Effect of totally absorbable implant volume on wound infection rate: Study of 2500 operated fractures, osteotomies, and ligament injuries

Between November 1984 and January 1994 in our department, a total of 2500 patients were treated with totally absorbable internal fixation devices. We studied these patients and analyzed results with regard to the volume of the absorbable implants and the development of wound infection. Of the 2500 patients 2044 were trauma patients and 456 were operated on for orthopedic disease. In 1466 patients treated with implants made of self-reinforced polyglycolic acid (SR-PGA) only, the patients who developed wound infection had a higher implant volume (P=0.07) than those who did not; this difference was close to statistical significance. In the 446 patients who received only implants made of self-reinforced poly-l-lactic acid (SR-PLLA), the 5 who developed wound infection had a mean implant volume more than three times that of the non-infected patients (P=0.01). We found that in the patients treated with the earlier SR-PGA implants, which contained a green staining material, there was no correlation between implant volume and incidence of wound infections. On the other hand, both the non-stained SR-PGA implants, which have been in clinical use since 1989, and the SR-PLLA implants, seem to be more predictable in terms of wound infections. We believe that this difference, is largely due to the lower level of tissue reactions with these newer implants.     

Chest Wall Implants: Their Use for Pectus Excavatum,Pectoralis Muscle Tears,Poland's Syndrome,and Muscular Insufficiency

Solid customized and prefabricated silicone implants have been used by the author for 15 years in a wide range of chest wall deformities. Chest wall implants are often used in males seeking to augment a muscularly deficient or underdeveloped chest; however, their greatest use has come in a variety of deformities both congenital and acquired, such as pectus excavatum, Poland's Syndrome, and pectoralis muscle tears. The implants can be either customized using a moulage technique or are prefabricated, manufactured implants which can be modified on the operating table to repair the contour deformity. The immediate postoperative problem of seroma and subcutaneous implant ``show' has been minimized by careful planning, gentle technique, deep insertion, improved patient positioning on the operating room table, and the use of oral anti-inflammatory medications. The long-term results of these implants seem very satisfactory. The patients are usualy physically active, and the implants show no long-term sequelae such as seroma, infection, displacement, or rupture.     

Immediate,non-submerged,root-analogue direct laser metal sintering (DLMS) implants: a 1-year prospective study on 15 patients

This study evaluated the 1-year survival and success rate of root-analogue direct laser metal sintering (DLMS) implants, placed into the extraction sockets of 15 patients. DLMS is a technology which allows solids with complex geometry to be fabricated by annealing metal powder microparticles in a focused laser beam, according to a computer-generated three-dimensional (3D) model; the fabrication process involves the laser-induced fusion of titanium microparticles, in order to build, layer-by-layer, the desired object. Cone-beam computed tomography (CBCT) acquisition and 3D image conversion, combined with the DLMS process, allow the fabrication of custom-made, root-analogue implants (RAIs). CBCT images of 15 non-restorable premolars (eight maxilla; seven mandible) were acquired and transformed into 3D models: from these, custom-made, root-analogue DLMS implants with integral abutment were fabricated. Immediately after tooth extraction, the RAIs were placed in the sockets and restored with a single crown. One year after implant placement, clinical and radiographic parameters were assessed: success criteria included absence of pain, suppuration, and exudation; absence of implant mobility and absence of continuous peri-implant radiolucency; distance between the implant shoulder and the first visible bone-to-implant contact <1.5 mm from initial surgery; and absence of prosthetic complications. At the 1-year follow-up, no implants were lost, for a survival rate of 100 %. All implants were stable, with no signs of infection. The good conditions of the peri-implant tissues were confirmed by the radiographic examination, with a mean DIB of 0.7 mm (±0.2). The possibility of fabricating custom-made, RAI DLMS implants opens new interesting horizons for immediate placement of dental implants.     

Effects of hexose sugars: glucose, fructose, galactose and mannose on wound healing in the rat

The effects of four hexose sugars (D-glucose, D-fructose, D-galactose, D-mannose) on the developing granulation tissue in rats were examined. Cylindrical hollow sponge implants were used as an inductive matrix for the growth of granulation tissue. In the test group, the implants were injected with 0.1 ml of solution containing the different hexoses in 0.01, 0.1 and 1 M concentrations daily for 7 days while the implants of the control groups were injected with 0.1 ml of phosphate-buffered saline solution only. Analyses of granulation tissue and wound fluid in the sponge implants were carried out 7 days after implantation. The results demonstrated that galactose caused a significant increase in the accumulation of granulation tissue as estimated by histological analyses, but no significant differences were observed in various chemical analyses. In striking contrast, statistically significant decreases were observed in the number of leukocytes in wound fluid, in the amount of DNA, RNA, collagen hydroxyproline, nitrogen, hexosamines and uronic acids in sponges treated with 0.1 or 1 M mannose, reflecting decreased granulation tissue formation. This effect was also observed in histological analyses of the specimens. There were no major changes in sponges treated with glucose or fructose. In summary, the findings of the present study demonstrate that galactose may enhance wound healing and mannose treatment inhibits the inflammatory reaction in wound healing and decreases granulation tissue formation in an experimental wound model.     

Porous tantalum implant in early osteonecrosis of the hip: preliminary report on operative, survival, and outcomes results

Porous tantalum implants are used in early osteonecrosis of the hip. Device evaluation included surgical time, blood loss, hospitalization, patient-controlled analgesia use, transfusions, implant survival, and outcomes. Mean blood loss was 70 mL. Mean operative time was 36 minutes. Average hospitalization was less than 1 day. No patient required patient-controlled analgesia use or transfusions. Results were compared to a historical vascularized fibular graft population. All parameters were less than the fibular graft groups (P < .00001). All surviving implants (86%) resulted in good to excellent outcomes. Kaplan-Meier analysis at 39 months was 86% and 67% for the implant and fibular graft, respectively (P = .21). Early outcomes demonstrate that porous tantalum implants are a safe option for femoral head salvage. Continued follow-up is necessary to determine the long-term success.     

The classification of implants: class I, II, III

Medical implants fall under the larger category of medical devices, which are defined as products used for medical purposes in patients, in diagnosis and/or treatment. There are three classes of devices that are controlled by the Food and Drug Administration (FDA). Class I devices present the lowest safety risk and are only subject to general controls; Class II devices require general and special controls involving labeling requirements, mandatory performance standards and adequate surveillance; Class III devices must have the same general and special controls as Class I and II devices, and undergo scientific review. Class III is the most scientifically rigorous classification of medical devices and encompasses most of the orthopedic implants on the market today. In this paper, different categories of orthopedic implants will be discussed, including the development of artificial anterior cruciate ligament (ACL) grafts and FDA approval of alumina ceramic-on-ceramic (COC) total hip prostheses.     

Tissue response to polyglycolide, polydioxanone, polylevolactide, and metallic pins in cancellous bone: An experimental study on rabbits.

The purpose of this study was to investigate, qualitatively and histoquantitatively, the tissue response of rabbit femur cancellous bone to polyglycolide (PGA), polydioxanone (PDS), polylevolactide (PLLA), and stainless steel pins under identical conditions. Eighty knees in 50 rabbits were operated on by inserting bioabsorbable pins (PGA, PDS, or PLLA) together with metallic Kirschner wire in 60, and two metallic Kirschner wires alone in 20 knees, while 20 knees served as intact controls. Follow-up times were 3, 6, 12, 24, and 52 weeks. Cancellous bone tissue response to implants was studied using histological, histomorphometrical, microradiographical, and oxytetracycline fluorescence methods. Residual fragments of PGA and PDS were seen at 24 weeks. Complete degradation of these polymers had taken place before 52 weeks. No signs of degradation of the PLLA pins were observed within the entire follow-up period. The osteoid formation surfaces at tissue implant-interface were statistically larger in all test groups as compared to intact controls. The number of macrophages at tissue implant-interfaces increased in all bioabsorbable implant specimens until 6 weeks, and with PGA until 12 weeks. No differences in the osseous response emerged when comparing groups of bioabsorbable implants with each other or with stainless steel group. Bioabsorbable pins and metallic Kirschner wires evoked an osteoconductive response in the cancellous bone surrounding implant, but the response intensity between implants displayed no differences. This suggests a simple, nonspecific walling-off new-bone front type of response. Consequently, the polymers possessed no specific osteostimulatory or osteoinhibitory properties. Within the follow-up, no significant differences in biocompatibility between the implants appeared, and no frank inflammatory foreign-body reactions occurred. The small-volume pins obviously did not exceed the local tissue tolerance and clearing capacity of the bone.     

Custom Implants in TKA Provide No Substantial Benefit in Terms of Outcome Scores,Reoperation Risk,or Mean Alignment: A Systematic Review

BackgroundFailure to accurately replicate the native anatomy and biomechanics of the knee has been suggested to contribute to dissatisfaction after TKA. Custom implants promise a personalized surgical approach, with the aim of improving patient satisfaction and pain as well as lowering revision rates. However, some published research on custom TKA implants has found no clinically important improvements in postoperative validated outcomes scores, risks of revision or reoperation, and implant alignment. In the interest of helping to settle this controversy, a systematic review seems warranted.Question/purposeIn this systematic review, we asked whether custom implants result in clinically important improvements over conventional off-the-shelf implants for anatomically uncomplicated primary TKA in terms of (1) validated outcomes scores, (2) the risk of revision or reoperation, and (3) implant alignment.MethodsThe US National Library of Medicine (PubMed/Medline), Embase, Web of Science, and Cochrane Database of Systematic Reviews were systematically searched to identify publications from the past 10 years relevant to this review. Publications that compared the clinical outcome measures, number of revisions and reoperations, and radiological assessment of implant alignment of custom and standard implants with validated endpoints were eligible for inclusion. In the interest of capturing as much potentially relevant information as possible, we applied no requirement for minimum follow-up duration. Clinical outcomes were assessed using patient-reported outcome (PROM) scores including the Knee Society Score (KSS), Forgotten Joint Score, and Knee Injury and Osteoarthritis Outcome Score. The risk for revision or reoperation were evaluated by the number of early and late manipulations, debridement procedures, and replacement of one or more components. Implant alignment was compared using postoperative deviation from the neutral (0°) mechanical axis of the limb and each component and the posterior tibial slope. All qualified studies were retrospective, and all compared custom implants with standard implants. Data on 1510 patients were reviewed (749 with custom implants and 761 with off-the-shelf implants). The mean follow-up time ranged from 12 to 33 months.ResultsThere was no apparent advantage to custom implants in terms of PROM scores. Of the five studies evaluating clinical outcomes, only one reported better KSS-Function scores at 3 months; two reported no difference, and two found inferior KSS scores. In several studies, custom implants were associated with more frequent reoperations than standard implants. Although in general there were no differences between custom and standard implants in terms of mean coronal plane limb alignment, one of seven studies found that the proportion of patients whose alignment was outside ± 3° from the neutral axis in the coronal plane was lower in the custom group than in the standard group.ConclusionWith generally poorer outcomes scores for pain and function, generally higher risks of reoperation and reintervention, and no overall benefit to alignment, custom implants for primary TKA for the general population currently appear to be inferior to standard implants. Whether the slight reduction in the proportion of patients with alignment outliers observed in a minority of studies will result in a substantial reduction in revision risk over time must be addressed by future studies. However, until or unless such a reduction is proven, we recommend against the routine use of custom implants in practice because of increased costs and the risks associated with their novelty.Level of EvidenceLevel III, therapeutic study.     

Expanded polytetrafluoroethylene implants in rhinoplasty: literature review, operative techniques, and outcome

Gore-Tex, a form of expanded polytetrafluoroethylene (ePTFE), over the past 30 years has attracted much attention as an alloplast for use in rhinoplasty, both from advocates and opponents of its use. It has many desirable traits as an alloplast implant, but many surgeons harbor hesitation and reluctance for alloplast use in rhinoplasty based on historical data of previous nasal implants. Only when objective data from large series of patients with long-term follow-up become available will such skepticism be resolved. Large series of patients with Gore-Tex implant placement during rhinoplasty are beginning to emerge in the literature. The purpose of this article is twofold. The first is to provide the reader with an up-to-date review of the literature on the host response to polymer implants and, second, of the current indications and operative techniques for use and outcomes of Gore-Tex implants in rhinoplasty.     

Injectable dextranomer-based implant: histopathology, volume changes and DNA-analysis

OBJECTIVE: To study the tissue reaction in and around the implant, the changes in implant volume and the DNA profile of the invading cells when a new substance, dextranomers in sodium hyaluronan solution (DiHA), was injected into experimental animals. MATERIALS AND METHODS: Nine pigs were followed up from 2 weeks to 3.5 months and 34 rats were followed up from 3 weeks to 16 months after injection of DiHA into the bladder in pigs and into the subcutaneous tissue in rats. Histopathological analysis was performed in 16 pig and 63 rat implants. In 31 of the rat implants the DNA profile was analysed. Changes in implant volume over time were estimated in 51 rat implants during the period up to 12 months after implantation. RESULTS: Histologically, in the early phases the area within and around the implant was fairly rich in cells, predominantly fibroblasts, inflammatory cells and giant cells of the foreign body type. Later in the process an increase in extracellular matrix around the microspheres and ingrowth of blood vessels was seen. No tissue necrosis or significant eosinophilia was observed around the implants. DNA measurements by flow cytometry revealed no aneuploid cells. There was a decrease in implant volume by 23% over a period of 12 months. CONCLUSIONS: DiHA does not induce any major tissue changes in and around the implants. No DNA changes were observed during the study period of 16 months. DiHA seem to be a safe and suitable injectable substance with good tissue-augmenting properties.     

Articulating choices in total hip arthroplasty: Why’s,wherefores, and caveats

Over the last several decades, our understanding of total hip arthroplasty (THA) tribology (friction, lubrication, wear, and the design of bearings) has evolved tremendously. Overall, THA implants and bearing surfaces are improving and with current generation highly cross-linked polyethylene (HXLPE), it is expected that the longevity of THA will be unprecedented. Bearings surface usage varies significantly by region, but today the North American market is heavily dominated by cobalt chrome or ceramic on HXLPE. There has also been a dramatic decline in the number of metal-on-metal THAs being used due to the large (and growing) number of controversies surrounding these implants. Nevertheless, as trends in THA bearing surfaces change, one thing will always remain constant: meticulous surgical technique is critical to the success and durability of these implants.     

Unilateral Osmotic Swelling in Textured,Single-Lumen,Saline-Filled Mammary Implants: Clinical and MRI Findings

An odd complication following routine breast augmentations was observed in two patients. Single-lumen, textured, high-profile, saline-filled mammary implants were placed in the submuscular plane and postoperative course was uneventful in the presented cases. Unilateral, gradual, and spontaneous swelling in one of the operated breasts was observed 6–14 months after surgery that prompted patients for examination. MRI showed regular external contours of the mammary implants without any evidence of rupture or extracapsular leakage. However, a substantially volumetric increase in the auto-inflated implant was noted since transverse diameter of the right breast implant was twice the left normal implant. All cases had to be re-operated and implants were explanted. Auto-inflated implants were checked and were found to be intact. Intraoperative findings included swelling of the implant and brown discoloration of the previously-transparent saline solution. Furthermore, composition of the fluid inside the expanded implant was found to have changed, possibly through an osmotic gradient. Several mechanisms such as osmotic swelling, defect at the valvular system of the implant, and inorganic salts yielded from texturization process in the shell are suggested but further research with more refined techniques should be done. The present study provides supplementary MRI and confirmatory clinical findings on this bizarre phenomenon and other factors apart from the disruption of the implant integrity may play a role.     

Long-term biologic fate of neoarteries regenerated in microporous, compliant, biodegradable, small-caliber vascular grafts in rats

Microporous, compliant, biodegradable vascular grafts prepared from a mixture of polyurethane [( PU], 95% weight) and poly-L-lactide [( PLLA] 5% weight) can function as temporary scaffolds for the regeneration of the arterial wall of small-caliber arteries. The purpose of this study was to determine the long-term biologic fate of these neoarteries that were regenerated in PU/PLLA vascular grafts. The PU/PLLA vascular grafts (1.5 mm internal diameter [ID]) were implanted into the abdominal aortas of rats (N = 8) and were evaluated 1 year after implantation by means of macroscopic inspection, light microscopy, and electron microscopy. All implants were patent; three implants were normally shaped, two were slightly dilated (+/- 10% of the original ID), and three implants were aneurysmal. Arterial pulsations were reduced but still visible in the normally shaped implants and absent in the other implants. In all implants, the neointima was complete. The neomedia varied among the implants: In the normally shaped implants, smooth muscle cells were predominantly circularly arranged as in normal arterial tissue; in the other implants, smooth muscle cells were predominantly longitudinally arranged. The neoadventitia showed a completely fragmented graft lattice, which was organized by fibrohistiocytic tissue. These results suggest that the pattern of arrangement of smooth muscle cells in the neomedia determines the ultimate biologic fate of neoarteries regenerated in microporous, compliant, biodegradable vascular grafts. Only those neoarteries with predominantly circularly arranged smooth muscle cells in the neomedia were able to function normally as an arterial substitute for a 1-year period after implantation into the rat abdominal aorta.     

Augmentation mammoplasty: effect on diagnosis of breast cancer.

Breast augmentation for cosmetic purposes is an increasingly common procedure in the USA and UK. In the USA in 2003, a total of 254 140 breast augmentation procedures were carried out [American Society of Plastic Surgeons, http://www.plasticsurgery.org/news_room/Procedural-Statistics-Press-Kit-Index.cfm9-1-2005; 2006.(1)]. It has been previously estimated that between 1 and 1.5 million women in the USA have prosthetic breast implants [Cook RR, Delongchamp RR, Woodbury M, et al. The prevalence of women with breast implants in the United States, 1989. J Clin Epidemiol 1995;48:519-25.(2)]. The UK National Breast Implant Registry has recorded a rise in the numbers of women receiving breast implants, with over 13 000 procedures registered in 2001; an estimated 77% of these were for cosmetic purposes. No association has been found between the presence of breast implants in a breast and an increased risk of breast cancer, and this subject has been comprehensively reviewed elsewhere [Hoshaw SJ, Klein PJ, Clark BD, et al. Breast implants and cancer: causation, delayed detection, and survival. Plast Reconstr Surg 2001;107:1393-407.(3)]. However, as the population of women with breast implants ages, an increasing number of them will develop breast cancer; a reflection of the fact that the incidence of the disease increases with increasing age. Debate continues on the effect of breast implants on the efficacy of mammography in diagnosing breast cancer, and the role of other imaging techniques for this purpose, as well as the limitations that the presence of implants place on percutaneous biopsy techniques. We review the literature on the radiological and tissue diagnosis of breast cancer in women with a history of previous augmentation mammaplasty.     

Programmatic effectiveness of a university-based implant training program: long-term, patient-centered outcomes

The University of Kentucky College of Dentistry established a formal implant program in 1999. The program utilizes a single system (Straumann) and a team concept in which implants are placed by residents in period ontology or oral and maxillofacial surgery and restored by predoctoral dental students. The program features stringent patient inclusion and exclusion criteria, incremental structured learning experiences, formal standardized protocols, and hands-on preclinical learning experiences. The use of a single system simplified training protocols and inventory requirements. Complete and partially edentulous patients requiring single and multiple implants are eligible for the program, although maxillary anterior sites are excluded. There is a formal quality assurance program to assess patient-centered outcomes. The current report includes data for patients who had implants placed in the period from January 2000 through December 2002. During that period, 192 patients received dental implants, of which 116 patients (248 implants) were available for analysis. The mean follow-up was 7.05 years (median = 7.32 years). The implant survival rate was 98.4%, while the success rate was 93.15%. Success was determined by the absence of pain or mobility, as well as self-reported patient satisfaction with function, appearance, and surgical experience.     

Editorial Commentary: New Kid on the Block: Rotator Cuff Patch Augmentation Requires Rigorous Scrutiny

There is still plenty of room for improvement in surgical rotator cuff repair healing as well as in nonsurgical cases. Adding an implant or patch to improve results has been a subject of much discussion for a couple of decades. The main problem has been that the surgical procedures are so difficult, with added time and its effect, and therefore are controversial. Many surgeons are reluctant to go the surgical route. As we have advanced technically, we are at a turning point, with newer implants that can be easily augmented. Therefore, recently many surgeons have been using implants, and preliminary reports seem promising. New implants must withstand vigorous challenges, and future extensive and long-term studies can enable improved implants using human tissue.     

The effect of Er:YAG laser irradiation on hydroxyapatite-coated implants and fluoride-modified TiO2-blasted implant surfaces: a microstructural analysis

The purpose of this study was to evaluate the microscopic changes and surface roughness on hydroxyapatite (HA)-coated implants following exposure to different powers and durations of Er:YAG laser irradiation in order to determine the proper pulse energy level and irradiation time. Ten HA-coated implants and ten fluoride-modified TiO₂ implants were used. The implants were divided into a control (one implant) and test group (nine implants) for each implant type. Implants in the test groups were sub-divided into three groups (three implants per group) based on the applied laser pulse energy and irradiation time. The measurement of surface roughness was performed on all implants in the test groups using a white light interferometer before and after laser irradiation. R _a values were recorded and compared in order to evaluate changes in surface roughness. For HA-coated implants, the R _a values increased in all test groups after laser irradiation. However, mean R _a values in the fluoride-modified TiO₂-blasted implant test group were decreased after irradiation. There was no statistical difference. Scanning electron microscope analysis revealed surface alterations in both the HA-coated and fluoridated TiO₂-blasted implants irradiated for 1.5 min at 100 mJ/pulse, 10 Hz. When the pulse energy and irradiation time increased, greater surface alterations, including surface flattening and microfractures, were observed. In conclusion, the results of the current study suggest that no changes could be observed in both HA-coated implants and fluoride-modified TiO₂-blasted implants after irradiation at an intensity of 100 mJ/pulse, 10 Hz for 1 min performed to achieve surface detoxification.     

Metallic neurosurgical implants for cranial reconstruction and fixation: assessment of magnetic field interactions, heating and artefacts at 3.0 Tesla

The objective of this study was to evaluate the magnetic resonance imaging (MRI) compatibility of metallic neurosurgical implants commonly used for cranial reconstruction and fixation, in association with a 3.0 Tesla (T) MR system. Ten metallic neurosurgical implants used for cranioplasty operations were evaluated. The implants were tested ex vivo for magnetic field interactions (translational attraction and torque), heating (using saline and gel phantoms), and artefact production [using dual echo spin echo (DSE) and gradient echo (GRE) sequences] at 3.0 Tesla. None of the implants displayed translational attraction or torque, and heating was physiologically insignificant (maximal temperature elevation was 0.5 degrees C). MR artefacts were minimal with spin echo sequences; gradient echo sequences produced much larger artefacts. The neurosurgical implants evaluated in this study should not present a risk to patients undergoing MRI in the 3.0 T MR system. Although the implants do produce susceptibility artefacts, especially with gradient echo sequences, useful imaging should still be possible.