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Ossiculoplasty with composite prostheses. Overview and analysis.

Aeration of a mucosa-lined tympanic cavity is essential for a functioning middle ear. Extrusions of even the best-designed prostheses occur from abnormal middle ear conditions such as atelectasis, middle ear fibrosis, recurrent cholesteatoma, tympanic membrane perforation, and otitis media. Various polymers have been developed in an attempt to maximize prosthetic biocompatibility and ease of use while minimizing the chance of extrusion. One such polymer is a composite of hydroxyapatite and Silastic, known as Flex H/A. This material has been incorporated into two ossicular prostheses, the Universal Plus and the Causse Flex H/A prostheses. Certainly, refinements will continue to be made in the chemical makeup of the bioceramics in order to achieve optimal biocompatibility. In addition to biocompatibility, cost containment issues have influenced the development of ossicular prostheses. A universal prosthesis eliminates the need to stock multiple designs, thereby reducing the cost to institutions. One of the greatest challenges in the future will be to define the appropriate prosthetic design for optimal sound transmission. Consideration of prosthesis weight, head size, and footplate attachment are future research questions that need to be addressed in a scientific biologic model.

Biocompatible Materials↗

Implant treatment in partially edentulous patients: a report on prostheses after 3 years.

There has been an increasing interest in the use of implants for partially edentulous patients. This introduces other biomechanical situations than those experienced in completely edentulous patients. In a prospective multicenter study, 521 implants in 154 patients were loaded with 197 free-standing prostheses. The patients have been followed for 3 years. The cumulative success rate for the prostheses was 94.8% and for the implants it was 93.9%. Most of the lost prostheses were only supported by two implants. A frequent technical complication was fracture and loosening of gold screws, which was more frequent in prostheses supported by only two implants.

Adolescent↗

Acute postoperative block of mechanical prostheses: incidence and treatment.

Acute intermittent postoperative block of mechanical prostheses is a rare and life-threatening complication; its incidence and treatment are not well defined. Between January 1975 and June 1991, 2839 mechanical prostheses were implanted using the same technique: mattress suture for mitral valve replacement and simple suture for aortic valve replacement. Prosthetic block occurred in eight patients: four following mitral valve replacement and four after aortic valve replacement. The blocked prosthesis was always a tilting disc valve (five Sorin, two Björk-Shiley and one Medtronic). The event occurred over a time interval of 6-48 h (mean(s.d.) 17.3 (15.6)h). All patients having mitral valve replacement needed emergency prosthetic replacement. In aortic valve replacement, reoperation was necessary in two patients; the disc block disappeared in the others. All patients are alive with a follow-up ranging between 3 and 168 (mean 32.5) months. No structural failure was found in explanted prostheses leading to a diagnosis of extrinsic block. The overall incidence of this complication was 0.28% (eight of 2839); 0.24% (four of 1645) for mitral valve replacement and 0.33% (four of 1194) for aortic valve replacement respectively (n.s.). It was exclusively related to tilting disc valves (0.44%; eight of 1830) versus ball and bileaflets valve (0 of 1009). In mitral valve replacement reoperation on patients is mandatory; in aortic valve replacement patients the left ventricular pressure itself can overcome the prosthetic block. Attention should be paid to valve excision and suture techniques as tilting disc prostheses are more vulnerable to extrinsic block. Furthermore, their use is contraindicated in redo operations and mitral valve replacement with total or partial preservation of mitral apparatus.

Adult↗

Clinical results with resin-bonded prostheses and an adhesive cement.

The longevity of resin-bonded prostheses made of a high-gold alloy and bonded with Super-Bond C&B (C&B Metabond) were tested clinically. Minimal preparation and large surface area of retainer coverage were used. The inner surfaces of the retainers were air abraded with aluminum oxide and heat treated in an oven at 400 degrees C to get an oxidized layer for bonding. The results of the adhesive technique were unsatisfactory compared with studies with resin-bonded prostheses using conventional mechanical retention techniques and nonadhesive resin cements. All fractures were at the resin-metal interface. Early debonds occurred; seven of 13 prostheses were detached after 11 months. The median survival time was only 9 months. The adhesion of resin-bonded prostheses must still be based on mechanical retention between cement and metal, because a way of attaining good durability of the bonding joints to water with Super-Bond is yet to be found.

Adult↗

[Long-term follow-up with various Dacron bifurcation prostheses. 5-years results of a prospective randomized study].

In the frame of a prospective randomised study various Dacron bifurcation prostheses with or without velours or with or without gelatin impregnation were implanted in one hundred patients. Fifty-four patients could be reexamined clinically and sonographically after an average of 66 months. A total of 23 patients had died during the period of observation. A comparison of the Fontaine stages during reexamination indicated in 72.3% of cases an operation-related improvement as compared to the condition in the preoperative stage. Sonographically, an average dilatation of 17.3% could be proved. A significant difference due to material or impregnation was not observed. After 72 months the limb salvage amounted to 83.0%. A comparison of the various types of prostheses regarding their limb salvage could indicate no significant difference in the course of 72 months. Based on the only slightly differing results within the period of observation, only the more comfortable intraoperative handling leads to giving preference to the use of double velours prostheses in comparison to prostheses without velours. A positive influence of impregnation with gelatin could not be established.

Adult↗

Sound spectral analysis of prosthetic valvular clicks for diagnosis of thrombosed Björk-Shiley tilting standard disc valve prostheses.

To evaluate clinical usefulness of sound spectral analysis in the early detection of prosthetic thrombosis, we analyzed specific patterns of thrombus formation in Björk-Shiley tilting standard disc prostheses in relation to the sound spectral analysis of their click sounds. Among a total of 365 Björk-Shiley tilting standard disc prostheses, nine became thrombotic. These consisted of seven prostheses in the mitral position and two in the aortic position, and the affected valves were replaced in all cases. The sound spectral analysis system includes a wide-frequency microphone and a sound spectral analyzer. To quantify the amplitude of the metallic clicks that are specific to the prosthetic valve sounds, we used a normalized maximal frequency as a diagnostic parameter for valve thrombosis. Thrombus formation was localized at the minor strut in two cases, and these demonstrated abnormally low normalized maximal frequency values only on opening clicks. In four cases thrombus formations were noted at both minor and major struts, and these showed abnormally low normalized maximal frequency values on both opening and closing clicks. In two cases with pannus formation, no abnormalities were found by sound spectral analysis. In one case, which had demonstrated abnormally decreased normalized maximal frequency values of both opening and closing clicks, the normalized maximal frequency values were normalized after thrombolytic therapy, suggesting resolved thrombosis. Reoperation, which was performed for concomitant complication of perivalvular leak, revealed no noticeable thrombus formation. The thrombi were seen on the minor strut during surgical procedures in all cases in which valve thrombosis was indicated by the sound spectral analysis. Therefore, the minor strut is considered to be the prevalent area of thrombus formation, and diagnosis could be made after observation of abnormally low normalized maximal frequency on opening clicks. We found the sound spectral analysis to be an extremely useful diagnostic tool for early detection of thrombosis in the Björk-Shiley tilting standard disc prostheses, especially because the opening clicks of the tilting disc valve were too low in amplitude for auscultation to detect the existence of mild abnormality.

Adolescent↗

Ossiculoplasty using the black hydroxylapatite hybrid ossicular replacement prostheses.

The problems of ossicular reconstruction in chronic ear surgery have led to the development of new ossicular replacement prostheses. Improvements in biocompatibility and design led to the development of hydroxylapatite hybrid (HaH) ossicular replacement prostheses. The senior author's (M.E.G.) experience with the Black HaH prostheses is reviewed. Sixty cases are grouped by procedure and prosthesis (19 TORPs and 41 PORPs) with a minimum follow-up of 1 year. Audiometric data are analyzed to determine the success rate in air-bone gap closure. Complication and extrusion rates are reviewed. These results are compared against those obtained using other prostheses using similar criteria, and this report serves as a follow-up on a previous paper on this subject by the senior author.

Adult↗

Structural integrity assessment of heart valve prostheses: a damage tolerance analysis of the CarboMedics Prosthetic Heart Valve.

The design of mechanical heart valve prostheses must satisfy three basic requirements: biocompatibility, efficiency and durability. Over the past 25 years of clinical use, pyrolytic carbon has proven to be biocompatible and thromboresistant, and is therefore the material of choice for mechanical heart valve prostheses. However, in recent years the material has been questioned in this application because it is brittle and susceptible to subcritical crack growth. This has raised concerns regarding the structural reliability of prostheses constructed from this material. This paper describes the application of the damage tolerance methodology to assess the structural integrity of heart valve prostheses made of pyrolytic carbon. In particular, an analysis of the CarboMedics Prosthetic Heart Valve (CPHV) is presented. A new measure of fatigue lifetime, the fatigue safe-life index, is introduced. Additionally, the degradation of structural integrity from cavitation erosion is examined. It is shown that structural integrity, especially for brittle materials, is not just a function of design, but involves the entire manufacturing process. The damage tolerance method can be applied to assess and ensure the structural integrity of pyrolytic carbon prosthetic heart valve components.

Biocompatible Materials↗

Telescopic prostheses for implants.

This retrospective study investigated the outcome of 73 telescopic implant-supported fixed prostheses. Fifty-four prostheses were entirely cement-retained, and 19 incorporated a screw-clamping unit. The rate of complications was low and in most cases minor in nature. Cement-retained prostheses involving a distal cantilevered extension required the greatest postoperative maintenance. Despite the small number of combined screw- and cement-retained prostheses, the lack of complications and ease of retrievability make this approach worthy of further study.

Adult↗

Macroscopic aspects of cloth-covered Starr-Edwards prostheses at reoperation: what the precursory valve teaches us.

BACKGROUND AND AIMS OF THE STUDY: Cloth-covered Starr-Edwards ball valves were the first choice in prosthetic substitution at the authors' institution between June 1968 and March 1977. This study investigated, retrospectively, macroscopic aspects of the prostheses at reoperation. METHODS: Among 59 survivors who underwent isolated aortic or mitral valve replacement, 12 required reoperation for valve dysfunction (five aortic valve replacements, seven mitral valve replacements). Reoperation was necessitated by valvular endocarditis, paravalvular leak, hemolysis, thromboembolism, orifice stenosis attributable to pannus, and inappropriate sizing related to growth and thrombus. The mean time to reoperation was 11.7 +/- 6.2 years after initial surgery (range: 2 years 4 months to 21 years 8 months). RESULTS: Marked cloth wear was observed in all aortic prostheses, but only slight wear in mitral valves. Pannus formation was observed around the orifice in both aortic and mitral prostheses, but strut cloth was not extensively covered by autologous tissue. In mitral valves, strut cloth was only slightly worn and less loose than that of the aortic valve. These changes notably affected prosthetic valve function, the most significant problem in mitral prostheses being thrombus (four of seven valves). CONCLUSIONS: Pannus formation and thrombus caused by the reaction of the patient's tissues remain major problems in the use of artificial valves, and require further work for their improvement.

Adolescent↗

[10-year survival of Zweymüller total prostheses in primary uncemented arthroplasty of the hip].

PURPOSE OF THE STUDY: To provide clinical and survival results of a consecutive series of primary total hip arthroplasties (THA) performed with the Zweymüller grit-blasted titanium total hip prostheses of the 2 last designs (Hg and Alloclassic-SL), and to compare the 10-year survivorship with those of other prostheses either cemented or cementless. MATERIAL AND METHODS: Of 238 index THAs, 213 hips have been prospectively studied with a 2 year minimum follow-up (average, 6.5 years; range, 25 to 146 months). Mean age was 63 years. Hip arthrosis was the main diagnosis (88 per cent). RESULTS: Intra-operative fracture rate (n = 238 primary THAs) was 6.3 per cent, 2.9 per cent and 1.3 per cent, for the greater trochanter, the upper femur, and the acetabulum, respectively. Early dislocation rate was 4.6 per cent. Average Postel-Merle d'Aubigné-Charnley Hip Score raised from 11.3 points pre-operatively, to 16.7 points at last follow-up. Clinical results were graded excellent and good in 93 per cent of hips, fair in 5.1 per cent, and poor in 1.9 per cent. At least 19.5 per cent of stems subsided 2-10mm within the first 2 years. Reactive and lucent lines have been noted in 33 hips (15.5 per cent) in complete Gruen zones 1 and 7, and in 4 hips (1.9 per cent) extending in zones 2 and 6. 1 Hg and 1 SL components definitively failed to stabilize, and have been revised, at 5.6 and 2.4 years, respectively. Proximal mild stress shielding and Brooker III and IV heterotopic bone formation were noted in 11.7 per cent and 12.7 per cent of hips, respectively. Beside one immediate revision, 4 threaded components failed to achieve initial stability. Two migrated within the first 2 years, then stabilized with good clinical results at 8.5 and 5.2 years. The 2 others failed their osseointegration, with only 1 revision thus far. Most immediate post-surgery bone-implant acetabular gaps in 57.8 per cent of hips, have nearly disappeared at last control, with residual lucencies around 7 per cent of rings. Annual linear wear rate superior to 0.2 mm per year could be detected in only 1 ceramic-PE bearing surfaces, but femoral osteolysis was seen in 3 cases. There has been no ceramic head breakage thus far. At 10 years, survivorship of the 238 index THAs with "pain graded < 5" and "revision for clinical failure" (dislocation excluded) as end point was 95.8 per cent and 98 per cent, respectively. With "definite loosening" (radiographic failure) as end point, 10 year survivorship was 99.1 per cent for the stems and 98.6 per cent for the threaded cups. DISCUSSION: Once osseointegration apparently occurred, the authors have never observed any secondary migration indicating failure of the bone-implant anchorage. The femoral implantation technique was critical and improved following an unavoidable learning curve. Liner disassociation, evolutive acetabular lucencies, worrisome wear and osteolysis were not of great concern thus far. Results of these grit-blasted threaded cups are much better than those of former smooth screw rings. CONCLUSION: Ten year survivorships of the Zweymüller cementless prostheses in primary THA are better than those of former cemented or cementless prostheses, and are within the range of the best results published at equivalent follow-up with hybrid reconstructions with use of stems cemented with up to date technique and hemispheric cementless press-fit cups with screw fixation.

Adult↗

Effects of magnetic resonance imaging fields on stapedectomy prostheses.

Seven different types of widely used metallic stapedectomy prostheses were individually placed on a millimeter scale in a plastic Petri dish. The Petri dish was moved within the core and around the magnet of a 1.5-tesla magnetic resonance imaging unit (General Electric Sigma). No movement of any of the prostheses was seen. We conclude that there is no apparent danger of these prostheses becoming displaced in stapedectomy patients subjected to the electromagnetic fields of magnetic resonance imaging units.

Electromagnetic Fields↗

Systemic effects of implanted prostheses made of cobalt-chromium alloys.

Systemic effects of Co-Cr alloy/polyethylene hip joint prostheses were investigated using instrumental neutron activation to determine the concentrations of up to 16 elements. First, in a prospective study whole blood and serum taken from 10 patients from 1 day before to 90 days after implantation were analyzed. Secondly, in a retrospective study whole blood and serum from 23 patients who had had prostheses in place for up to 18 years were analyzed. For comparison, normal trace element levels in humans were determined by analyzing whole blood and serum from 21 patients. Finally, various tissues and organs from two decreased implant patients were analyzed and compared with normal concentrations obtained from the analysis of five "normal" patients without implants. In agreement with other recent investigations, our analyses of normal serum, whole blood, tissues, and organs show that most previously defined "normal" trace element concentrations were too high, chiefly owing to contamination and insufficient blanks. A detailed discussion shows that for many elements the ranges of normal concentrations have to be revised. This conclusion is of particular importance with respect to the sometimes conflicting earlier reports of systemic effects of metal prostheses. In the work reported here, both the prospective and the retrospective investigations of serum and whole blood showed massive Co enrichments as a consequence of implant corrosion. The data show a wide range of individual burdening, ranging from practically no effect to the most extreme values. The analyses of tissues from the vicinity of the implants in the two deceased implant patients showed strong local effects of Co, Cr, Zr, and Hf, the latter two elements originating from the X-ray contrast media in the bone cement. The analyses of organs revealed significant Co and Cr enrichment in several tissues and organs. Consequently, it can be seen that implant corrosion is not an occurrence of merely local significance, but one that affects the trace element status of the entire organism.

Bioprosthesis↗

Expanding prostheses in conservative surgery for lower limb sarcoma.

Conservative resection of bone sarcoma in the lower limbs in children is very likely to be followed by a progressive problem of leg length inequality resulting from removal of the growth cartilage. To overcome this we have been using an expanding prosthesis and we report our experiences during the period 1985-1996. The prostheses are made of titanium and comprise 3 parts: an articular component, an expanding mechanism, and tibial and femoral stems. The degree of possible lengthening of the prostheses is virtually unlimited, and they can be inserted in children of 5 or more years of age. We report the use of 28 prostheses in patients aged from 5 to 18 years, of which 4 were tibial, 5 total femur, and 16 distal femur. There were 6 Ewing's sarcoma, 21 osteosarcoma, and 1 synovial sarcoma. The average follow-up was for 5 years. Five patients died from their disease, and 21 benefited from an average lengthening of 2.6 cm (range: 2 mm-120 mm). Using the Société Européenne des Tumeurs Osseouses (EMSOS) criteria, the functional results were excellent or very good in 16, fair in 7 and bad in 5. Five patients developed an infection; one required amputation and the others received a new expanding prosthesis. We conclude that an expanding prosthesis is an excellent alternative to amputation in young children. However, the risk of infection associated with repeat surgery has led us to develop a prosthesis which can be lengthened externally, without the need for reopening the wound.

Adolescent↗

Decreased collagen type I/III ratio in patients with recurring hernia after implantation of alloplastic prostheses.

BACKGROUND: Abnormal collagen metabolism is suspected to play an important role in the pathogenesis of recurring inguinal and incisional hernias. Whereas alloplastic prostheses are nowadays routinely used, the quantity and quality of collagen formation after repair in humans has not been analysed in a large cohort. METHOD: Seventy-eight prostheses (Prolene, Atrium, Marlex, Vypro, Mersilene, Gore-Tex) implanted for inguinal and incisional hernia repair were explanted because of recurrence, chronic pain or infection. The mean implantation period was 17.9+/-11.2 (range 0.5-48) months. Collagen formation was investigated quantitatively (collagen-protein ratio) and qualitatively (collagen type I/III ratio). Results were related to clinical data that included gender, age, implantation period, indication for implantation/explantation, type and location of prosthesis. RESULTS: Mean collagen-protein ratio was 45.3+/-8.5 microg/mg, with significant differences between male (43.8+/-9.1 microg/mg) and female tissue samples (48.1+/-6.8 microg/mg, P=0.033). The mean collagen type I/III ratio of all samples investigated was 2.1+/-1.4. Samples explanted for recurring hernias exhibited a significantly decreased ratio (1.3+/-0.7, P<0.05) compared to samples explanted because of pain (3.4+/-1.2) or infection (2.9+/-1.6). Multivariate analysis excluded independent effects of age, gender, indication for implantation of prostheses, location and implantation period on collagen type I/III ratio. CONCLUSION: The present study confirms the importance of a biological approach, next to technical aspects, to the understanding of the pathogenesis of recurrent hernia formation and underscores the presence of a disturbed scarring process. The composition of scar tissue with a lowered collagen type I/III ratio and, therefore, reduced tensile strength may be a major contribution to hernia recurrence.

Cicatrix↗

Prostheses designed for vertebral body replacement.

Prostheses are proposed to restore the spinal stability of patients suffering from metastatic malignant tumours in their vertebral bodies. They are designed to replace only one vertebral body and two neighbouring intervertebral discs of the spine. Experiments performed on cervical, thoracic and lumbar sections, which were obtained from fresh cadavers, have shown that the reduction in average compressive strengths of these regions due to the placement of prostheses is about 9%. This seems acceptable for those patients in performing their daily activities. The same amount of reduction has also been observed in average compressive strengths of the neighbouring healthy vertebrae due to the placement of prosthesis heads by bone cement. Developed prostheses have a number of advantages over the existing fusion constructs for the cases considered in this work.

Biomechanical Phenomena↗

Intranasal prostheses, splints, and stents.

Internal defects of the nose result from congenital abnormalities, trauma, tumor excision, and complications of cosmetic or airway enhancement procedures. Since the nose is a prominent feature of the face, and nasal deformities present complicated reconstructive problems, the rehabilitation of this structure assumes great importance. Surgical and/or prosthetic procedures using intranasal prostheses, splints, or stents have been developed to improve both form and function. Intranasal prostheses, splints, and stents during nasal rehabilitation can (1) establish and maintain airway patency, (2) maintain tissue position, (3) reduce tissue contracture after surgery, or (4) support mobile tissue in the construction and retention of facial prostheses. Although techniques for managing common problems have been presented in this article, unique clinical situations will arise. Much of the execution and ultimate success of nasal prosthetics will depend upon the ingenuity of the dentist performing the service.

Equipment Design↗

Electroactive polymeric sensors in hand prostheses: bending response of an ionic polymer metal composite.

In stark contrast to the inspiring functionality of the natural hand, limitations of current upper limb prostheses stemming from marginal feedback control, challenges of mechanical design, and lack of sensory capacity, are well-established. This paper provides a critical review of current sensory systems and the potential of a selection of electroactive polymers for sensory applications in hand prostheses. Candidate electroactive polymers are reviewed in terms of their relevant advantages and disadvantages, together with their current implementation in related applications. Empirical analysis of one of the most novel electroactive polymers, ionic polymer metal composites (IPMC), was conducted to demonstrate its potential for prosthetic applications. With linear responses within the operating range typical of hand prostheses, bending angles, and bending rates were accurately measured with 4.4+/-2.5 and 4.8+/-3.5% error, respectively, using the IPMC sensors. With these comparable error rates to traditional resistive bend sensors and a wide range of sensitivities and responses, electroactive polymers offer a promising alternative to more traditional sensory approaches. Their potential role in prosthetics is further heightened by their flexible and formable structure, and their ability to act as both sensors and actuators.

Artificial Limbs↗