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The Anaform endoprosthesis: a proplast-coated femoral endoprosthesis.

The Anaform endoprosthesis study is a prospective trial by 12 orthopedic surgeons from six different hospitals in the Netherlands begun September 1984. As of March 1, 1988, 510 prostheses had been implanted, 60 with a follow up of more than 3 years. Of the 181 patients with a follow up of more than 2 years, 92% had a Harris hip score of more than 80 points. Apart from the main series, the prosthesis was used in 35 patients for revision of a cemented prosthesis, of whom 13 had a follow up of more than 2 years. Of these, ten patients (73%) had a Harris hip score of more than 80 points. Most patients studied were more than 65 years old. Fixation by ingrowth of fibrous tissue in a 2 mm thick, soft, flexible, low-modulus stem coating can provide painless function, clinical stabilization, and normal gait. The Anaform femoral endoprosthesis seems to be of advantage in the young patient as a method of cementless fixation. When necessary, removal without bone destruction is easy.

Clinical Trials as Topic↗

Long-term outcomes after total alloplastic temporomandibular joint reconstruction following exposure to failed materials.

PURPOSE: Total alloplastic temporomandibular joint (TMJ) reconstruction is often necessary because of the significant bony destruction resulting from failed Proplast-Teflon (Vitek, Houston, TX) and/or Silastic (Dow Corning, Arlington, TX) foreign body inflammatory reactions. Multiply operated and functionless, TMJ patients likewise have undergone total alloplastic reconstruction. Many of these patients were also exposed to failed TMJ implant materials. It was the purpose of this study to evaluate a population representative of both these groups of patients reconstructed with the Techmedica (now, TMJ Concepts, Ventura, CA) Total TMJ System to determine whether the long-term subjective and objective outcomes were affected by either the presence of the previously failed TMJ implant materials, the number of prior procedures, or both. PATIENTS AND METHODS: One hundred ninety-eight patients who had been implanted with 332 Techmedica System total joints between 1990 and 1994 where divided into 4 groups based on their prior exposure to failed TMJ implant materials: group I, Proplast-Teflon (82 patients, 135 joints); group II, Silastic (28 patients, 46 joints); group III, both Proplast-Teflon and Silastic (25 patients, 46 joints); and group IV, no prior exposure to Proplast-Teflon or Silastic (63 patients, 105 joints). The mean follow-up was 60.2 +/- 40.3 months (range, 2 to 120 months). To determine whether exposure to either or both failed implant materials affected the long-term subjective and objective outcome variables, the groups were compared statistically using multivariate mixed modeling with age, sex, number of prior operations, years with TMJ problem, prior implant type, and implant sides as independent variables, and the relevant baseline measure as covariates. RESULTS: For the subjective variables, patients exposed to Proplast-Teflon or Silastic had significantly higher mean pain scores long-term. The type of prior failed TMJ implant material was not statistically significant with regard to function. Patients exposed to Proplast-Teflon reported poorer diet consistency scores long-term. Objectively, patients with 5 or fewer prior TMJ surgeries exposed to neither failed implant or Silastic reported better long-term mean maximum interincisal opening than did those patients exposed to Proplast-Teflon or both failed materials. However, for patients with 6 or more prior TMJ surgeries, those exposed to Proplast-Teflon or both failed materials reported less decrease in mean maximum interincisal opening over time. CONCLUSION: These data confirm what has been observed clinically, that in the population studied, multiply operated patients previously exposed to failed Proplast-Teflon alone or both failed Proplast-Teflon and Silastic have poorer reported long-term outcomes with alloplastic reconstruction. However, the total alloplastic TMJ reconstruction devices used in this study remained functional.

Adult↗

[Formation of a microvascular, multilayer constructed transplant using the greater omentum].

The high potential for vascularisation of the greater omentum, described in the literature and in our own investigations was used to build microsurgical compound island flaps containing hard tissue grafts like Proplast. In the first operative procedure Proplast was inserted into the omentum and a flap was formed pedicled on the right gastro-epiploic vessels and transposed into the subcutaneous layer. Two to three weeks later the vascularized Proplast could be removed together with the overlying skin and fat. In another experiment Proplast was inserted into the pedicled omentum and put back into the belly. A second laparotomy was performed 14 days later to cover the omentum-Proplast sandwich with a split skin allograft. In both experiments the total compound sandwich flap was supplied only by the right gastro-epiploic vessels, which allowed a microsurgical transplantation.

Animals↗

A new alloplastic material for ophthalmic surgery.

The application of Proplast in ocular surgery is in an early stage. We believe our preliminary work may offer a solution to the problem of erosion and slippage common to other types of implants. We are currently investigating the potential of Proplast in keratoprosthesis. Proplast may prove useful in buckles and implants for retina detachment as well as stabilizing splints for blow-out fractures. Proplast is an inert, carbon and Teflon alloplast, not previously described in the ophthalmic literature. Corneal and scleral implants in rabbits are well tolerated. Proplast is porous and microscopic examination of the implants show fibrovascular ingrowth within its matrix, thereby incorporating it into the host tissue. The rate at which the implant is incorporated by host tissue ingrowth and the long-term acceptance of the alloplast have yet to be determined.

Animals↗

The fate of alloplastic materials placed under a burn scar: an experimental study.

The behavior, under burn scars, of three different alloplastic materials, silicone, Medpor and Proplast, was compared in an animal model. A standard burn wound was created in rats, and 3 months later silicone, medpor and proplast alloplasts were placed under the burn scar. The rats were followed for another 3 months and ulceration and/or alloplast exposure rates were evaluated. At the end of this period specimens were examined histologically for the thickness of the fibrous capsule around the implant, thickness of the overlying tissue, tissue ingrowth and vascularization of the implants. Ulceration and exposure occurred in 2 of the 12 Medpor, 2 of the 12 Proplast and none of the 12 silicone implants. Fibrous capsule was significantly thicker around the silicone implants. Tissue ingrowth and vascularization were most prominent in Medpor implants while thickness of the overlying tissue was maximum in Proplast implants. These findings suggest that complications with silicone implants may be less than with other porous implants when used under burn scarred tissue.

Analysis of Variance↗

The use of alloplastic materials in secondary rhinoplasties: 32 years of clinical experience.

BACKGROUND: A retrospective evaluation of the authors' 32 years of experience in revision rhinoplasty is presented. The authors suggest that iatrogenic nasal deformities are studied under four groups on the basis of their location and the affected structures: lower third, middle third, upper third, and combined deformities. The authors also present the vertical columellar incision for insertion of alloplastic implants and cartilage grafts, a genuine approach avoiding contamination with the nasal flora. METHODS: A total of 182 cases were studied, as follows: lower third (n = 81), middle third (n = 65), upper third (n = 17), and combined (n = 19) deformities. The mean age of the patients was 40 years. RESULTS: Our follow-up was a minimum of 2 years, and some of the cases with Proplast implants have been followed for as long as 21 years. During this rather long follow-up, only two of the Proplast implants had to be removed (one because of an acute infection and the other because of a chronic infection causing extrusion after 5 years). CONCLUSIONS: The authors have always preferred to use autogenous cartilage grafts for tip deformities and Proplast implants for middle and upper third saddle nose deformities whenever necessary. Their long-term results with Proplast for more than 20 years show that alloplastic materials may be as reliable as autogenous implants if the surgical principles are met and the cases are carefully selected.

Adolescent↗

Histopathological observations on polyethylene-type materials in chronic ear surgery.

Proplast implants were used in reconstruction of the posterior ear canal wall in one ear and in obliteration of the cavity in two ears. All ears healed well but the canal wall implant became visible in 15 months and had to be removed because of persistant suppuration. The other two implants became visible 3 to 4 years postoperatively. Plastipore TORPs were implanted in two ears undergoing revision surgery. One prosthesis was removed several months later because of infection, and the other 1 year after surgery, as no improvement in hearing had been achieved. Histologically, masses of giant cells were seen in the implants and many cells had engulfed both the vitreous carbon material of Proplast and the white Teflon material of both Proplast and Plastipore. It is concluded that Proplast is unsuitable either for canal wall reconstruction or for cavity obliteration. Plastipore should be used only as a bridge between two ossicles. If the implant must be applied to the tympanic membrane, that end should be fitted with a nonabsorbable bony homograft, which does not cause foreign body reaction.

Biocompatible Materials↗

A comparison of porous composite PTFE/graphite and PTFE/aluminum oxide facial implants in primates.

Comparison of tissue ingrowth density values for Proplast I and its aluminum oxide analog, Proplast II, when implanted on the primate infraorbital rim and inferior border of the mandible, showed no difference between the two test materials. A similar comparison of local cellular response ratings showed slightly less response to Proplast II. Microscopic and clinical examination did not otherwise reveal any significant differences in biologic reaction to these materials.

Aluminum↗

Reconstruction of the airway with a composite alloplastic and autogenous graft. An experimental study.

A method by which an alloplast can be lined with mucosa and thereafter used as a composite pedicled graft is described and discussed. Autogenous buccal mucosa was transplanted to the pretracheal region in five beagles. Subsequently a cyst developed in which the graft constituted the main part of the cyst wall. After 5 to 6 weeks the cyst was explored and a Proplast sheet was sutured to its exterior. After another 3-9 weeks the area was explored again. A composite graft had then formed comprising buccal mucosa on the outside, stabilized by Proplast and supplied by blood vessels arising from the strap muscles and their fascia. After opening of the cyst, the composite graft was used to repair a tracheal defect in the same dog. All of the dogs survived and they did not lose any weight. The graft areas were removed 5 1/2-9 months after the tracheal window repair. Tracheoscopy was performed at least twice on each dog. The grafted areas were also studied by light microscopy, scanning electron microscopy and transmission electron microscopy. The grafts survived in all cases. There was no tendency towards graft extrusion. Connective tissue cells predominated in the pores of the Proplast framework, in which small foci of metaplastic bone formation were also seen.

Animals↗

Experimental evaluation of a new implant material in frontal sinus obliteration: a preliminary report.

Frontal osteoplasty with exogenous material has been uniformly unsuccessful both experimentally and clinically. Our experiment was designed to test the long-term behavior of a new poly (tetrafluoroethylene)-carbon fiber implant material (Proplast) in a canine frontal sinus model. Varying conditions such as removal of the sinus mucoperiosteum, closure of the nasofrontal ducts, exposure of dura mater, and cerebrospinal fluid leaks were studied at intervals up to one year. Proplast was 100% successful in obliteration of the canine frontal sinus. The ultraporous nature allowed rapid vascularization, collagen ingrowth, and new bone formation, and led to stabilization rather than sequestration. Frontal obliteration with Proplast may be clinically superior to osteoplasty with any other presently available exogenous material or with osteoneogenesis alone, and may even obviate the few complications encountered with adipose implants. Only longer range experimental and clinical evaluation will provide the answer.

Animals↗

Anterior cruciate reconstruction in the chronically unstable knee using an expanded polytetrafluoroethylene (PTFE) prosthetic ligament.

The purpose of this study is to review 30 patients with failed, multiply operated knees, or knees with gross instability which were reconstructed using the expanded polytetrafluoroethylene (PTFE) prosthetic ligament as a substitute for the ACL. The results were then compared with our experience with the proplast ligament used in a previous clinical series. This prospective review evaluated the patients preoperatively and at regular intervals during the postoperative period. The average followup was 24 months postoperation. Eighty-three percent of the patients had a satisfactory result, scoring greater than 140 points on a 200 point knee grading scale. Objectively, the anterior instability pattern was improved in 87% of the knees. Subjectively, pain of at least a mild degree persisted in 70% of the patients postoperatively. This pain seemed to correlate with articular cartilage changes documented intraoperatively. Major complications occurred in two patients. In conclusion, the PTFE prosthetic ligament was an improvement over the proplast ligament in the reconstruction of the multiply operated, unstable knee. The 83% satisfactory rate with the PTFE was promising compared to a 52% satisfactory rate using the proplast ligament. However, we encourage future long term studies of the PTFE prosthetic ligament in the reconstruction of the ACL in the chronically unstable knee.

Humans↗

[Vascularization and resorption of different supporting tissues by the greater omentum in the formation of compound microvascular transplants].

In former investigations the author described the use of omentum majus in building microsurgical compound island flaps employing supporting tissue. Now different kinds of hard tissue, such as autogenous bone and cartilage, allogenous bone and cartilage (preserved by Cialit-solution), Teflon-Fluorocarbon Polymer (Proplast) and tri-calcium phosphate were presented in omentum-sandwich flaps in a histological investigation. We paid special attention to resorption and vascularisation of hard tissue. Allogenous cartilage grafts or artificial materials like Proplast were the most suitable to put into a compound omental island flap. There was good vascularisation with no resorption, especially with Proplast.

Animals↗