimum wear, slightly recessed inserts, and appropriate CCD angles should be used.

Tribological investigations of the wear couple alumina-CFRP for total hip replacement.

Wear debris is the main reason for aseptic loosening in total hip. Most troublesome is the wear of polyethylene cups. Ceramic femoral heads were introduced about 20 years ago. The combination ceramic-on-polyethylene reduces the wear rate and the loosening rate. But cups of polyethylene are still the weakest link in a hip prosthesis. Carbon fibre reinforced plastic (CFRP) was proposed as an alternative for polyethylene. Various test were performed to study the combination metal-on-CFRP, zirconia-on-CFRP, and alumina-on-CFRP. The simulator tests showed that the wear rate of alumina-on-CFRP is in the order of 1-3 microm per year. Based on investigation of retrieved implants the wear rate is 6.3 microm per year. Based on these results the combination alumina femoral heads (Biolox-forte) and CFRP cups (Caproman) could be approved for total hip replacement.

[Ceramic cups for hip endoprostheses. 4: Never mix and match]. / Keramische Pfannen für Hüftendoprothesen. Teil 4: Never mix and match.

Femoral ball heads for total hip replacement are made of various materials, e.g. cobalt chrome alloy, coated metal, or various ceramics. Standard sockets are made of polyethylene, alumina ceramics, or CFRP. Due to tribological reasons some of the combinations of head and socket that seem possible are prohibited. The approved and prohibited combinations are reviewed and reasons for not approving are discussed.