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No clinical advantage with customized individually made implants over conventional off-the-shelf implants in total knee arthroplasty: a systematic review and meta-analysisIntroduction: Total knee arthroplasty (TKA) can be performed with either conventional off-the-shelf (OTS) or customized individually-made (CIM) implants. The evidence for CIM implants is limited and variable, and the aim of this review was to compare clinical and radiological outcomes between CIM and OTS implants. Methods: A systematic review and meta-analysis were conducted in accordance with PRISMA guidelines. Studies reporting on clinical, radiological, or alignment outcomes for CIM and OTS implants were selected. The studies were appraised using the Methodical index for non-randomized studies tool. Results: Twenty-three studies fulfilled the inclusion criteria. The studies comprised 2856 CIM and 1877 OTS TKAs. Revision rate was higher with CIM (5.9%) compared to OTS (3.7%) implants [OR 1.23(95% CI 0.69-2.18)]. Manipulation under anesthesia (MUA) was higher in CIM (2.2%) compared to OTS (1.1%) group [OR 2.95(95% CI 0.95-9.13)] and complications rate was higher in CIM (5%) vs. OTS (4.5%) [OR 1.45(95% CI 0.53-3.96)] but neither reached statistical significance. Length of stay was significantly shorter in CIM group 2.9 days vs. 3.5 days [MD - 0.51(95% CI - 0.82 to - 0.20)]. Knee Society Score showed no difference between CIM and OTS groups for Knee 90.5 vs. 90.6 [MD - 0.27(95% CI - 4.27 to 3.73)] and Function 86.1 vs. 83.1 [MD 1.51(95% CI - 3.69 to 6.70)]. Conclusion: CIM implants in TKA have theoretical benefits over OTS prostheses. However, in this present review, CIM implants were associated with higher revisions, MUA, and overall complication rates. There was no difference in outcome score and CIM implants did not improve overall target alignment; however, more CIM TKAs were found to be in the HKA target zone compared to OTS TKAs. The findings of this review do not support the general utilization of CIM over OTS implants in TKA.
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The Use of Interlocking Polyetheretherketone Patient-Specific Facial Implants in the Treatment of Facial Deformities. A Retrospective Review of Ten PatientsPurpose: Polyetheretherketone (PEEK) is a versatile biocompatible material with a wide variety of clinical applications. Multiple-piece 3-dimensionally milled interlocking PEEK patient-specific implants are used in cases with restricted access or around vital structures. The interlocking joints reduce the number of fixation screws required by converting the multiple segments into one single implant. Stability of such joints is of paramount importance to prevent complications such as infection and implant extrusion. This retrospective study evaluates the clinical outcomes in the use of multiple-piece 3-dimensionally milled interlocking PEEK patient-specific implants as a treatment for various congenital and acquired facial deformities. Methods: Patients' records and clinical interviews were retrospectively reviewed. Results: A total of 10 patients were included; 6 of them (60%) were men. A planning cone beam scan (90%) or computed tomography scan (10%) were obtained following a standard protocol. All treatments were performed by a single surgeon, following a standardized approach. The follow-up time ranged from 11 to 61 months (mean = 37.1 months), No implant exposure, extrusion or removal were reported. Three patients (30%) have experienced complications. Recurrent edema was observed in 1 patient (10%), another patient (10%) experienced bilateral mental nerve paresthesia, and the third patient (10%) had recurrent sinusitis, which was successfully treated with functional endoscopic sinus surgery without removing the implant. Conclusion: Within the limitation of this study, 3-dimensionally milled interlocking PEEK patient-specific implants are safe, predictable, potentially save operative time, and readily adjustable. Extra stability and antislippage mechanism can be achieved by using the interlocking joint. Further studies on a larger cohort of patients is needed to confirm these results.
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Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL): an overview of presentation and pathogenesis and guidelines for pathological diagnosis and management.AIMS: Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is an uncommon complication associated largely with textured implants. It is important that the symptoms associated with BIA-ALCL are recognised and that robust pathways are in place to establish the diagnosis. The aim of this paper is to review what is known of the incidence of the disease, current thoughts on pathogenesis, patterns of presentation and pathological features to provide standard guidelines for its diagnosis. METHODS AND RESULTS: Systematic review of the literature via PubMed covering cases series, modes of presentation, cytological, histological and immunohistochemical features and disease outcome. Since 1997, 518 cases throughout 25 countries have been registered on the American Society of Plastic Surgeons PROFILE registry, with an estimated risk for women with an implant of one to three per million per year. It most frequently presents as a late-onset accumulation of seroma fluid, sometimes as a mass lesion. The neoplastic cells are highly atypical, consistently strongly positive for CD30, with 43-90% also positive for EMA, and all are ALK-negative. Behaviour is best predicted using a staging system for solid tumours. CONCLUSION: BIA-ALCL is a rare but important complication of breast implants. While characterised by CD30-positive neoplastic cells this must be interpreted with care, and we provide pathological guidelines for the robust diagnosis of this lesion as well as the most appropriate staging system and management strategies. Finally, in order to generate more accurate data on incidence, we recommend mechanisms for the routine central reporting of all cases.