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Evaluation of the Angelchik antireflux prosthesis using a model for esophageal reflux in rhesus monkeys.

Minimal data are available about the Angelchik antireflux prosthesis although it has been inserted in more than 14,000 patients. The present animal study was designed to evaluate the effectiveness and mechanism of action of this prosthesis. A reproducible model of esophageal reflux in primates was created using a double myotomy. Lower esophageal sphincter (LES) pressure and reflux score were improved significantly in animals by insertion of an Angelchik antireflux prosthesis, a modified antireflux prosthesis, or a Nissen fundoplication. Manometrically determined LES length was increased after insertion of an Angelchik antireflux prosthesis but not by a Nissen fundoplication or sham operation. Complications after insertion of the modified prosthesis included intraluminal erosion, fibrous stricture, and slippage of the device over the stomach.

Animals↗

Prosthesis satisfaction outcome measurement in pediatric limb deficiency.

OBJECTIVE: To describe the development and initial psychometric properties of a new outcome measure to assess satisfaction with prosthesis in children with limb deficiencies. DESIGN: Parents of children with limb deficiency were surveyed during routine outpatient clinic visits. SETTING: Two outpatient pediatric clinics. PARTICIPANTS: Ninety-seven parents of children with limb deficiency aged 1 to 17 years. MAIN OUTCOME MEASURE: The newly developed Child Amputee Prosthetics Project-Prosthesis Satisfaction Inventory (CAPP-PSI). RESULTS: Internal consistency reliability is high. Zero-order correlations with prosthesis wear/use patterns and with parent ratings of prosthesis appearance provide support for the construct validity of the CAPP-PSI. CONCLUSION: The CAPP-PSI is a promising, brief, parent-administered inventory for the assessment of prosthesis satisfaction in children with limb deficiency. It may be useful in future research for predicting prosthesis wear and use patterns in this population.

Activities of Daily Living↗

Pitfalls of the Rosen anti-incontinence prosthesis.

There were 17 male patients with urinary incontinence who underwent insertion of the Rosen anti-incontinence prosthesis. Of the 17 patients 9 (53 per cent) have a functioning prosthesis, 4 (23.5 per cent) have a non-functioning prosthesis and are awaiting replacement and 4 (23.5 per cent) have had the prosthesis removed. The longevity of the prosthesis is unknown, with our longest functioning prosthesis at 26 months.

Humans↗

Non-inflatable penile prosthesis for the management of urinary incontinence and sexual disability of patients with spinal cord injury.

During the last 5 years non-inflatable penile prostheses were implanted in 37 patients with spinal cord injury. Operation was done to provide adequate stability of the penis in order to hold an external urinary device, to help erectile impotence and to make self-catheterisation easier. A pair of Shirai-type silicone penile implants were inserted into the corpora cavernosa through a dorsal skin incision at the penile base. In 37 patients 33 had excellent results. Extrusion of the prosthesis occurred in two cases due to infection. Removal of the prosthesis was necessary in a patient who had causalgia in the lower extremities. Posterior migration of the prosthesis was noted in a tetraplegic patient who used to turn on his stomach when he changed clothes. Anterior sphincterotomy which was performed during the surgery in one case and after the surgery in another two cases did not affect the prosthesis. Questionnaire survey revealed that 32 (86%) were satisfied with the procedure which provided better condom fitting and easier intermittent catheterisation whereas only 5 (14%) were dissatisfied. The prosthesis improved sexual function in 15 (41%) patients, 18 (48%) patients were unchanged and four (11%) patients were dissatisfied. Penile prosthesis is an effective manoeuvre for the treatment of urinary incontinence and sexual disability of patients with spinal cord injury provided that the special aspects of the spinal cord injury is taken into consideration.

Adult↗

Penile prosthesis implantation and infection for Sexual Medicine Society of North America.

Penile prosthetics have developed over the past three decades into an effective treatment for erectile dysfunction with high reliability and patient satisfaction rates. The morbidity of these devices is principally limited to mechanical malfunction and the most feared complication of prostheses infection. Most penile prosthesis infections are caused by gram positive skin contaminations such as Staphylococci. The signs and symptoms of these infections may be difficult to identify in early stages, but late infections may lead to tissue loss and poor prognosis for prosthesis replacement. Treatment of penile prosthesis infections is best carried out with a salvage technique including aggressive lavage and prosthesis replacement. The success of this technique is salvage of prosthesis and return to function in more than 80% of cases. While penile prosthesis infection continues to be a dreaded complication, early diagnosis and aggressive surgical treatment may salvage the majority of these implants.

Humans↗

Morbidity of immediate breast reconstruction (IBR) after mastectomy by a subpectorally placed silicone prosthesis: the adverse effect of radiotherapy.

AIMS: This study evaluates the incidence of local complications after immediate breast reconstruction (IBR) following mastectomy with a subpectorally placed silicone prosthesis, with emphasis on the effect of radiation treatment on IBR. METHODS: The medical records of 100 women, who underwent a mastectomy followed by IBR with a subpectorally placed silicone prosthesis at the University Hospital Rotterdam/Daniel den Hoed Cancer Center, between March 1990 and March 1995, were reviewed. Thirteen prostheses were implanted prior to radiation treatment, and 15 prostheses were implanted after irradiation of the chest wall. RESULTS: Early complications were seen in 15% of the IBR and were more often in irradiated women. At long-term follow-up, the most common complication was capsular contracture (21%). This occurred significantly more around prostheses placed in a previously irradiated area (P<0.0005), or which were irradiated after IBR (P=0.001). Loss of prosthesis was seen in 11 cases, and was significantly (P<0.005) more in irradiated women (n=5; 18%) compared to women who were not irradiated (n=6; 7%). CONCLUSIONS: Complications after IBR with a silicone prosthesis were more common in women who were treated with radiotherapy prior to or after IBR following mastectomy than in women who were not irradiated. In particular, capsular contracture around a prosthesis placed in a previously irradiated area was significantly increased. The use of musculocutaneous flaps, such as the transverse rectus abdominis muscle or latissimus dorsi flap, is preferable for reconstruction of previously irradiated breasts. There is no indication to remove the prosthesis before radiation therapy of the chest wall.

Adult↗

Carinal reconstruction with a Y-shaped collagen-conjugated prosthesis.

BACKGROUND: Carinal reconstruction by direct suturing is associated with a high mortality because high tension at the anastomosis can lead to tracheobronchial fistula. A new tracheal prosthesis was therefore designed for reconstruction of the tracheal bifurcation and applied for experimental carinal replacement in dogs. METHODS: The main frame of the new prosthesis consists of a Y-shaped Marlex mesh tube (C.R. Bard, Inc, Billerica, Mass) reinforced with polypropylene spirals, to which collagen extracted from porcine skin is chemically conjugated to provide biocompatibility and airtightness. This conjugated collagen is composed of amorphous and sponge collagen layers. The tracheobronchial bifurcation was replaced with the prosthesis in 10 beagle dogs. RESULTS: Eight dogs survived the postoperative period, and 2 dogs died within 4 days after the operation. Bronchoscopic examination revealed that the tracheal prosthesis was covered with smooth whitish tissue and that no stenosis or dehiscence was present in the 8 dogs even 6 months after the operation. Slight mesh exposure was recognized in 1 dog. Histologic examination revealed that approximately one half of the luminal surface was covered with ciliated columnar epithelium or nonciliated squamous epithelium. In the remaining lumen, especially in the middle portion of the prosthesis, connective tissue without epithelium was observed. CONCLUSIONS: These long-term results indicate that our bifurcated tracheal prosthesis can be used for reconstruction of the tracheobronchial bifurcation with long-term safety.

Animals↗

Collagen coated Y-shaped prosthesis for carinal replacement promotes regeneration of the tracheal epithelium.

Carinal reconstruction has the highest operative mortality rate in pulmonary surgery, and high tension at the anastomoses is one of the reasons. We have reported previously that a new Y-shaped artificial trachea gives acceptable short-term results. Here, we report our long-term observations and histologic findings. A Y-shaped Marlex mesh tube reinforced by a polypropylene spiral was coated with collagen, which was extracted from porcine skin, to increase the biocompatibility and airtightness of the prosthesis. Replacement of the carina was performed in 20 beagle dogs. The prosthesis was covered by the omental pedicle in all dogs. Six of the 20 dogs survived past 6 months, and 4 were in good condition when they were killed. The other 13 dogs died within 11 days of the operation. The main cause of death was air leakage from the prosthesis. Bronchoscopic examination of the surviving dogs 12 months after surgery revealed that the prosthesis was covered with regenerated tissue, and neither stenosis nor dehiscence was recognized; 15 months after implantation microscopic examination showed the growth of ciliated epithelial cells over the lumen of the prosthesis. These results suggest that our Y-shaped artificial trachea might be useful for reconstruction of the carina with tissue regrowth, although some improvement of the prosthesis is necessary.

Animals↗

A biomechanical study of two postoperative prostheses for transtibial amputees: a custom-molded and a prefabricated adjustable pneumatic prosthesis.

We evaluated an adjustable pneumatic prefabricated prosthesis and a rigid custom-molded prosthesis for immediate postoperative use. Twelve transtibial amputations were performed on cadaver limbs. Differential variable reluctance transducers were placed subcutaneously across the wound edge medially and laterally. The limbs were then placed in either the pneumatic prosthesis (five limbs) or the rigid prosthesis (seven limbs). The specimens underwent static and cyclic loading to simulate weight bearing. The strain readings for static and cyclic loading were greater in the rigid prosthetic group. Only the mean medial strain measurement after cyclic loading was statistically significant. The results demonstrate that the pneumatic prosthesis places less strain across the wound than a rigid prosthesis.

Air↗

Incidence, timing, and importance of tracheoesophageal prosthesis resizing for successful tracheoesophageal speech production.

The Blom-Singer method of tracheoesophageal (TE) speech restoration is a proven alternative to esophageal and electrolaryngeal speech in patients with total laryngectomy. This retrospective study was undertaken to determine the incidence and timing of TE prosthesis resizing, amount of change in prosthesis length, etiologies associated with resizing, and importance of long-term professional follow-up for maintenance of successful TE speech production. Participants were 26 individuals with total laryngectomy and secondary TE puncture. Results indicated that all 18 participants available for long-term follow-up required TE prosthesis resizing, and multiple resizings were required in 87% of the routinely followed participants. In 14 participants the prostheses were resized shorter (sample mean [mean] = -0.7 cm); in 3, longer (mean = +0.5 cm); and in 1, from a duckbill to a low-pressure prosthesis of the same size. The mean number of days from initial measurement and fitting to first prosthesis resizing was 26. The importance of collaboration between the speech-language pathologist and otolaryngologist and need for long-term follow-up for successful maintenance of TE speech are stressed. Cost containment of rehabilitation services using the indwelling TE prosthesis is demonstrated.

Adult↗

[Team communication needed in treatment for fixed prosthesis. 1) Opinion from dentist's standpoint].

It is important that a dentist and a dental technician share information about form and function of the restoration to be provided for the patient. The purpose of this paper is to discuss the methods and the contents of communication that a dentist establishes with a dental technician in treatment for fixed prosthesis. The communication is not one-way in which a dentist directs some work content to a dental technician; rather, it is a two-way communication of exchange that includes dental technician's knowledge and skill toward the dentist. A dentist must communicate with a dental technician to express four factors of biocompatibility, function, esthetics and biomechanics in the fixed prosthesis. Provisional restorations are used for embodiment as early as possible, and each other's communication enables smooth sharing of the image of the final prosthesis. It is necessary to inform the dental technician of the contents that are required for fabrication of fixed prosthesis and that cannot be obtained from the model. The fixed prosthesis satisfactory for the patient can be made through cooperation between dentist and dental technician. Furthermore, the strong relationship of mutual trust can realize more reliable fixed prosthesis.

Communication↗

Biologic anchorage of cruciate ligament prosthesis. Bone ingrowth and fixation of the Gore-Tex ligament in sheep.

The biologic fixation and strength of fixation of the polytetrafluoroethylene (PTFE) Gore-Tex ligament prosthesis was investigated in sheep knees. The device was inserted to replace the anterior cruciate ligament according to the recommended technique. Histological bone tunnel evaluation together with mechanical tensile studies were done at 6, 12, and 18 months. Already at 6 months the pull-out load of the prosthesis exceeded that of the normal ligament, and this finding persisted up to 18 months postoperatively. At 6 months there was marked fibrous tissue ingrowth into the prosthesis, and at 12 months trabecular bone had replaced the fibrous tissue between the interstices of the filaments; at 18 months bone even penetrated into the individual porous fibers of the prosthesis. The intra-articular part of the prosthesis was surrounded and partly invaded by undifferentiated connective tissue, with no recognizable macrophages or other inflammatory cells. In this experiment, the biocompatibility and porosity of the Gore-Tex prosthesis seemed optimal to permit ingrowth from surrounding fibrous and osseous tissues and firm anchorage into the bone tunnels.

Animals↗

Designing manufacturing and the clinic application of the prosthesis for the patients with large ocular defects.

PURPOSE: To design and manufacture the prosthesis of external type for patients with ocular large defects. METHODS: Silicon and polymethyl methacrylate (PMMA) were chosen the chief materials: The main procedures are: taking the impression, color mixture, making primitive form of the prosthesis, modification and fixation. RESULTS: Fifty patients with large ocular defects took the prosthesis, the cosmetic results are satisfactory. All the patients give satisfactory comments on the 5 main indexes: color 90%, stereo-feeling 100%, peripheral difference 86%, fidelity 98% and fixation 86%. CONCLUSIONS: To make ocular prosthesis, materials with good quality and complicated technology are needed. The prosthesis made by silicon combined with PMMA show good results. Among the procedures of making prosthesis, color mixture and fixation are the most important.

Eye Neoplasms↗

Treatment of pharyngoesophageal stenosis by polyvinyl prosthesis.

Many authors have objected to the use of esophageal stents in the palliative management of lesions obstructing the cervical esophagus, especially when the prosthesis must lie within 2 cm of the cricopharyngeus muscle (CPM). Ten patients with stenosis of the cervical esophagus by lesions within 2 cm of or involving the CPM were considered for prosthesis placement. The prosthesis was successfully placed in eight patients, five of whom had a tracheoesophageal fistula (TEF). A prosthesis could not be placed in two patients, and two patients complained of a minimal but tolerable foreign body sensation. Six prostheses were custom-made. The necessity to place a prosthesis within 2 cm of or even immediately proximal to the CPM should not be considered an absolute contraindication to esophageal prosthesis placement in selected patients. Foreign body sensation may be absent or minimal, and stent migration is common.

Aged↗

Mentor inflatable penile prosthesis: clinical experience in 52 patients.

The Mentor inflatable penile prosthesis is manufactured from Bioflex polyurethane, a material which is less elastic and more durable than silicone. Use of this new biocompatible polymer eliminates cylinder aneurysms and wear-induced cylinder leaks. The new prosthesis also incorporates a snap-on connector system designed to eliminate connector leaks and decrease operative time. The Mentor prosthesis has been implanted in 52 patients with organic impotence. The patients have been followed up for 2 to 16 months (average 8.3), the follow-up exceeding 1 year in 15 patients. A satisfactory cosmetic and functional result was achieved in 51 cases. Infection necessitated removal of the prosthesis in one patient. There were no pump, reservoir or tubing failures. After early connector failures there were no connector failures in the subsequent 48 patients. Additional complications included an incisional hernia and a cylinder failure which resulted from a manufacturing defect. There were no failures attributable to wear or material fatigue. The inherent reliability of this new prosthesis and the excellent functional and cosmetic results it produces justify its use in any patient who is a candidate for a penile prosthesis.

Adult↗

[Bone-anchored auricular prosthesis].

During the period February 1989-September 1991, 15 patients with absent or defective pinna were treated with a bone-anchored auricular prosthesis at the ENT-department, Rigshospitalet, Copenhagen. These patients were followed up from the hospital records and by means of a questionnaire. Altogether 40 titanium implants have been inserted, of which one implant was found not to be integrated at the time of the second-stage surgery. Five patients underwent additional surgery, one patient because of non-integration of a screw, and four patients on account of soft-tissue reactions. From the questionnaire replies it appears that all patients found the cosmetic result and the technique concerning mounting of the prosthesis very satisfactory. Nearly half the patients found that the care of the skin around the abutments caused considerable problems. Three patients had experienced unintended losses of the prosthesis. In conclusion, treatment with a bone anchored auricular prosthesis has considerable advantages compared to treatment with a prosthesis attached by adhesive. Furthermore the use of a bone-anchored prosthesis should be considered a viable alternative to surgical reconstruction because of the outstanding aesthetic result and because the surgical procedure puts less strain on the patient. The disadvantage of the method is the lifelong daily care of the skin and the dependence on the health services.

Adult↗

Preliminary report on postoperative results of newly designed stable total knee prosthesis.

A newly designed stable total knee prosthesis was made for the severely destructed knee. This prosthesis was named the Yoshino total knee prosthesis, and is a non-hinged type prosthesis consisting of a vitallium femoral component and a ultra-high molecular weight polyethylene tibial component. Clinical results of 127 Yoshino total knee arthroplasties showed the following characteristics: 1) good stability, and 2) good mobility. Stability was exceptionally good, and the results were the same as the hinged total knee prosthesis.

Adult↗

Long-term results and survivorship of the McKee-Farrar total hip prosthesis.

Five hundred and eleven McKee-Farrar prostheses implanted at the Orthopedic Hospital of the Invalid Foundation (Helsinki, Finland) between 1967 and 1973 were analyzed for long-term survivorship, clinical results, and the risk factors leading to aseptic loosening of the prosthesis. Reoperation was necessary for aseptic loosening of 91 prostheses and for septic loosening of 19 prosthesis. Ten-year survivorship was 76% and the annual failure rate 2.3%. The failure rate correlated with time. Acetabular cup loosening occurred 1.2 times more often than stem loosening. The retained prostheses remained clinically stable with respect to pain and mobility, but some deterioration was observed in walking ability. In addition to the follow-up period, prosthetic design, right-sided prosthesis, and lengthening of the operated leg proved to be significant factors for aseptic loosening in multiple stepwise regression analysis. After exclusion of the unmeasured leg length inequalities, the lengthening of the operated leg proved to be the most important factor explaining aseptic loosening of the prosthesis. Surgeon's inexperience, operation time, post-traumatic coxarthrosis, and previous operations were correlated to aseptic loosening of the prosthesis.

Adult↗