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Long-term patency of regenerated neoaortic wall following the implant of a fully biodegradable polyurethane prosthesis: experimental lipid diet model in pigs.

The degradation of a polyurethane vascular prosthesis, the time course and characteristics of tissue ingrowth and prosthesis replacement, and the incidence of thrombosis have been investigated in 50 young pigs. A 6-7 cm long cone-shaped prosthesis was implanted in the infrarenal aorta of 50 young growing pigs which were sacrificed at intervals from 60 to 365 days. Ten animals were controls, 25 were given aspirin 10 mg/kg of body weight/day, and 15 were fed with cod liver oil. Aortography, done at 30, 60, and 90 days, showed 100% of implants were thrombosed in the surviving controls, 55% of the aspirin group had patent grafts, and 100% of animals in the lipid diet group had patent grafts. At final graft retrieval, the aspirin group showed only three patencies, while in the lipid diet group seven out of nine animals were patent. The laboratory and morphological studies indicated that all patent prostheses were lined with tissue that resembled the intima of native aorta with a layer of smooth muscle cells which appeared complete at 180 days. From these data we conclude that the biodegradable polyurethane vascular prosthesis is reliable for experimental implants in a pig model. The lipid-rich diet of polyunsaturated fatty acids potentiates long-term patency, perhaps by preventing platelet aggregation and thrombosis, and allowing the growth of a neoendothelium and neomedia within the lumen of the prosthesis, which slowly degrade towards fatty tissue and form neoadventitia.

Animals↗

Quality of life assessment in patients with implant-supported and resin-bonded fixed prosthesis for bounded edentulous spaces.

OBJECTIVES: Dental implants have become increasingly popular in the prosthetic rehabilitation of patients with bounded edentulous spaces. Oral condition-related quality of life (QOL) levels have rarely been assessed in these patients. MATERIAL AND METHODS: Two groups of subjects with bounded edentulous spaces were studied: an implant-supported fixed prosthesis group (11 patients) and a resin-bonded fixed prosthesis group (33 patients). The two groups were well matched in terms of sex, age, missing units and location of missing units. The patients were requested to answer a self-administered QOL questionnaire with two major subscales - oral condition- and general condition-related QOL scores. The test-retest reliability of each question was pre-examined and found acceptable (mean Spearman rank correlation coefficient was 0.55 +/- 0.16). Mean QOL score differences between the two groups were analyzed by the Mann-Whitney U-test. RESULTS: Mean oral condition-related QOL scores of the implant-supported and resin-bonded fixed prosthesis groups were 87.8 +/- 9.5 and 87.1 +/- 12.3% (P = 0.85), and mean general condition-related QOL scores were 73.8 +/- 14.8 and 71.6 +/- 15.2% (P = 0.95), respectively. No significant QOL differences between the two groups were observed in the two subscales. CONCLUSION: In patients with bounded edentulous spaces, multidimensional QOL levels of patients with an implant-supported fixed prosthesis do not exceed those of patients with a resin-bonded fixed prosthesis in a short follow-up period.

Adult↗

Analysis of a device for assessment of abutment and prosthesis screw loosening in oral implants.

Screw loosening is an irritating problem in implant dentistry. Loosened abutment screws and prosthesis screws are often found at yearly examinations. Loosened screws may cause costly complications, such as screw fractures and fracture of the framework, and methods to prevent them would be welcome. The purpose of this study is firstly to describe a mechanical protractor device designed to fit the electrical Torque Controller (Nobel Biocare, DEA 020, Gothenburg, Sweden) and measure the number of degrees necessary to retighten the abutment screw or the prosthesis screw to reach the target torque value. A second purpose is to analyse the precision and validity of the device. The results of the study indicate that the degree of preset loosening of abutment and prosthesis screws can be well reflected in the number of degrees necessary for retightening. It was also shown that it is possible to retighten the abutment and prosthesis screws with a precision of 1.7 degrees and 1.3 degrees, respectively. The study shows that the device has good precision and validity. By using this device, we hope to be able to evaluate various parameters for screw stability, such as the type of implant system, the number of fixtures, the type of abutments, the type of bridge material and the need for retightening of the abutment and prosthesis screws.

Algorithms↗

Within-subject comparisons of maxillary fixed and removable implant prostheses: Patient satisfaction and choice of prosthesis.

Dental implants provide patients with restorative options for the edentulous maxilla. Both fixed and removable prostheses can be attached to the edentulous maxilla, but the efficacy of different designs has not been determined. In this two-session within-subject crossover trial we compared maxillary implant retained fixed prostheses with removable implant overdentures opposed by mandibular implant-supported overdentures. Sixteen patients, who had previously received mandibular implants, entered the study and received four to six maxillary implants. After dropouts as a consequence of a lack of osseointegration and general health problems, 13 remained. Of these, five received the removable prosthesis first and eight the fixed prosthesis. After 2 months, the prostheses were exchanged and the second was also worn for 2 months. Psychometric measurements of general satisfaction with the prostheses as well as comfort, ability to speak, stability, esthetics, ease of cleaning and occlusion were obtained once each prosthesis had been worn for 2 months. Chewing ability was assessed for seven types of food. Removable long-bar overdentures received significantly higher ratings of general satisfaction than fixed prostheses (P = 0.003). Patients also rated their ability to speak and ease of cleaning significantly better with the removable overdentures. Nine patients chose to keep the removable prosthesis and four preferred to keep the fixed prosthesis. The results suggest that maxillary removable overdentures on multiple implants may provide patients with better function than fixed prostheses.

Attitude to Health↗

Experience with the Ultrex and Ultrex Plus inflatable penile prosthesis: new implantation techniques and surgical outcome.

The Ultrex and Ultrex Plus penile prosthesis incorporate sequential design modifications that afford important functional advantages that reduce the potential for mechanical failure. This retrospective study reviews our experience with these models emphasizing innovations in surgical technique and postoperative results. Implantation of Ultrex (31%) and Ultrex Plus (69%) penile prosthesis was performed in 90 impotent men with organic erectile dysfunction following comprehensive multi-disciplinary evaluation. During a follow-up interval of 7-50 months, postoperative outcome was assessed. Of this group, 10% underwent simultaneous explant of another malfunctioning inflatable device or conversion from a semi-rigid prosthesis due to patient preference. Of the remainder, 20% selected implant surgery as their primary therapy while 73% were initially treated with various nonsurgical options prior to implantation. In all patients we employed a single peno-scrotal incision and applied the concept of controlled radial dilatation of all compartments. In our last 32 consecutive patients including eight with previous radical pelvic surgery, we utilized the preperitoneal distention balloon (PDB) facilitating safe and non-traumatic creation of the prevesical space for reservoir insertion. Post operative complications occurred in 8% of patients including pump infection and corporal deformity requiring reimplantation with AMS 700 CX cylinders, or self-contained unitarian prosthesis as a salvage procedure. Satisfactory, functional and anatomic outcome was reported in 95% of patients. Interim advances incorporated into the Ultrex and Ultrex Plus prosthesis have markedly reduced mechanical failure during our follow-up interval of up to 50 months. Importantly, controlled, non-traumatic radial dilatation of the prevesical space by the PDB may encourage broader use of the multicomponent inflatable models, particularly in a setting of pelvic fibrosis due to previous pelvic surgery or radiation.

Adult↗

A surgical algorithm for penile prosthesis placement in men with erectile failure and Peyronie's disease.

We developed an algorithm for surgical management and placement of penile prostheses in patients with erectile failure (ED) and Peyronie's disease (PD). We identified 46 men ages 40 to 77 y with PD who could not attain an adequate erection with sexual stimulation and pharmacotherapy. All men were candidates for penile straightening and inflatable prosthesis placement using the following algorithm. Manual molding was attempted initially, followed by tunica incision for insufficient straightening. For tunical defects greater than 2 cm, polytetrafluoroethylene (PTFE) patch grafting was performed to prevent prosthesis cylinder herniation and recurrent deformity from cicatrix contraction. Mean preoperative penile curvature was 53 degrees (0-90). Prosthesis implantation with manual molding, implant with plaque incision, and implant with plaque incision and PTFE grafting were successfully accomplished in 25 (54%), 12 (26%), and nine (20)% respectively. Mean follow-up was 39 months (range 1-74). Full erectile capacity with a straight phallus was achieved in all patients. Complications included temporary (< 8 months) decreased penile sensation in four (9%), mild (< 2 cm) penile shortening in three (7%), delayed ejaculation in one (2%), and infection requiring explanation in one diabetic male (2%). All of the implanted prostheses provided satisfactory rigidity with no mechanical failures or recurrent curvature. We conclude that inflatable penile prosthesis implantation is a safe and effective therapy with a high satisfaction rate in men with ED and PD. The developed algorithm helps define prosthesis placement and straightening techniques to obtain optimal results with minimal complications.

Adult↗

Multi-institutional outcome study on the efficacy of closed-suction drainage of the scrotum in three-piece inflatable penile prosthesis surgery.

Infection is a devastating complication of penile prosthesis surgery that occurs in approximately 2-5% of all primary inflatable penile primary implants in most series. Prevention of hematoma and swelling with closed-suction drains has been shown not to increase infection rate and yield an earlier recovery time. Despite the intuitive advantages of short-term closed-suction drainage in reducing the incidence of postoperative scrotal swelling and associated adverse effects, many urologists are reluctant to drain the scrotum because of a theoretical risk of introducing an infection. In conclusion, this study was undertaken to evaluate the incidence of infection in three-piece penile prosthesis surgery with scrotal closed-suction drainage. A retrospective review of 425 consecutive primary three-piece penile prosthesis implantations was performed at three institutions in New Jersey, Ohio, and Arkansas from 1998 to 2002. Following the prosthesis insertion, 10 French Round Blake (Johnson & Johnson) or, in a few cases, 10 French Jackson Pratt, closed-suction drains were placed in each patient for less than 24 h. All subjects received standard perioperative antibiotic coverage. Average age at implant was 62 y (range 24-92 y). Operative time (incision to skin closure) was less than 60 min in the vast majority of cases. There were a total of 14 (3.3%) infections and three hematomas (0.7%) during an average 18-month follow-up period. In conclusion, this investigation revealed that closed-suction drainage of the scrotum for approximately 12-24 h following three-piece inflatable penile prosthesis surgery does not result in increased infection rate and is associated with a very low incidence of postoperative hematoma formation, swelling, and ecchymosis.

Adult↗

Speech intelligibility following maxillectomy with and without a prosthesis: an analysis of 54 cases.

To statistically evaluate the factors that influenced speech following maxillectomy, the speech intelligibility (SI) in 54 patients was measured with and without a prosthesis. The mean SI score without a prosthesis in all patients was 35.7 +/- 22.7% and that with a prosthesis was 84.9 +/- 12.7%. The results of the postmaxillectomy SI statistical analysis revealed that an oro-nasal communication was one of the factors that influenced SI without a prosthesis. The resection of the anterior portion of the soft palate was one of the factors that influenced SI with a prosthesis, which suggested that for some of these patients we should consider specific surgical treatment, aimed at the reconstruction in the deep defect extending to the intratemporal fossa. A new classification of maxillary defects has been proposed which will help to predict the grade of post-maxillectomy speech disorder following surgery.

Adult↗

The management of low-flow priapism with the immediate insertion of a penile prosthesis.

OBJECTIVE: To evaluate the outcome of patients undergoing the immediate insertion of a penile prosthesis as a treatment for acute low-flow priapism. PATIENTS AND METHODS: Eight patients presenting with low-flow priapism with a mean duration of 91 h (range 32-192) were prospectively evaluated. All had failed conservative management with the instillation of alpha-adrenergic agents, and four had already undergone shunt procedures elsewhere. Immediate management consisted of the insertion of a malleable prosthesis in six patients and an inflatable prosthesis in two. One of the malleable prostheses was subsequently changed to an inflatable device. RESULTS: There were no early complications, with all patients being satisfied with the end result, and seven having sexual intercourse. One patient developed a penile deformity after surgery, cause by fibrosis around one inflatable cylinder. All patients have maintained their penile length. CONCLUSIONS: Prolonged low-flow priapism results in a variable degree of cavernosal fibrosis and a subsequent loss of penile length. The delayed insertion of a penile prosthesis can be difficult, with high complication rates. The immediate insertion of a penile prosthesis in patients with prolonged low-flow priapism is simple and maintains penile length. This should always be offered to the patient at initial presentation, as the complication rate is low and the subsequent outcome excellent.

Adult↗

The bicipital groove as a landmark for orientation of the humeral prosthesis in cases of fracture.

We studied 45 dry cadaveric humeri to determine whether the bicipital groove of the humerus can be used as a landmark for a proper, individualized orientation of a humeral prosthesis, especially in the case of a fracture. We performed 3 computed tomography sections (at a level just below the lower portion of the head, at the middle of the humeral head, and at a distance 5 cm below the first section), and we used special software for 3-dimensional image processing. To reproduce the individual posterior version of the head, when a humeral prosthesis is implanted for fracture, the lateral fin of the prosthesis should be a mean distance 5.2 +/- 2.6 mm (-1.5 to 10.7 mm) from the posterior edge of the bicipital groove. If the lateral fin of the humeral prosthesis seats just behind the posterior edge of the bicipital groove, a difference of -6.3 degrees to 41.7 degrees from the normal posterior version occurs. A new, simple methodology for an individualized posterior version of a humeral prosthesis in cases of fracture is proposed. We applied this in 6 consecutive patients with fracture of the humeral head that required hemiarthroplasty.

Cadaver↗

An unusual complication of a myoelectric prosthesis.

This clinical note describes an unusual and previously unreported complication of wearing a myoelectric prosthesis in a child with congenital upper limb deficiency. After an initial period of wearing a cosmetic prosthesis, he was provided with a child's trans-radial myoelectric prosthesis with a Steeper Scamp Electric hand at the age of 21 months. After successful and uncomplicated use of this prosthesis for 2 years--a sudden onset of burns of the skin of the stump underlying the single electrode site was noted. The cause of the burns was thought to be due to heat generated from electrical failure possibly from ingress of moisture. This complication has not before been experienced in the authors' centre, nor has it been reported in the literature. While constant improvements are being made in the field of electrically powered prosthesis, the rehabilitation team should be aware of this unusual complication.

Amputation Stumps↗

Aortic and mitral valve replacement with the St. Jude Medical prosthesis.

From April 1, 1979 to August 31, 1983, 228 patients underwent isolated aortic (AVR) (118) or mitral (MVR) (90) valve replacements with a new tilting disc valve prosthesis, the St. Jude prosthesis, at the Medical University of South Carolina. Age ranged from 6 to 84 years (mean 49.1 +/- 19.2 AVR, 44.5 +/- 16.5 MVR). Male sex predominated in the AVR group (68%) and female sex in the MVR group (68%). Thirty-five patients (16.8%) had associated coronary bypass surgery (AVR 23.7%, MVR 7.8%). There were seven deaths (3.4%) occurring during the same hospitalization (AVR: 3/118, 2.5%; MVR: 4/90, 4.4%). Follow-up is 97.6% complete and ranges from 1 to 54 months (mean 19.6 +/- 12.4). In the AVR group, nine late deaths have occurred and actuarial survival at 42 months is 86.7 +/- 3.8%. Three patients have sustained thromboembolic episodes for a linearized rate of 1.6% patient-year, and the probability of remaining free of thromboembolism at 42 months is 96.9 +/- 1.8%. The mean improvement in functional class from preoperative to postoperative is 3.1 +/- 0.7 to 1.2 +/- 0.4 (p less than 0.001). In the MVR group, there have been four late deaths, and the actuarial survival at 42 months is 89.3 +/- 3.8%. Two patients have sustained thromboembolic complications for a linearized rate of 1.2%/patient-year, and the probability of remaining free of thromboembolism at 42 months is 97.2 +/- 2%. The mean improvement in functional class from before to after surgery is 3.2 +/- 0.7 to 1.3 +/- 0.5 (p less than 0.001). There have been no thromboses of the St. Jude valve in the mitral or aortic position, no mechanical failures, and no patient has had significant valve-related hemolysis. Because of this experience, the St. Jude Medical heart valve prosthesis is our prosthesis of choice for any patient undergoing valve replacement with a mechanical prosthesis.

Adolescent↗

Replacement of a tracheal defect with autogenous mucosa lined tracheal prosthesis made from polypropylene mesh.

Reliable prosthetic or tissue grafts for the trachea have not, as yet, been developed for reconstruction of large, circumferential tracheal defects. Major limitations are anastomotic dehiscence and stenosis, attributed to the poor epithelialization and vascularization of the prosthetic graft. We have developed a new tracheal prosthesis that has a well vascularized and viable mucosa. The prosthesis consists of a Prolene mesh reinforced with polypropylene rings, and coated with gelatin. We lined the luminal surface of the prosthesis with transplanted autogenous oral mucosa, wrapped the prosthesis with greater omentum, and placed it in the peritoneal cavity for 2 weeks. Complete surgical resection and replacement of a segment (5 cm in length, 8 to 10 tracheal rings) of the thoracic trachea was then performed in nine adult mongrel dogs. The transplanted mucosa was well vascularized and maintained its normal histology in prereplacement analysis. Dogs with tracheal replacement regained their full activity and did not show any respiratory problems until sacrifice at 1, 2, and 6 months. After 6 months, the prostheses were completely incorporated by the host trachea in all dogs and confluent epithelialization was confirmed histologically from the upper to the lower anastomotic site of the prosthesis; furthermore, the transplanted mucosal cells had changed to ciliated columnar epithelium.

Animals↗

A new L-shaped titanium prosthesis for total reconstruction of the ossicular chain.

OBJECTIVE: To describe the technique used for total ossiculoplasty with the Fisch titanium total prosthesis and evaluate the 1-year postoperative functional results in patients presenting with the stapes (or footplate) without the malleus handle. STUDY DESIGN: Prospective trial with preoperative and postoperative comparison. SETTING: Academic and private practice tertiary care center for otologic surgery. PATIENTS: Forty-nine consecutive patients operated on from September 1996 to December 2000. SURGERY: : Staged ossicular reconstruction with a Fisch titanium total prosthesis placed between the footplate and the tympanic membrane without regard to the presence or absence of the stapes arch. Coupling of the prosthesis to the footplate was achieved by various techniques, including perforation, foot and spike on the footplate without perforation, and shaft alone (without foot) with tragal cartilage fixation (disc or small wedges). There was no interposition of cartilage between the prosthesis head and the tympanic membrane. MAIN OUTCOME MEASURES: Pre- and postoperative air and bone-conduction thresholds and air-bone gaps for pure-tone averages of three and four frequencies and for single frequencies. RESULTS: Postoperative air-bone gap closures within 20 dB distributed equally (50%) between 0.5, 1, and 4 kHz and reached the highest rate (89%) at 2 kHz (p < 0.05). The postoperative air-bone gaps for pure-tone averages reached 0 to 20 dB in 57% and 0 to 30 dB in 87% of the cases. There were no dead ears and no partial or total extrusions of prostheses. The best functional results were achieved through perforation coupling of the spiked foot to the footplate in large oval windows and after fixation of the shaft (without foot) with tragal cartilage disc in narrow oval windows. CONCLUSION: The functional results of the L-shaped Fisch titanium total prosthesis implanted in ears with the stapes but no malleus handle are best at 2 kHz and better than those of comparable columellar titanium prostheses over the remaining tested frequencies.

Adult↗

Comparison of multisegment anterior cervical fixation using bone strut graft versus a titanium rod and buttress prosthesis: analysis of outcome with long-term follow-up and interview by independent physician.

STUDY DESIGN: A retrospective study of 73 consecutive patients who underwent cervical corpectomy and anterior strut fixation over 3 or more disc levels between July 1989 and May 1999. OBJECTIVE: To compare the efficacy of cervical spine fixation by autologous strut graft from iliac crest or fibula versus a titanium prosthesis without bone graft. SUMMARY OF BACKGROUND DATA: Strut grafting after multilevel anterior cervical corpectomy remains a challenging procedure, with published dislocation rates from 0% to 71%, and nonunion from 0% to 54%. This paper describes a quicker and easier alternative to the use of a bone strut, imparting a very high degree of immediate spinal stability, and osseous integration equivalent to bone fusion. METHODS: Thirty-eight bone-graft operations and 38 titanium prosthesis operations were performed on 73 patients between July 24, 1989 and May 20, 1999. Average follow-up was 53.2 months (range 19.8-134). RESULTS: The group of patients who received the prosthesis was significantly older than the bone-grafted group and required significantly more segments excised, but operation times were significantly shorter than for the bone strut operation. The titanium prosthesis had a lower incidence of dislodgement in the early postoperative period (1/38 vs. 4/38 for bone struts) but a higher rate of late reoperation (4/38 vs. 1/38 for bone struts). The SF-36 scores in the domain of Physical Function (only) were significantly higher in the bone-grafted group (P = 0.016, Mann Whitney), consistent with the difference in mean ages of the 2 groups. The groups were indistinguishable by Odom criteria, patient verdict, pain scores, analgesic intake, length of hospital stay, radiologic fusion rate, and residual symptoms. CONCLUSION: A titanium rod and buttress prosthesis may be a faster and easier alternative to conventional iliac crest/fibula autograft after multisegmental cervical vertebral corpectomy.

Adult↗

Combined penile plication surgery and insertion of penile prosthesis for severe penile curvature and erectile dysfunction.

PURPOSE: For persistent penile curvature after corporeal dilation and prosthesis placement other maneuvers, such as plaque incision with or without grafting, or penile modeling, must be used to complete penile straightening. However, each of these techniques is associated with increased morbidity, which includes higher rates of infection and urethral injury. We describe a new technique for correcting severe penile curvature and erectile dysfunction using combined penile plication and placement of a 3 piece inflatable penile prosthesis. MATERIALS AND METHODS: Between February 2000 and June 2003, 5 patients with erectile dysfunction and severe curvature for which other treatment modalities had failed were treated with combined inflatable penile prosthesis and additional plication to correct the severe malformation. Detailed medical and sexual history was obtained as well as preoperative duplex ultrasound prior to surgery. RESULTS: The age range of our patient population was 22 to 55 years. In each case penile prosthesis placement was insufficient to correct the malformation and the addition of multiple plication sutures was required. The malformation in all patients was corrected with this technique. To date no patients have reported any complications with followup (range 3 to 36 months). CONCLUSIONS: In cases of severe penile deformity and curvature with erectile dysfunction the combination of penile plication and inflatable penile prosthesis placement is a method of repair that is well tolerated.

Adult↗

Study of osteointegration of a titanium prosthesis to the stapes: observations on an accidentally extracted stapes.

BACKGROUND: Titanium is a well-established implant material, and its use in ossicular chain reconstruction during middle ear surgery is increasing. HYPOTHESIS: Bony fixation of titanium prostheses has to be considered using this material. Contact with bony structures of the middle ear may result in immobilization. In revision procedures, there is a potential risk of damaging or extracting adherent structures such as the stapes. METHODS: This is a case report of an accidentally extracted stapes resulting from bony fixation of a titanium prosthesis in revision tympanoplasty. The surgical specimen was examined by microscopy, histology, and scanning electron microscopy. Energy dispersive x-ray analysis was used to confirm the elemental composition of the extracted stapes and the titanium prosthesis. RESULTS: The prosthesis showed good biocompatibility at the implantation site, with signs of bone resorption of the stapes suprastructure. However, bony fixation of the undersurface of the prosthesis foot to the stapes footplate was confirmed by ultrastructural analysis. CONCLUSION: In revision tympanoplasty, bony fixation of the titanium prosthesis should be considered.

Audiometry, Pure-Tone↗

Endoscopic management of intragastric migration of an Angelchik prosthesis.

The Angelchik prosthesis was devised as a simple surgical solution for reflux oesophagitis. Since 1983 there have been increasing reports of complications attributed to the prosthesis, the more serious being transmural erosion through the oesophageal or gastric wall. The majority of these have required repeat surgery, which is not without risks. A case report of an Angelchik prosthesis incompletely eroding into the stomach is presented. The prosthesis was tethered by a 1 cm-thick mucosal bridge which precluded simple extraction. Using an endoscopic sphincterotome, the bridge was divided and the prosthesis removed. Endoscopic methods of extracting intragastric Angelchik prostheses should be considered before surgery is undertaken for this complication.

Aged↗