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Porous-type tracheal prosthesis sealed with collagen sponge.

BACKGROUND: Reconstruction of a long section of the trachea is clinically problematic. Tracheal reconstructions using prostheses have met with limited success due to local infection, hemorrhage, luminal stenosis and prosthesis dislocation. METHODS: We have designed a porous type of tracheal prosthesis in which the mesh is sealed with collagen sponge. We used this prosthesis (50 mm in length) to reconstruct the cervical trachea in 10 mongrel dogs and evaluated its efficacy. RESULTS: One dog died due to an accident with anesthesia at 6 weeks and 1 of suffocation at 10 weeks. The other 8 dogs had an uneventful postoperative course until they were killed between 6 and 24 months after implantation. At sacrifice, all the prostheses had become completely incorporated into the host. Microscopic examination revealed advanced formation of a new epithelial lining in 1 dog at 6 months, and a confluent epithelial lining was observed in another dog at 12 months. Central stenosis was not significant in any of the animals. CONCLUSIONS: This tracheal prosthesis gives good results in canine tracheal reconstruction, and appears very promising for the clinical repair of tracheal defects.

Animals↗

Ocular prosthetics: use of a tissue conditioner material to modify a stock ocular prosthesis.

The custom-made ocular prosthesis contributes to enhanced tissue health of the anophthalmic socket. For this purpose, an acrylic resin ocular prosthesis may be modified, by using an appropriate dental impression material and being adapted closely to the anophthalmic socket. The modeling impression material is subsequently replaced by acrylic resin. This article describes the application of a viscoelastic tissue conditioner material, as an impression medium for prosthetic modification of an ocular prosthesis. The tissue conditioner material exhibits favorable tissue compatibility, adhesion to acrylic resin, and detailed surface registration. These advantages facilitate the clinical procedure and evaluation of modifications made to the ocular prosthesis.

Acrylic Resins↗

Management of severe corporeal fibrosis with implantation of prosthesis via a transverse scrotal approach.

PURPOSE: We reviewed our experience in the management of severe corporeal fibrosis with placement of the AMS 700 CXM* prosthesis to determine the efficacy of this approach. MATERIALS AND METHODS: The records of 26 men with severe corporeal fibrosis who underwent placement of the AMS 700 CXM prosthesis via a transverse scrotal approach between August 1991 and July 1996 were reviewed. RESULTS: In all cases the AMS 700 CXM prosthesis was successfully implanted with primary closure of the tunica albuginea, although 2 patients required extended corporotomies. Followup data were available on all 26 men. At a mean followup of 22.5 months (range 3 to 63) 24 of the 26 men had a functional device (92%). One patient required explantation for infection and 1 underwent explantation for cylinder cross-over. CONCLUSIONS: Implantation of the AMS 700 CXM prosthesis in patients with severe corporeal fibrosis produced good results at approximately 2 years of followup.

Adult↗

Multicenter trial in North America of UroLume urinary sphincter prosthesis.

We investigated the effectiveness and associated complications of treatment with an endoluminal urethral sphincter prosthesis in 153 spinal cord injury men (mean age 36 years, range 16 to 74 years) with urodynamically diagnosed detrusor-external sphincter dyssynergia. These patients were prospectively treated with a urethral sphincter stent at 15 centers in North America. Followup ranged from 2 to 33 months. Voiding pressures averaged 76 +/- 28, 42 +/- 21, 44 +/- 38, 35 +/- 18 and 32 +/- 20 cm. water, respectively, before prosthesis insertion in 153 patients and at 3 months in 123, 6 months in 114, 12 months in 98 and 24 months in 22. A significant decrease in voiding pressure was noted in the 22 patients at 24 months compared with matched preoperative data (80 +/- 25 cm. water, p = 0.03). The residual urine decreased from 181 +/- 154 ml. before insertion to 82 +/- 93 ml. at 24 months (p = 0.01). Maximum cystometric capacity remained constant, with a mean of 195 +/- 158 ml. before insertion to 248 +/- 122 ml. at 24 months (p = 0.17). No significant differences were apparent after 24 months of followup in any of the urodynamic parameters between 44 patients with and 109 without previous external sphincterotomy. Hemorrhage requiring blood transfusion, obstructive hyperplastic epithelial overgrowth and soft tissue erosion did not occur. No deleterious effects were observed on renal or erectile function. Of the patients 43 (28.1%) required 2 prostheses to bridge the external sphincter completely. Stent removal was required in 10 patients. Seven explantations were required for prosthesis migration, 1 for pain and urethral edema, 1 for inability to maintain a condom catheter, and 1 for nonepithelialization and secondary bladder neck obstruction. A total of 13 patients (8.5%) required a subsequent operation for bladder neck obstruction. Therefore, the sphincter prosthesis is an attractive modality for the treatment of external sphincter dyssynergia in patients with and without previous external sphincterotomy because of its ease of deployment and minimal associated morbidity.

Adolescent↗

Experience with the Hydroflex penile prosthesis.

Between July 1985 and September 1987 we implanted 51 Hydroflex* penile prostheses for treatment of erectile impotence, with a minimum followup of 6 months in all patients and more than 1 year in 43. There have been no mechanical failures and no major complications. Of 47 evaluable patients 38 (81 per cent) are satisfied with the prosthesis. The 9 dissatisfied patients include 3 men who still are experiencing some difficulty operating the pump mechanism and 6 who desired a fuller or stiffer erection than provided by the Hydroflex prosthesis. All of the latter 6 individuals have successfully engaged in intercourse with the Hydroflex device. The patient who previously received a Scott inflatable penile prosthesis may not be as content with the erect state of the Hydroflex device. It also is important to assure adequate distal corporeal length before placement of the Hydroflex prosthesis.

Consumer Behavior↗

Penile prosthesis reimplantation.

Occasionally, penile prostheses are removed following erosion, infection or malfunction and they are not replaced immediately. Patients may present later for reimplantation of a penile prosthesis after an interval free of a device. However, no information is available as to the outcome and difficulties of such a procedure. We reviewed the charts of all 305 patients undergoing implantation of a penile prosthesis at our institution and contacted all 8 who had undergone reimplantation. Bilateral prostheses were placed in 4 patients. Unilateral prostheses only could not be implanted in either side because of extensive fibrosis. Of the 8 patients 4 are able to have intercourse (1 with difficulty) and reimplantation of the prosthesis often was difficult or impossible. We conclude that reimplantation of a penile prosthesis is beneficial for some patients but they should be informed of the possibility of unsatisfactory results.

Adult↗

A bladder-neck support prosthesis for women with stress and mixed incontinence.

OBJECTIVE: To evaluate the safety and efficacy of a bladder-neck support prosthesis, a vaginal device designed to support the bladder neck, in women with genuine stress and mixed incontinence. METHODS: For enrollment, incontinent women underwent a history, physical examination including cotton-swab test, urinalysis, postvoid residual urine, and multichannel urodynamic testing. Those with genuine stress incontinence or mixed incontinence and urethral hypermobility completed 7-day bladder diaries, the Incontinence Impact Questionnaire, and underwent standardized pad tests. They were fitted with a prosthesis and seen weekly to optimize fit and efficacy. At week 5, they underwent repeat evaluations with the best-fitting prosthesis in place. RESULTS: Seventy women were enrolled and 53 completed the 1-month study (29 genuine stress incontinence, 24 mixed incontinence). The mean ages were 50.4 years for genuine stress incontinence (range 24-76) and 55.7 years for mixed incontinence (range 30-88). A statistically significant reduction in incontinence was noted on pad testing (genuine stress incontinence, mean 46.6-16.6 g; mixed incontinence, mean 31.9-6.8 g) and in the bladder diary (genuine stress incontinence, mean 28.6-7.8 losses per week; mixed incontinence, mean 30.2-15 losses per week). Quality-of-life scores improved in both groups. With the device in place, urodynamic testing indicated normalization of urethral function without evidence of outflow obstruction. Subjects found the device comfortable, easy to use, and convenient. Side effects included five urinary tract infections and 23 cases of vaginal mucosal soreness or mild irritation. CONCLUSION: The bladder-neck support prosthesis significantly reduced involuntary urine loss in women with stress and mixed incontinence.

Adult↗

[Ankle arthrodesis after failure of a total ankle prosthesis. Eight cases].

UNLABELLED: We report outcome in eight cases of ankle arthrodesis after failure of a total ankle prosthesis. MATERIAL AND METHODS: This series included eight patients, mean age 57 years (range 36-76) who had initially: post-traumatic talocrural joint degeneration (n=4), rheumatoid polyarthritis (n=3), idiopathic talocrural degeneration (n=1). Three patients had a New Jersey (DePuy) cemented prosthesis, four had a Star (Link) uncemented prosthesis and one, whose implantation was performed in another institution, had a spherical cemented prosthesis. The preoperative Kitaoka score was 19.1 (0-32). Seven patients had subtalar joint degeneration; one patient had a subtalar arthrodesis. The tibial component was cemented alone in two patients, the talar piece in three (two with talar fracture). Failure resulted from loosening, talus fracture or deep infection. Bipolar loosening was observed in two patients. Time to revision was 36 months (range 4-108). Arthrodesis was associated with an iliac graft for seven patients: several tricortical grafts (vertical alignment of the corticals) and cancelous grafts for filling. The height of the graft was adjusted to the substance loss. A bone graft could not be used in one patient who had a deep infection. The arthrodesis was fixed with an anterior plate bridging the talocrural space in six patients, with an external fixator in infected patient, with a conventional centromedullary tibial nail transfixing the talocrural joint and planted in the talus and the calcaneus in one. Outcome was assessed with the Kitaoka score. Mean follow-up was 56 Months (range 10-114). RESULTS: The overall Kitaoka score improved to 54/100 (range 42-70) at last follow-up. The arthrodesis provided improvement in all patients although the final outcome was still considered poor in three patients. Radiographic healing was obtained in seven patients at a mean 3.1 months (range 2.5-6). Wound healing was slow in two patients. One patient developed a deep infection early. DISCUSSION: The rate of fusion was 87%. This is in the general range reported in the literature; use of an iliac graft allows preserving joint height but because of the poor bone quality often encountered, residual bone stock may be insufficient to achieve complete fixation with screwing. Plate fixation appears to be a better way of achieving fixation. This provides a rate of fusion comparable with earlier series where external fixation was generally employed. For us, external fixation should be reserved for infected cases. Use of a conventional anterograde nail can be another solution in the event of poor bone quality. The overall result remains relatively modest although all the patients achieved a functional gain with arthrodesis. The results obtained are less satisfactory than after first-intention ankle arthrodesis.

Activities of Daily Living↗

Functional anatomical reconstruction in an oculofacial prosthesis.

The exenterated, maxillectomy, and/or palatectomy patient is ideally referred prior to surgery for two primary reasons: (1) to reassure the patient of an attempt to restore appearance and function to nearly the same as before ablative surgery, and (2) to make an entire face alginate impression for post surgical replication. The sixth week postoperatively, a second full-face alginate impression is made of existing wound and remaining anatomy. Photographs are taken for comparative sculpting. The prosthesis is designed to redirect airflow to a normal pattern in order to avoid "blow out" of the prosthesis from a sneeze or cough. Bone-like acrylic sinus replication provides normal speech resonance, a bonding surface for Silastic "skin" and a hollow socket for an impression-fitted prosthetic eye. The prosthetic eye, intrinsic pigmentation and extrinsic pigmentation, eye lashes and brows are incorporated into completed prosthesis. A combination of aesthetic and functional elements into a single three- or four-piece prosthesis provides restoration of natural appearance, improved functions of facial anatomy, and improved breathing, sinus drainage, speech articulation and resonance.

Eye, Artificial↗

The influence of inserting a Fuji pressure sensitive film between the tibiofemoral joint of knee prosthesis on actual contact characteristics.

OBJECTIVE: To investigate the influence of inserting a Fuji pressure sensitive film between the tibiofemoral joint of knee prosthesis on actual contact characteristics. DESIGN: A finite element analysis was used to investigate the alteration of contact characteristics of the tibiofemoral joint due to inserting a pressure sensitive film between the contacting surfaces. BACKGROUND: The discrepancy between actual contact behaviors of tibiofemoral joint of knee prosthesis and the measurement using Fuji pressure sensitive film was not discussed extensively. The change of direct contact circumstance of the tibiofemoral joint due to inserting a pressure sensitive film was not well reported. METHOD: A two-dimensional finite element model of the tibiofemoral joint of knee prosthesis in the sagittal plane was constructed. Four different radii of the femoral component were used to investigate the conformity effect. Two-layers of plane strain element were used to model the pressure sensitive film. The influence of inserting a pressure sensitive film on the actual contact characteristics was analyzed by comparing the results of the change in contact radius. RESULTS: Inserting a pressure sensitive film between contacting surfaces would disturb the original contact behaviors, especially in the lowest conformity design. The maximum difference of contact radius between the model simulating actual contact circumstance and the model with inserting a pressure sensitive film between contacting surface was 77% in the lowest conformity condition at the smallest load. CONCLUSIONS: This study proposes a quantitative analysis of contact characteristics in the tibiofemoral joint of knee prosthesis between the models with and without inserting a pressure sensitive film into the contact surface. The measurement of contact area in artificial tibiofemoral joints by using Fuji pressure sensitive film is always overestimated its true contact area by 14-77%. RELEVANCE: This study revealed the measurement of contact characteristics of artificial tibiofemoral joints by using Fuji pressure sensitive film which depends on not only the applied load, but also the conformity and material properties of the contact surface. Therefore, the information of the conformity and material properties of the contact surface should be provided as well as the applied load wherever a measurement of contact characteristics using Fuji pressure sensitive film is analyzed and interpreted.

Biomechanical Phenomena↗

Primary reconstruction of the mandible with a wire mesh prosthesis.

A stainless steel wire mesh prosthesis was used as a primary mandibular replacement in 102 patients following resection of malignant neoplasms arising in the head and neck. In 67 patients the prosthesis was considered successful. Failure of the host to tolerate the prostheses was associated with history of previous irradiation, extensive resections, and the loss of distant skin flaps used for coverage of the prosthesis. But the prosthesis is tolerated by the host in 90% of the cases if it is inserted in a non-irradiated bed, covered with local tissues, and the resection is limited to the maxillo-oral complex only.

Follow-Up Studies↗

Amputation and prosthesis.

Amputation of a limb is a drastic therapy in cattle and should be considered as a last resort in the treatment of limb injuries. Even though the surgical technique for amputation is simple, daily limb management, prosthesis manufacture, and adaptation of the animal to the prosthesis are difficult and time consuming. Dedication of the owner to the aftercare required for the rest of the animal's life is extremely important. Amputation of a limb with prosthesis application is a method of saving valuable animals for breeding purposes or animals of sentimental value. The author reviews his experience with partial foreleg amputation and prosthesis application in three heifers.

Amputation, Surgical↗

Analysis of two bone-prosthesis interfaces and membranes from non-cemented trapeziometacarpal prostheses.

The non-cemented Ledoux trapeziometacarpal prosthesis has a high failure rate. In order to better understand the mechanism responsible for pain and loosening, we thoroughly analysed the membranes surrounding the prosthesis and the bone-prosthesis interface in two trapezia, each containing a Ledoux cup, which were resected after unsuccessful implantation. Serial sections, perpendicular to the longitudinal axis of the implanted cup, allowed histological examination of the interface and were used to quantify bone apposition. The tissues surrounding the prosthesis showed a foreign-body reaction to particles identified as titanium. The interface showed bony integration of the cup, mainly on the radial side and on the proximal part of the cup, with an appositional index of 28%. Our findings suggest that bony apposition might not be sufficient to ensure successful anchoring of the Ledoux cup in the trapezium in the presence of an intense foreign body reaction to titanium. Moreover, the presence of metal might be secondary to micromotion of the wings of the metallic part of the cup, induced by axial movement of the underlying polyethylene during pinch grip. The combination of polyethylene as an expander and titanium may need to be reviewed.

Humans↗

Fifteen years experience of penile prosthesis insertion.

INTRODUCTION AND OBJECTIVES: To review the outcome and patient satisfaction of penile prosthesis insertion over a 15 y period. PATIENTS/MATERIALS AND METHODS: We reviewed the notes of 172 patients who underwent penile prosthesis insertion between January 1980 and May 1995. From the notes information was determined on age of the patient, type of prosthesis, surgical approach and length of stay. Also noted were risk factors for erectile dysfunction and the aetiology. Twenty patients were known to have died or moved away. To assess the impact the operation had on quality of life, 152 questionnaires were sent of which 103 were returned (67%). The questionnaire gained information about sexual activity, before and after the operation and the overall satisfaction of the patient and his partner and whether they felt the operation was a success. RESULTS: Overall 149 patients were known to have had malleable prostheses inserted and 23 had inflatables. The commonest organic groups were vascular disease, diabetes and Peyronies disease. Fifteen patients had two procedures. Four patients required revision of the prosthesis due to erosion, and there was one death due to pulmonary embolism. One hundred and three completed questionnaires have been returned to date the median time since operation was 4 y, the range being six months to 16 y and 78% thought the operation was a success. CONCLUSIONS: The insertion of malleable prostheses is associated with low complication rates, good patient satisfaction and improved quality of life for the couple. Concealment was not a major problem.

Adult↗

Prosthesis culture 6 months after implantation and the effect of haematogenous seeding in a rat model.

The aim of this study was to investigate the role of haematogenous seeding in late prosthesis infection. In all, 45 male Wistar albino rats were divided into three equal groups. A small piece of silicone prosthesis was implanted into the scrotum of all rats under sterile condition and antibiotic prophylaxis. In the first group, all silicones were removed after 6 months without any complication and were cultured for bacterial growth. In the second group, a disc, which was saturated with Staphylococcus epidermidis, was inoculated subcutaneously in the legs of the rats in the 6th month, revealing a nodule formation 4-5 days after the inoculation and treated with an appropriate antibiotic after the nodule formation. In the third group, the same disc was inoculated, but all rats were treated immediately from the inoculation time onwards. The silicones of the second and third group were also removed at the end of the 6th month and were cultured to observe the bacterial growth. There was no evidence of prosthesis infection in any of the three groups. In the first group, three cultures were positive and revealed approximately 10 000 colonies of S. epidermidis in two and Proteus mirabilis in the remaining. Three and four cultures were positive in the second and third group, respectively. Low colonies of four different organisms (Escherichia coli, S. aureus, S. epidermidis, Pseudomonas aeruginosa) were identified in these cultures. There was no statistical significance of positive cultures in the three groups. Based on our results, there does not appear to be a true significance of haematogenous seeding on late prosthesis infection.

Animals↗

Satisfaction with the malleable penile prosthesis among couples from the Middle East--is it different from that reported elsewhere?

No studies from the Middle East have investigated the psychosexual aspects of penile prosthesis. Therefore, several questions were used herein to address satisfaction with the use of malleable penile prosthesis among couples from this geographic area, as an option to treat erectile dysfunction (ED). A total of 50 patients who underwent the insertion of AMS 650 and Acu-form penile prostheses and their partners were evaluated with a retrospective clinical record review, as well as patient and partner questionnaires. In all, 70% of the patients and 57% of the partners were satisfied with the prosthesis. There was an increase in frequency of intercourse, sexual desire, and ability to achieve orgasm. Dislike for the device was the most common cause for nonsatisfaction of patients with the device, while sense of unnaturalness was that for partners. Results from this evaluation highlight the obvious need for proper preoperative counseling for both the patient and his partner to minimize unrealistic expectations. They also emphasize the importance of careful screening of both psychosocial and psychosexual aspects of the couple based on cultural ethnic background, since these are important predictors of the therapeutic outcome of prosthesis insertion. Efforts to extend information about ED to the public may be useful to reduce patients' exaggerated embarrassment about this problem and make their partners actively involved in the treatment.

Adolescent↗

Groningen temporomandibular joint prosthesis. Development and first clinical application.

Patients with a severely degenerated temporomandibular joint (TMJ) may benefit from an alloplastic TMJ replacement. The aim of the study was to develop a safe and properly functioning TMJ prosthesis. The design was based on imitation of anterior condylar translation by an inferiorly located centre of rotation, unrestricted mandibular movements by a double articulation, correct fit to the skull by a self-adjusting skull part consisting of two connected parts, and stable fixation by bone screws that are rigidly connected to the prosthesis parts. The prosthesis consists of a titanium skull part with ceramic inlay, a titanium mandibular part with a ceramic spherical head, and an intervening polyethylene disc. Titanium-alloy bone screws are used for fixation. All parts are available in a number of different shapes. In vitro laboratory and in vivo animal tests showed a low wear rate, the possibility of a close fit to the skull, a stable fixation, sufficient mechanical strength, appropriate choice of materials and proper functioning. Thereafter the step to first patient application was made. First patient application was carried out without adverse events. In conclusion, the presented TMJ prosthesis passed the pre-clinical tests and has progressed to clinical application. The fit to the skull, the expected lifetime of the device and the reliability of the implantation procedure require further evaluation in well-designed clinical trials.

Adult↗

Long-term results after silicone prosthesis replacement of the proximal pole of the scaphoid bone in advanced scaphoid nonunion.

The treatment of scaphoid fracture nonunion with a small proximal fragment with disturbed circulation and radioscaphoid arthrosis is difficult, and the result is often unsatisfactory. For this reason, in 1981 the replacement of the proximal fragment by a silicone lunate prosthesis was recommended for such cases. From 1980 to 1984, 11 patients (all male, average age 42 [range, 25-59] years) with the conditions described above were treated by silicone prosthesis partial replacement of the scaphoid. In one patient, the prosthesis had to be removed due to dislocation, and in another patient an arthrodesis of the wrist had to be carried out after 5 years due to increasing pain. All nine remaining patients were followed up after an average of 14 (range, 12-16) years, and were clinically and radiologically re-examined and assessed wing the evaluation scheme proposed by Martini (1999). The overall results were satisfactory. Specifically, the outcome was good in one case, satisfactory in six cases, and poor in two cases. Concerning the individual criteria, the best scores were observed in "subjective overall assessment" and in "work and sports", whilst the worst were found in "movement" ad "X-ray". For all patients, X-ray examination revealed both postoperative arthrosis and extensive multiple cystoid osteolysis, presumably due to silicone synovitis. Nevertheless, most patients were free of symptoms. None of the patients felt that further treatment was necessary. Silicone prosthesis partial replacement of the scaphoid leads to long-term reduction in pain and adequate hand function. However, it is not capable of preventing carpal collapse and carpal arthrosis. Furthermore, since in several cases a progressive silicone synovitis developed, the method was rightly abandoned after 1984.

Adult↗