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Investigation of hip joint prosthesis damage.

Following total hip arthroplasty the durability of a prosthetic implant depends on many factors but is generally limited by two types of damage: wearing of frictional surfaces of the acetabular and femoral component as well as the loosening and migration of the "rosthesis-cement-bone" system. Since it is possible to establish a cause-and-effect relationship between these two damage types, the aim of this research is to investigate the phenomena related to the contact surface and their influence on the prosthesis-bone relationship in general for various sizes and conditions of loading of the hip joint. The experimental study was conducted using a Timken testing device modified in such a way that simulation of relative movements of the joint elements was achieved using a mechanism that produces conditions similar to those in the human hip joint. The analysis of obtained measurements showed that actual radii of friction of the hip prosthesis did not correspond to the theoretical ones and that only a small portion of the total friction surface is realized. Variations of the radius of friction for the examined prosthesis type were very large, which changes the hypotheses on the ability of the prosthetic head and the "prosthesis-cement-bone" system to bear a certain amount of load. The construction and design of prosthetic implant components has a significant influence on both the amount of wear at the site of contact and the loosening of prosthesis.

Arthroplasty, Replacement, Hip↗

[Phonomechanocardiography in the evaluation of the functional status of valvular prosthesis].

The FMCG in 22 patients with valvular prosthesis is analyzed and its clinical, hemodynamic and surgical correlation are established (11 from the I.N.C. and 11 from the Hospital Infantil I.M.A.N.). The average age of the patients was 15 years old, 18 had a mitral and six aortic valvulopathy, and they all required a valvular replacement. Of the mitral prosthesis, 14 were Starr-Edwards (13 of ball valve and one of disc), three Lillehei-Kaster and one Börck-Shiley. In 5 patients, the FMCG suspected disfunction that was later corroborated by catheterism in three patients and by surgery in all of them. The important differences of the FMCG between the group with good and the one with bad function were: the aparition of a rumble, a decrease in the amplitud of the closing snap, index of closing snap opering snap of less than one, lenghtening of fases PFVP and IVCP, and shortening of IVDRP. In the patients with auricular fibrilation, after long dyastoles; that would represent an adequate atrial emptying; the closing snap was more intense, the PFVP was lennthened the IVDRP was shortened when the prosthesis was not properly functioning. All the aortic prosthesis were ball valve Starr-Edwards type; in one the FMCG suspected disfunction and the patient had a sudden death outside of the Hospital. The significant differences of the FMCG were the decrease in the intensity of the opening snap, with a Hylen index of less than one, lengthening of the PFVP, IVCP and of the expulsive period (EP). The authors conclude that the FMCG is a good method for an early detection of the disfunctions of valvular prosthesis.

Adolescent↗

Relief of congenital obstruction to left ventricular outflow with a ventricular-arotic prosthesis.

Hypoplasia of the aortic valve annulus and ascending aorta is a rare form of congenital aortic stenosis, with a poor prognosis. Replacement of the aortic valve and ascending aorta with a suitable prosthesis is feasible, but the hypoplastic valve annulus must also be enlarged if an adult-sized aortic valve is to be placed in the subcornary position. In an effort to develop a new method of surgical treatment for this congenital abnormality, we fabricated a prosthesis which can be interposed between the left ventricular apex and descending thoracic aorta. This prosthesis is coupled to a 25 mm. Dacron graft and xenograft valve and is lined with flocked Dacron fibrils to encourage formation of a stable biologic lining and prevent thrombus buildup. The prosthesis was implanted in a 22 year old male patient of the Children's Hospital Medical Center without difficulty. Postoperative cardiac catheterization idicated that all of the contrast material was ejected from the left ventricle through the prosthesis. The patient was discharged from the hospital taking sodium warfarin and remains entirely asymptomatic.

Adult↗

[Design and study of carbon fiber tracheal prosthesis].

32 healty adult dogs were selected for this experiment. 10 of them were subjected to the tracheal biomechanics test using indices including the relation between stretcher ratio (lambda) and stress (T), the squeeze stress (delta jy) of medical silk thread on trachea, the side stress (Ts) inducing the tracheal collapse, the functional maximum angle (psi max) of tracheal, and the sever area torsion angle (theta max) of tracheal functional maximum curved. According to the indices measured, two types of tracheal prosthesis were designed, and were made of carbon fiber and silicon. They were the straight tube type tracheal prosthesis and the bifurcate type tracheal prosthesis. The straight tube type tracheal prosthesis was studied with a design of two groups comprising a total of 11 dogs. In the experiment group (n = 6), the outer surface of the tube was not coated with silicon, the average survival period was 379.8 days. In the control group (n = 5), the outer surface of the tube was coated with silicon, the average survival period was 90.4 days. The bifurcate type tracheal prosthesis was studied in 11 dogs, the average survival period was 4.32 days. The main causes of death in the experiment were infection and anastomotic dehiscent.

Animals↗

[Treatment of the paraplegic patient with erectile dysfunction by implantation of China-made three-piece inflatable penile prosthesis].

OBJECTIVE: To evaluate the effect of the treatment on paraplegic patients with erectile dysfunction (ED) by implantation of China-made three-piece inflatable penile prosthesis. METHODS: Eighteen paraplegic patients with ED refractory to non-operative treatment were implanted with three-piece inflatable penile prosthesis through an incision at the border of penis and scrotum. The rate of maintained coitus and the satisfactory coitus of spouse were obtained by inquiring and letter visiting. RESULTS: Operations were successfully performed upon all 18 patients. Follow-ups after operations ranged from 3 months to 36 months, mean follow-up being 18 months. Fluid exudation from penile prosthesis and localized infection occurred in one patient and mechanic complication occurred in two. Maintained coitus rate was 17/18. Ejaculation reflection occurred in three patients. CONCLUSIONS: Treatment of paraplegic patient with ED refractory to non-operative treatment by implantation of China-made three-piece inflatable penile prosthesis has good concealment and rehabilitative effect, with similar mechanical troubles to imported products. With excellent covertness, implantation of three-piece inflatable penile prosthesis is well accepted by ED patients.

Adult↗

The use of a closed expandable prosthesis for pediatric sarcomas.

PURPOSE: The purpose of this paper is to review our experience with a non-invasive expandable prosthesis for skeletally immature patients following limb-salvage for malignant tumors about the knee. MATERIALS & METHODS: Between 1998 and 2002, Repiphysis prostheses (Wright Medical Technology, Memphis, Tenn.) were implanted in 18 patients. 16 patients had at least 12 months follow-up. There were 10 males and 8 females. The diagnosis was Stage IIB osteosarcoma in all patients. Sites included femur 14, and 4 proximal tibias. The average age was 10.7 years (range 8-16); the average age for males was 12 years and females, 9 years. Fifteen of the prostheses were implanted at the time of surgical resection and the remainder was conversions of previous surgery. RESULTS: Follow-up averaged 24.8 months (range 12-47). Fourteen patients have undergone a total of 58 lengthening procedures. Average expansion 38 mm per patient (range, 10-76 mm). An average of 8.5 mm per lengthening procedure. There was only one failure to lengthen. ISOLS functional scores averaged 83.5%. For those with a current functional prosthesis, the ISOLS score averaged 94%. Three patients have reached maximal expansion and converted to a conventional prosthesis. There were complications in 7 patients: 2 expandable component fractures, 1 femoral component fracture, 2 stem fractures, 1 stem loosening and 1 deep infection. Of the two expandable component fractures, 1 patient reached full expansion and was converted to an endoprosthesis. The femoral component fracture and 2 stem fractures were revised to a new prosthesis 13 months post-op and are functioning well. The 1 loose stem was revised to an APC. CONCLUSIONS: The Repiphysis prosthesis utilizes energy stored in a spring that is held compressed by a locking mechanism. Controlled release of the locking mechanism via an external electromagnetic field allows for lengthening of the device. In our early experience, the functional results were excellent similar to conventional modular devices. Complications should be anticipated but are salvageable. This device allows limb salvage in pediatric patients when amputation would be otherwise chosen.

Adolescent↗

Low IGF-I in synovial fluid and serum in patients with aseptic prosthesis loosening.

BACKGROUND: We have previously shown that proliferation in primary cultures of human osteoblast-like cells is lower after exposure to synovial fluid from patients with aseptic prosthesis loosening than after exposure to synovial fluid from patients with osteoarthrosis. MATERIALS AND METHODS: Insulin-like growth factors (IGF) I and II and IGF binding proteins (IGFBP) 3-6, were measured with radioimmunoassy in synovial fluid and in serum from patients with aseptic prosthesis loosening or osteoarthrosis. Proliferation in osteoblast-like MG-63 cells was studied with the CyQUANT assay. RESULTS: IGF-I and IGFBP-4 concentrations were lower whereas the concentration of IGFBP-6 was higher in synovial fluids from patients with prosthesis loosening than in synovial fluid from patients with osteoarthrosis. IGF-I concentrations in serum from patients with prosthesis loosening were also lower than in the osteoarthrosis group, and were even below the normal range in most cases (72%). Synovial fluid from patients with aseptic loosening had a weaker stimulatory effect on MG63 osteoblast-like cell proliferation than synovial fluid from patients with osteoarthrosis, but there was no difference between the two groups when a human IGF-I antibody was added. INTERPRETATION: Low levels of IGF-I in synovial fluid possibly result from low serum levels and may be a mechanism leading to aseptic prosthesis loosening.

Aged↗

[Reoperation after limb salvage surgery with prosthesis for bone tumor].

OBJECTIVE: To analyze the causes and the reoperation therapies after salvage limb surgery with prosthesis for bone tumors. METHODS: The retrospective analysis was performed on 85 patients undergoing the limb salvage operation with prosthetic replacement for tumors from January 1994 to December 2004. Of the patients, 21 (13 males and 8 females, aged 18-58 years) underwent reoperations for various reasons. All the diagnoses were pathologically confirmed (10 patients with osteosarcoma, 4 with chondrosarcoma, 5 with giant cell tumor of the bone, 2 with osteofibrosarcoma). The distal femur was involved in 9 patients, proximal tibia in 8, proximal femur in 2, proximal humerus in 1, and acetabulum in 1. According to the Enneking surgical grading system, there were 5 patients in I B and 16 in II B. The time between the first operation and the reoperation was 2 weeks to 20 years. The common reasons for the reoperation were tumor recurrence in 8 patients, prosthetic loosening in 5, no healing of the incision in 4, joint dislocation in 3, and implant fracture in 1. The amputation and the prosthesis revision were respectively performed on 6 patients, extensive resection of the tumor on 3, the myo-skin flap translocation on 4, internal hemipelvectomy without reconstruction on 1, and open reduction on 1. RESULTS: The follow-up in 18 patients for 1-5 years (average, 3 years and 4 months) revealed that 4 patients died of osteosarcoma with pulmonary metastasis. The other 14 patients had no tumor recurrence or loosening of the prosthesis, and the incisions healed well. The assessment on the joint function was performed on 13 of the 18 patients and the results were as follows: excellent in 2 patients, good in 5, fair in 4, and poor in 2, with a satisfaction rate of the reoperation with limb salvage of 84.6% and an excellent-good rate of 53.8%. CONCLUSION: Tumor recurrence is the most common reason for the reoperation after the limb salvage with prosthesis for tumors, and loosening of the prosthesis is an important reason, too. By the rules of the bone tumor limb savage, the limb salvage operations can also be performed, which can achieve a satisfactory result of the limb function.

Adolescent↗

[Clinical outcomes of treatment of glenohumeral osteoarthritis with new generation shoulder prosthesis].

OBJECTIVE: To investigate the clinical effects of arthroplasty with UNIVERS 3-D prosthesis, the representative of fourth generation of shoulder joint prosthesis proved to be more suitable to shoulder anatomy, in treatment of glenohumeral osteoarthritis. METHODS: Seventy-four patients with glenohumeral osteoarthritis, aged 67.07 (47 - 84), received shoulder arthroplasty with UNIVERS 3-D prosthesis and were followed up for 31.9 months (12 - 74 months). Roentgenography was conducted to observe the acromion, and acromion-humeral distance (AHD), glenohumeral distance (GHD), humerus height (HH), and humerus width (HW). Constant scoring and normalized Constant scoring were used to evaluate the function of the shoulder joint. RESULTS: The Constant score at the last follow-up was 68.40 +/- 16.91 points, significantly higher than that at beginning (34.094 +/- 15.00, P < 0.05), The normalized Constant score at the last follow-up was 92.27 +/- 22.53%, significantly higher than that at the beginning (45.29 +/- 19.87%, P < 0.05). The post-operative pain, daily life, activity score, and myodynamia scores were all significantly higher than those evaluated pre-operatively (all P < 0.05). Pre-operative roentgenography showed 93.47% of the cases with humeral head periarticular osteophytes located at the inferior side; 36.96% with humeral head necrosis; 8.69% with humeral head cyst; and 39.13% with periarticular osteophytes of glenoid, and showed that AHD was shortened (1.83 +/- 1.64 mm), and GHD, HH, and HW were all narrowed (10.91 +/- 3.03 mm; 5.71 +/- 4.32 mm, and 3.34 +/- 4.82 mm respectively). After the operation, the AHD, GHD, and HH were all significantly increased, and HW did not significantly changed. The humeral inclination angle was changed postoperatively from 126 degrees to 142 degrees. The incidence of radiolucent lines around the prosthesis of humeral shaft was 5.41%, most in the zones d, c, and e, all with the radiolucent index of less than 1. The overall complication rate was 12.2%. CONCLUSION: Treatment of glenohumeral osteoarthritis with UNIVERS 3-D prosthesis effectively reconstructs the anatomy of glenohumeral joint, and shows excellent clinical results with low incidence of radiolucency and postoperative complications.

Aged↗

[Teflon mandril method for pre-clotting a highly porous small-caliber fabric prosthesis].

Healing characteristics in a highly porous fabric prosthesis are better than in a porous low one. However, bleeding from the highly porous graft wall after implantation has been a very big problem for surgeons, preventing them from using this prosthesis. When a small-caliber graft is pre-clotted and implanted, the condition of the inner surface, such as smoothness, enhances patency and anti-thrombogenicity. We developed a method for pre-clotting a highly porous small-caliber fabric prosthesis using Teflon Mandril. Before pre-clotting, a fabric vascular prosthesis was held end-to-end and stretched to make the crimp shallow. Teflon stick, which outer diameter was 0.5 mm smaller than the graft, was used to pre-clot. Fresh blood was poured into the space between the stick and the vascular graft. After 3 to 5 minutes, when the blood coagulated, the vascular graft with the stick inside was squeezed with a dry towel. Care was taken not to peel the fibrin attached to the graft. With this method, a smooth and tight fibrin meshwork was obtained at the inner surface. This procedure was repeated five times. As a control, pre-clotting was induced according to Yate's method using the same fabric prosthesis. Two groups of pre-clotted grafts were examined macroscopically and in a perfusion model. Macroscopically, the inside of the graft in the developed method was smooth and without thrombus. On the other hand, in the control grafts, the fibrin meshwork was observed and thrombus at the crimp was noticed.(ABSTRACT TRUNCATED AT 250 WORDS)

Animals↗

[Björk-Shiley-Monostrut prosthesis of the aortic valve. Mid-term development].

From July 84 to June 88, 100 patients underwent an isolated aortic valve replacement by a Monostrut-Björk-Shiley prosthesis. Fifty-one had calcified aortic stenosis, 24% aortic insufficiency, 25% mixed aortic lesions. Pre-operatively, their mean age was 57 years, 68% were male, 46% were in NYHA class II or IV, 43% had angina, all were in sinus rhythm. Operative mortality was 4%. All the survivors were followed-up for a mean period of 22 months (6 to 58) with a cumulative follow-up of 183 patients-years. All patients were placed on a long-term regimen of anticoagulant therapy. Two late deaths occurred (1 myocardial infarction, 1 cerebral hemorrhage). The 4 years survival rate was 94%. Postoperative functional results were excellent. Nearly all patients were asymptomatic. Concerning valve related complications: the 4 years actuarial rate of patients free from thromboembolism, hemorrhage, valve thrombosis, periprosthetic leakage and endocarditis were respectively 97%, 97%, 100%, 100% and 100%. No patient were reoperated on. Valvular function was evaluated by mean transprothetic gradient on echo-doppler (61 cases) and by the calculation of the valvular area with transseptal catheterization (21 cases). For small sizes prosthesis (annulus diameter of 19 or 21 mm), medium size prosthesis (23 or 25 mm), large size prosthesis (27 to 29 mm), mean transprothetic gradient were respectively 16, 10 and 6.9 mmHg and valvular aortic area were respectively 1.5, 1.9 and 2.4 cm2. Mid term results of the Monostrut-Björk-Shiley prosthesis on aortic position are good with a low rate of valve related complications and good hemodynamic results, even with the small valve size.

Actuarial Analysis↗

[Post-operative evaluation of a 17 mm diameter Björk-Shiley Monostrut prosthesis for aortic valve replacement--pressure gradient and effective valve area].

A 17 mm diameter Björk-Shiley Monostrut prosthesis was implanted in a 64-year-old female for aortic valve replacement in a semi-emergency. This valve was one of the smallest valves which were available in Japan. The patient was admitted because of severe hemolytic anemia and heart failure. Echocardiography showed regurgitation and calcification of Ionescu-Shiley tissue valve which was implanted 5 years ago. The patient's body surface area was 1.2 m2. Because of narrow aortic annulus, we could barely implant a 17 mm diameter Björk-Shiley Monostrut prosthesis. The valve function was examined by Brockenbrough method. During catheterization, the heart rate was 85 b/min and cardiac index was 3.00 l/min/m2. In these hemodynamic conditions, simultaneous measurements of aortic and left ventricular pressures revealed only 9 mmHg mean systolic pressure gradient. Similarly, 20 mmHg of pressure gradient across the implanted valve was obtained by Gorlin's formula. We could calculate that the effective orifice area of a 17 mm diameter Björk-Shiley Monostrut prosthesis was 1.0 cm2. Postoperative echocardiography demonstrated 42 mmHg systolic pressure gradient across this prosthesis by Doppler techniques, and left ventricular wall thickness was not decreased. To best our knowledges, this was the first case in which post-operative evaluation such a small prosthesis was measured.

Aortic Valve↗

[Long-term results of isolated aortic valve replacement using a Bjork-Shiley prosthesis. A clinical study of a series of 365 patients with a postoperative follow-up of 8 to 16 years].

365 patients (mean age: 59 years) surviving isolated aortic valve replacement performed between 1971 and 1978 by means of a standard flat disk Bjork-Shiley prosthesis, underwent regular and complete follow-up (100% survival rate) representing 3,248 patient-years with a maximum follow-up of 15.4 years (mean: 8.9 years). All of these patients received anticoagulant treatment, which was considered to be well-controlled in 90.5% of cases. 121 secondary deaths (33.1%) were observed. Cardiac causes were the most frequent (35/121, i.e., 28.9%). Four deaths were directly related to the prosthesis (2 infections, 1 thrombosis, 1 dysfunction). Twenty deaths (16.5%) were related to cerebral vascular accidents and 2 (1.6%) to haemorrhagic complications. In 24 cases, the cause of death could not be determined (19.8%). Overall, 1 out of 5 deaths (21.4%) was directly or indirectly related to the prosthesis. The actuarial survival rate was 85.5% at 5 years and 67.9% at 10 years. Seventeen thromboembolic complications (7 lethal, 10 non-lethal) were observed and represented a linear incidence of 0.5% per patient-year. Fourty-one haemorrhagic complications were observed in 28 patients, i.e. a linear incidence of 1.26% per patient-year. Nine reoperations were necessary, responsible for 3 deaths. No cases of mechanical failure of the prosthesis were observed. All of the lethal and non lethal complications related to the prosthesis represented a linear incidence of 2.6% per patient-year. AT 5 and 10 years after the operation, 89.2% and 79.6% of the patients were free of any valve-related complications. The functional results was considered to be good or excellent in the very great majority of surviving patients (97.8%).(ABSTRACT TRUNCATED AT 250 WORDS)

Actuarial Analysis↗

[The biosynthetic Omniflow prosthesis: preliminary experience].

The Omniflow biosynthetic prosthesis is made by a polyester net set on a silicon mandrel and planted on the sheep's back in order to from a tube of collagen that is fixed by glutaraldehyde at the moment of removing. This idea comes from the experience made in using glutaraldehyde as biologic fixative employed for the first time in the fixation of the cardiac valves by Carpentier in 1976 and in using nets of synthetic material set on a mandrel in man by Sparks in 1986, to form a tube of collagen to be used as a vascular prosthesis. Such a prosthesis has the advantage of the natural collagen deprived of its immunogenicity and also the increased resistance due to the polyester net. The authors report their experience in three arteriopathic patients employing Omniflow prosthesis used for the manufacturing of femoropopliteal bypass, a femoro-femoral bypass and for the substitution of an infected branch of axillobifemoral bypass. They describe the handling and the technique for the right application to avoid immediate complications, among which the most dangerous is the acute obstruction. Then they discuss the results which are encouraging even if the fellow up is too short. For such a reason they report the casuistic with long distance results obtained by the use of the same prosthesis by Raithel et Al., one of the largest experience in literature.

Aged↗

Arthroplasty of the temporomandibular joint with use of a vitallium condyle prosthesis: report of three cases.

We have devised a Vitallium intramedullary prosthesis to replace the deformed arthritic condyle in cases that require bilateral condylectomy or in rare long-term failures of a single condylectomy. Experience has led to modification of this prosthesis. Recently a rectangular stem that prevents rotation of the prosthesis in the condylar stub has been added (Fig 11). In bilateral condylectomies, replacement of only one side by the Vitallium condylar prosthesis is adequate, because it stabilizes the mandible by maintaining its original fulcrum in the temporomandibular joint. Three cases of replacement with the Vitallium condyle prosthesis are reported, with follow-up studies of two to three years postoperatively. The results to date have been gratifying.

Adult↗

Metastatic diaphyseal fractures of the shaft of the humerus. The structural strength evaluation of a new method of treatment with a segmental defect prosthesis.

The surgical treatment of extensive metastatic diaphyseal lesions of the humerus with pathologic fractures is difficult. Patients with failed internal fixation often have large segments of bone loss. Rigid fixation often is not possible in these cases. Four patients were treated with a titanium segmental defect (SD) prosthesis with good clinical results. A comparative in vitro analysis of fixation with the SD prosthesis, a Rush rod, and a dynamic compression plate (DCP) augmented with methylmethacrylate was performed. The SD prosthesis performed better than the Rush rod and DCP in both the nondestructive four-point bending test and the destructive torsional test. The reconstructed humeri using the SD prosthesis had a torsional strength approaching that of an intact specimen. Hence, the SD prosthesis is a useful adjunct device in treating patients with extensive destructive lesions of the humerus secondary to metastatic disease and hematologic malignancies and in patients with malignant diseases who have had failed attempts at internal fixation.

Adult↗

Tracheal reconstruction with hydroxyapatite tracheal prosthesis.

A porous hydroxyapatite tracheal prosthesis was implanted in rabbits after resection of a 15 mm circular segment of the cervical trachea. Postoperatively the animals were followed by radiography, bronchoscopy, and microscopy at the time of autopsy. The longest survival time was 22 weeks. All the rabbits died of infection at the prosthetic site or of progressive stenosis at the anastomoses. The prosthesis was incorporated by surrounding tissues, but no overgrowth of ciliated epithelium on the luminal surface of the prosthesis was observed. Although a hydroxyapatite tracheal prosthesis is tolerated in rabbits, covering of the luminal surface of the prosthesis with a non-porous layer to prevent infection and to permit mucosal overgrowth is necessary to achieve better long-term results.

Animals↗

Biomechanical evaluation of an adjustable patellar tendon bearing prosthesis.

The purpose of this study was to determine the relation between geometry of the patellar tendon (PT) insertion in the socket and the dynamic load transmitted through the PT, in a patellar tendon bearing (PTB) prosthesis. The dynamic load was measured by a specially constructed two-component load cell, which was mounted on the experimental prosthesis. Geometry of the PT insertion relative to the socket was altered by adjusting the location of the mounting frame-load cell assembly. Evaluation of performance of the prosthesis in the range of geometries investigated was made objectively by gait analysis of the patients. The latter was performed on a 10 m walkpath, including at halfway two forceplates, from which the foot-ground forces were recorded. Simultaneously, the PT forces on the prosthesis, as sensed by the load cell were monitored. Computer processing of the data included full analysis of the force-trace and the determination of criteria for optimization of the PT insertion. The resulting criteria were those which expressed minimization of abnormalities in the foot-ground forces of each patient, such as vertical and braking forces and their timings. The complete optimization procedure, which was undertaken for two below-knee male amputees, indicated the correct positioning of the PT insertion, actually taken in the final fitting procedure of the socket of the prosthesis.

Adolescent↗