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PubMed2003

Improvement of the reliability of ceramic hip joint implants.

The aim of this article is to present the optimization of a proof test procedure of ceramic hip joint ball heads. The proof test rejects defective samples in the production line before being implanted into human body. Thereby on every ceramic ball head a static load is applied, which is somewhat higher than the maximum physiological load. The magnitude of the applied load should not damage the samples which are free of flaws in the high stress area. The configuration of the proof test influences the stress distribution in the ball head, which should be similar to the physiological case. To determine the stress distribution, a non-linear finite element (FE) analysis was performed and the results were validated by measurements. With an iterative approach based on FE calculations the proof test configuration was optimized in such a way that the stress distribution in the ball head is similar to the stress distribution in vivo. In this study all ball heads showed very high fatigue resistance after being proof tested and fulfilled the requirements of the FDA (Food and Drug Administration, USA) described in the Guidance Document for the Preparation of Premarket Notifications for Ceramic Ball Hip System. The probability of a fracture of an implanted ceramic ball head can be decreased by the presented optimized proof test procedure. Latter can thus improve the reliability of ceramic hip joint ball heads. The study was supported by the KTI (Commission for Technology and Innovation, Switzerland).

Computer-Aided Design↗
PubMed2003

The strength of different fixation techniques for bicondylar tibial plateau fractures--a biomechanical study.

OBJECTIVE: To compare the mechanical strength of fixation of bicondylar tibial plateau fractures using internal and external fixation techniques. DESIGN: A randomised laboratory testing of fixation methods currently in clinical use. BACKGROUND: To reduce the high complication rate associated with the double plating, many surgeons have started to use less invasive techniques. However the literature comparing the mechanical performance of these methods is still scarce. METHODS: Bicondylar tibial plateau fractures were simulated on Sawbones tibiae and fixed with one of the five fixation methods: dual plating, a two-ring hybrid fixator with inter-fragmentary screws, a ring-bar hybrid fixator with inter-fragmentary screws, lateral plate and medial monolateral external fixator, lateral plate and medial inter-fragmentary screws. Following statistical power calculations, seven tibiae were used for each fixation method. The specimens were tested in cyclical compression to failure. The vertical subsidence in the medial or lateral plateau was measured using extensometers. RESULTS: In all cases the mode of failure was consistent with collapse occurring in the medial plateau. There was no significant difference in the failure load between dual plating and the two-ring hybrid fixator (4218 N and 4184 N respectively; P=0.28, t-test). Failure was seen at significantly lower loads with the other fixation systems. CONCLUSION: Weight-bearing mobilisation of the patient may be undertaken earlier with more confidence by using the double plating or two-ring hybrid fixator rather than other less strong techniques. The choice on which of these two methods to use may depend on tissue viability and surgeon preference.

Compressive Strength↗
PubMed2003

Early failure of the tissue engineered porcine heart valve SYNERGRAFT in pediatric patients.

OBJECTIVES: The first tissue engineered decellularized porcine heart valve, Synergraft (Cryolife Inc., USA) was introduced in Europe as an alternative to conventional biological valves. This is the first report of the rapid failure of these new grafts in a small series. MATERIALS AND METHODS: In 2001, 2 model 500 and 2 model 700 Synergraft valves were implanted in four male children (age 2.5-11 years) in the right ventricular outflow tract as a root. Two patients had a Ross operation and two had a homograft replacement. RESULTS: The cryopreserved Synergraft valves appeared macroscopically unremarkable at implantation. Recovery from surgery was uneventful and good valve function was demonstrated postoperatively. Three children died, two suddenly with severely degenerated Synergraft valves 6 weeks and 1 year after implantation. The third child died on the 7th day due to Synergraft rupture. Subsequently the fourth graft was explanted prophylactically 2 days after implantation. Macroscopically all four grafts showed severe inflammation starting on the outside (day 2 explant) leading to structural failure (day 7 explant) and severe degeneration of the leaflets and wall (6 weeks and 1 year explant). Histology demonstrated severe foreign body type reaction dominated by neutrophil granulocytes and macrophages in the early explants and a lymphocytic reaction at 1 year. In addition significant calcific deposits were demonstrated at all stages. Surprisingly pre-implant samples of the Synergraft revealed incomplete decellularization and calcific deposits. No cell repopulation of the porcine matrix occurred. CONCLUSION: The xenogenic collagen matrix of the Synergraft valve elicits a strong inflammatory response in humans which is non-specific early on and is followed by a lymphocyte response. Structural failure or rapid degeneration of the graft occurred within 1 year. Calcific deposits before implantation and incomplete decellularization may indicate manufacturing problems. The porcine Synergraft treated heart valves should not be implanted at this stage and has been stopped.

Animals↗
PubMed2004

Differences between the wear couples metal-on-polyethylene and ceramic-on-ceramic in the stability against dislocation of total hip replacement.

After total hip replacement an insufficient range of motion (ROM) can lead to contact between femoral neck and rim of the cup (= impingement) causing dislocation and consecutive material failure. The purpose of this study was to analyse the influence of different wear couples on the ROM and stability against dislocation. By means of a special testing device the ROM until impingement, the ROM until dislocation as well as the resisting moment against levering the head out of the cup were experimentally determined. Various total hip systems with cup inserts made of ceramic and polyethylene were comparatively examined in different implant positions. Maximum resisting moment as well as the ROM until impingement and dislocation were clearly influenced by the implant position. Furthermore, the stability against dislocation was affected by design parameters, whereas in the case of appropriate implant position differing wear couples (metal-on-polyethylene vs. ceramic-on-ceramic) had a minor impact. However, as shown by tests under lubricant conditions, ceramic-on-ceramic couples provided less dislocation stability in unfavourable implant position in comparison to metal-on-polyethylene. Therefore, ceramic-on-ceramic couples should only be applied in the case of optimised implant orientation preventing impingement and dislocation with subsequent material failure like chipping off or breakage.

Ceramics↗
PubMed2004

Bioprosthetic heart valves: the need for a quantum leap.

More than 250,000 bioprosthetic heart valves are being implanted annually. Although the majority of recipients are elderly developed-world patients, the most urgent need for tissue valves is in younger patients, where rapid degeneration of contemporary prostheses remains a serious obstacle. After decades of empirical and mostly futile attempts to extend the longevity of tissue valve prostheses, new insights and solutions are on the horizon. Aetiologically, a shift of focus from mineralization to immune responses and inflammation emerges. On the development side, new engineering approaches to both selective extraction of tissue components and cross-links are increasingly defining the new direction. In order to dramatically improve the performance of bioprosthetic heart valves, these new developments need to lead to a broad consensus for a paradigm shift in a hitherto rather stagnant field of medical research.

Animals↗
PubMed2001

Clinical performance characteristics of hemodialysis graft monitoring.

BACKGROUND: Regular monitoring of dialysis grafts is recommended, but the value of dialysis graft blood flow monitoring and venous pressures in predicting subsequent outcomes are controversial. METHODS: Over a period of one month, we performed simultaneous flow and venous pressure monitoring in 71 dialysis patients with polytetrafluoroethylene (PTFE) grafts. These patients were prospectively followed for one year. Receiver operating characteristic (ROC) curves were constructed to evaluate the performance of the various monitoring techniques. RESULTS: During the period of follow-up, there were 71 graft failures (30 angioplasty alone and 41 thrombosis followed by interventional or surgical revisions). Failed grafts had a lower blood flow rate [799 +/- 452 (SD) mL/min] when compared with those without failure (1019 +/- 485 mL/min, P = 0.05) Single static or dynamic venous-pressure monitoring were not predictive of graft failure. ROC analysis showed poor performance of graft flows in predicting graft failures over the short (30 days, AUC = 0.726, 95% CI, 0.509 to 0.942) and long term (one year, AUC = 0.630, 95% CI, 0.499 to 0.761). An adjustment of graft flows for systolic blood pressure or classification of graft based both on flows and venous pressure did not improve test performance. CONCLUSIONS: Although dialysis graft blood flow rates are statistically different in patients who have graft failure (graft angioplasty and surgery or thrombosis) versus those who do not, the performance characteristics preclude clinical decision-making from an isolated blood flow or venous pressure study.

Aged↗
PubMed2003

[Unicondylar knee arthroplasty--indications and outcome].

Continuous development of new materials, improved operative technique and exact patient selection lead to increasing survival rates of unicondylar sleigh arthroplasties during the last decade as it's demonstrated in this review on the literature. During the 80s the average survival rate after 5 years was 85 %, after 9 years 60 %. In the 90s significantly better results were noted with 5 and 10 years survival in more than 95 % of the cases. Thus, like current studies prove, unicondylar sleigh arthroplasties have reached the standard of complete surface replacement. Additionally minimal loss of bone stock, sparing of the crucial ligaments and of the femoropatellar joint as well as short operation time and low morbidity are advantages of these arthroplasties.

Equipment Failure Analysis↗
PubMed2003

The stress-strain behavior of coronary stent struts is size dependent.

Coronary stents are used to re-establish the vascular lumen and flow conditions within the coronary arteries; the typical thickness of a stent strut is 100 microm, and average grain sizes of approximately 25 microm exist in stainless steel stents. The purpose of this study is to investigate the effect of strut size on the stress strain behavior of 316 L stainless steel. Other materials have shown a size dependence at the micron size scale; however, at present there are no studies that show a material property size dependence in coronary stents. Electropolished stainless steel stent struts within the size range of 60-500 microm were tensile tested. The results showed that within the size range of coronary stent struts a size dependent stress-strain relationship is required to describe the material. Finite element models of the final phase of fracture, i.e., void growth models, explained partially the reason for this size effect. This study demonstrated that a size based stress-strain relationship must be used to describe the tensile behavior material of 316 L stainless steel at the size scale of coronary stent struts.

Arteries↗
PubMed1990

Clogging of biliary endoprostheses: a new perspective.

Endoscopic palliation with biliary endoprostheses is now an established treatment for benign and malignant strictures of the biliary tree. These endoprostheses, however, tend to clog with time. We investigated this problem by undertaking in vitro studies on stents of different designs made of different polymer materials. The stent that performed best was then tested in an in vivo trial. There was a direct relation in vitro between the frictional coefficient of a polymer and the amount of encrusted material. Catheters perfused in bacterially contaminated bile, irrespective of material and design, accrued significantly more sludge than catheters perfused with sterilised bile. The presence of side holes significantly increased the amount of sludge in the stents, but eliminated any differences between the various materials. We therefore investigated the effect of omitting side holes in a clinical trial which consisted of two groups of 20 patients each. The group treated with conventional stents accrued significantly more sludge in the stents than the group treated with experimental stents without side holes (p less than 0.05). The absence of side holes did not cause incomplete drainage or increase morbidity. Side holes are detrimental to stent patency, which is adversely affected by other factors including bacteria and proteins.

Aged↗
PubMed1987

Revision stapedectomy surgery.

Eighty-two revision stapedectomies were analyzed to determine causes of primary and revision stapedectomy failure. The specific cause of failure can often be anticipated preoperatively by analysis of the patient's audiogram, symptoms, type of prosthesis initially used, and the duration of time between initial surgery and the onset of symptoms. Guidelines for performance of revision stapedectomy are discussed.

Adolescent↗
PubMed1986

Societal and ethical considerations of artificial hearts.

The present state of artificial heart research and development is analyzed in light of public perceptions affected by accounts of the experiences of those who received the Jarvik-7. On the assumption that research will continue, it is argued that the therapeutic goals of the artificial heart can be realized, and funding be obtained, only in an atmosphere of positive publicity. To this end, formation of an association of companies involved in artificial heart R & D is recommended. Such a group would articulate voluntary standards and produce reports of advances in the field. Artificial hearts, it is noted in conclusion, have been effective as temporary assist devices in patients destined to receive heart transplants.

Ethics, Medical↗
PubMed2002

Comparison of wear, wear debris and functional biological activity of moderately crosslinked and non-crosslinked polyethylenes in hip prostheses.

The wear, wear debris and functional biological activity of non-crosslinked and moderately crosslinked ultrahigh molecular weight polyethylene (UHMWPE) acetabular cups have been com pared when articulating against smooth and intentionally scratched femoral heads. Volumetric wear rates were determined in a hip joint simulator and the debris was isolated from the lubricant and characterized by the percentage number and volumetric concentration as a function of particle size. The volumetric concentration was integrated with the biological activity function determined from in vitro cell culture studies to predict an index of specific biological activity (SBA). The product of specific biological activity and volumetric wear rate was used to determine the index of functional biological activity (FBA). On smooth femoral heads the crosslinked UHMWPE had a 30 per cent lower wear rate, but it had a greater percentage volume of smaller, more biologically active particles, which resulted in a similar index of FBA compared with the non-crosslinked material. On the scratched femoral heads the volumetric wear rate was three times higher for the moderately crosslinked UHMWPE and two times higher for the non-crosslinked UHMWPE compared with the smooth femoral heads. This resulted in a higher wear rate for the moderately crosslinked material on the scratched femoral heads. All the differences in wear rate were statistically significant. There were only small differences in particle volume concentration distributions, and this resulted in similar indices of FBA which were approximately twice the values of those found on the smooth femoral heads. Both materials showed lower wear and FBA than for previously studied aged and oxidized UHMWPE gamma irradiated in air. However, this study did not reveal any advantage in terms of predicted FBA for moderately crosslinked UHMWPE compared with non-crosslinked UHMWPE.

Acetylene↗
PubMed2003

Metal vs bioabsorbable interference screws: initial fixation.

Interference screws are used for graft fixation in anterior cruciate ligament reconstruction. There is current debate as to whether metal or bioabsorbable varieties provide the optimal results. This paper provides a critique of the single load-to-failure uniaxial tensile test data available in the literature, which provide the initial postoperative characteristics. Both metal and bioabsorbable screws were found to give similar levels of pull-out force and stiffness when used on similar types of graft material. Screws with bone-patellar tendon-bone grafts provided the greatest values, exceeding the forces transmitted through the native anterior cruciate ligament during normal daily activities. Hamstring grafts provided lower values, only being comparable with the forces of daily living. Consequently, this raises the question as to whether the rehabilitation regime of the hamstring patient must not be aggressive in the early postoperative stages when using either metal or bioabsorbable screws. This would ensure that the graft will not fail in the initial postoperative period before biological fixation occurs, which will then boost the strength to an acceptable level.

Absorbable Implants↗
PubMed2006

Finite element analysis of the resurfaced femoral head.

Failure of the resurfaced femoral head may occur in the short term owing to femoral neck fracture or in the long term owing to aseptic loosening as a result of strain shielding. Resurfacing arthroplasties are not all the same. In particular, there is considerable debate regarding the role of the metaphyseal stem and cementing technique. This study examines the influence of various metaphyseal stem configurations (diameter, percentage length in contact with bone, and bonded versus debonded) and cement mantle thickness on the load transfer within the femoral head. Resurfacing resulted in significant strain shielding in the superior femoral head and elevated strain in the superior femoral neck. Although the increase in strain in the femoral neck was significant, the mean strains were below the yield strain for cancellous bone. Peak strains were observed above the yield strain, but they accounted for less than 1 per cent of the total head-neck bone volume and therefore were unlikely to result in femoral neck fracture. Increasing the stem diameter and increasing the percentage stem length in contact with bone both increased the degree of strain shielding. Bonding the metaphyseal stem produced the most dramatic strain shielding, which also extended into the head-neck junction. In contrast, varying the cement mantle thickness had a negligible effect on the load transfer.

Biocompatible Materials↗
PubMed1997

Antibiotic prophylaxis in total hip arthroplasty. Review of 10,905 primary cemented total hip replacements reported to the Norwegian arthroplasty register, 1987 to 1995.

We have assessed the effect of different regimes of antibiotic prophylaxis on the survival of total hip implants, comparing antibiotics administered both systemically and in the bone cement, systemically only, in the bone cement only and with no antibiotics given. We studied 10,905 primary cemented total hip replacements, performed for osteoarthritis of the hip and reported to the Norwegian arthroplasty register between 1987 and 1995. Cox-estimated failure-rate ratios (FRR) are presented with adjustment for gender, age, the brand of cement, the prosthesis, the type of operating theatre and the operating time. For revisions performed for infection (39 operations), the lowest rate of revision was found among patients receiving antibiotic-containing cement plus systemic antibiotics (n = 5804). The revision rate for the 4586 patients receiving systemic antibiotics only was 4.3 times greater (95% CI 1.7 to 11.0, p = 0.001); in 239 with antibiotics in the bone cement only it was 6.3 times greater (CI 1.6 to 25.0, p = 0.003); and in the 276 who did not receive antibiotics it was by 11.5 times greater (CI 2.1 to 63.0, p = 0.002). Adjustment for the total amount of systemic antibiotic administered did not change the results. We also observed an increased revision rate for aseptic loosening (109 operations) comparing the systemic-only (FRR = 1.8, CI 1.1 to 2.9, p = 0.01) and the cement-only regimes (FRR = 2.6, CI 1.2 to 5.9, p = 0.02) with the combined dosage. Our findings show that systemic antibiotics combined with antibiotic-containing bone cement led to fewer revisions than the other methods.

Antibiotic Prophylaxis↗
PubMed2004

Research approaches for studying flow-induced thromboembolic complications in blood recirculating devices.

The advent of implantable blood recirculating devices has provided life-saving solutions to patients with severe cardiovascular diseases. Recently it has been reported that ventricular assist devices are superior to drug therapy. The implantable total artificial heart is showing promise as a potential solution to the chronic shortage of available heart transplants. Prosthetic heart valves are routinely used for replacing diseased heart valves. However, all of these devices share a common problem--significant complications such as hemolysis and thromboembolism often arise after their implantation. Elevated flow stresses that are present in the nonphysiologic geometries of blood recirculating devices, enhance their propensity to initiate thromboembolism by chronically activating the blood platelets. This, rather than hemolysis, appears to be the salient aspect of blood trauma in devices. Limitations in characterizing and controlling relevant aspects of the flow-induced mechanical stimuli and the platelet response, hampers our ability to achieve design optimization for these devices. The main objective of this article is to describe state-of-the-art numerical, experimental, and in vivo tools, that facilitate elucidation of flow-induced mechanisms leading to thromboembolism in prosthetic devices. Such techniques are giving rise to an accountable model for flow-induced thrombogenicity, and to a methodology that has the potential to transform current device design and testing practices. It might lead to substantial time and cost savings during the research and development phase, and has the potential to reduce the risks that patients implanted with these devices face, lower the ensuing healthcare costs, and offer viable long-term solutions for these patients.

Computer-Aided Design↗
PubMed1998

Revision of unicompartmental knee arthroplasty: outcome in 1,135 cases from the Swedish Knee Arthroplasty study.

From 1975 through 1995, 45,025 knee arthroplasties were recorded in the prospective Swedish Knee Arthroplasty study. By the end of 1995, 1,135 of 14,772 primary unicompartmental knee arthroplasties (UKA) for localized, mainly medial arthrosis had been revised. The Marmor/Richards and St. Georg sledge/Endo-Link prostheses were used in 65%. Mean age at revision was 72 (71) years. 232 revisions were performed as an exchange UKA (partial in 97) and 750 as a total knee arthroplasty (TKA). 153 were revised by other modes. In medial UKA, the indication for revision was component loosening in 45% and joint degeneration in 25% and in lateral UKA, the corresponding figures were 31% and 35%, respectively. In 94 cases, unicompartmental components were added to the initially untreated compartment, in 14 with partial exchange of a component. The CRRR was estimated using survival statistics. After only 5 years, the risk of having a second revision was more than three times higher for failed UKAs revised to a new UKA (cumulative rerevision rate (CRRR 26%) than for those revised to a TKA (CRRR 7%). This difference remained, even if those revised before 1985, when modern operating technique was introduced, were excluded (CRRR 31% and 5%, respectively). UKA is a safe primary procedure, when performed with well-designed components and modern surgical technique. It gives documented good patient satisfaction, range of motion, pain relief and relatively few serious complications. However, once failed, the knee should be revised to a TKA. This applies to most modes of failure. Not even joint degeneration of the unoperated compartment can be safely treated by adding contralateral components; CRRR after this procedure was 17%, while it was 7% when converted to a TKA.

Aged↗