Diagnostic accuracy of dual-energy CT and virtual non-calcium techniques to evaluate bone marrow edema in vertebral compression fractures.

PURPOSE: The aim of this study was to evaluate DECT diagnostic accuracy in the identification of vertebral bone marrow edema, using MRI as standard of reference. METHODS: This prospective institutional review board-approved study included 76 consecutive patients (29 males and 47 females; mean age 62.3, range 51-82 years) studied with DECT (90 kV and tin filter 150 kV) and MRI within 7 days. Three radiologists evaluated DECT (reader 1 and 2) and MRI images (reader 3). Diagnostic accuracy of the DECT maps (qualitative assessment) and of the CT numbers (quantitative assessment), interobserver and intraobserver agreements were calculated. RESULTS: MRI revealed 61 edematous vertebrae and 52 collapsed non-edematous vertebrae. The sensitivity, specificity, PPV and NPV and accuracy of the qualitative assessment of the DECT maps were 88.6, 92.3, 93.1, 87.3 and 90.3%, for reader 1, 90.2, 90.3, 91.6, 88.7 and 90.3, for reader 2, and 91.8, 90.4, 91.6, 90.4 and 91.1% for quantitative analysis, respectively. DECT numbers were significantly different between positive (mean - 23 HU, range - 189, 29 HU) and negative cases (mean - 126 HU, range - 321, - 66 HU) with p < 0.001. The ROC curve analysis revealed an AUC of 0.886 (95% confidence interval 0.722-0.913). The interobserver and intraobserver agreements were near perfect (k = 0.87 and k = 0.83, respectively). CONCLUSION: DECT represents an accurate imaging technique for demonstrating bone marrow edema in vertebral compression fracture, if compared to MRI.

A new hydrogel for the conservative treatment of meniscal lesions: a randomized controlled study.

PURPOSE: this study aimed to investigate the efficacy of intra-articular (IA) administration of a hydrogel formulation obtained from a hyaluronic acid (HA) derivative (HYADD4(®)) in the management of meniscal tears and in meniscal tear repair. METHODS: fifty subjects with degenerative meniscal tears were enrolled into this single-site, observer-blind, parallel-group study. Clinical evaluations were performed at baseline and after 14, 30 and 60 days. Clinical outcomes included: pain reduction (Visual Analog Scale), improvement of knee functionality (WOMAC questionnaire), reduction in length and depth of the meniscal lesion (MRI-confirmed) and SF-36 questionnaire scores. Local tolerability and safety were also investigated. RESULTS: a significant reduction in VAS pain (p< 0.001) in favor of HYADD4(®) was recorded at day 14 and maintained at all the follow-up assessments. Data on knee functionality were in line with the VAS pain assessment results. A significant reduction in length and depth of the meniscal lesion, assessed using MRI, was found in the HYADD4(®) group compared to the control group (p<0.001). CONCLUSIONS: the results of this study may indicate a new treatment option in the conservative management of patients complaining of pain due to meniscal tears. The MRI data suggest that the hydrogel formulation of HA used in this study may also play a role in the healing process of the lesion. LEVEL OF EVIDENCE: Level I, prospective randomized clinical trial.

Prospective multi-centre study on a composite ceramic femoral component in total knee arthroplasty: Five-year clinical and radiological outcomes.

BACKGROUND: Enhanced wear resistance of ceramics in general and improved mechanical characteristics of composite ceramics in terms of strength and resistance meet the demands for application in TKA. The aim of this prospective international multi-centre study was to evaluate the 5-year clinical and radiological outcomes of an unconstrained TKA with a composite ceramic femoral component. METHODS: A total of 107 patients (109 knees) underwent TKA with the MULTIGEN-PLUS Ceramic Knee at seven centres in three European countries. Clinical and radiological assessments were performed preoperatively and postoperatively at 3, 12, 24 and 60 months, using HSS, WOMAC, SF-36 and standardised radiographs. RESULTS: Mean HSS and WOMAC increased significantly from 55.1±11.5 (21-83) and 48.1±16.6 (3-90) preoperatively to 85.6±9.6 (49-98) and 73.3±20.4 (17-100) at 60 months. Mean SF-36 showed significant improvements in patients' quality of life (49.1±17.6 (12-96) preoperatively versus 67.7±23.1 (12-100) at 60 months). Non-progressive radiolucent lines (<1 mm) were observed around the femoral component in four cases. Neither implant migration nor loosening were registered. Kaplan-Meier survivorship was 96.0% at 60 months (92.1-100%, CI 95%). CONCLUSIONS: Five-year implant survival rate of the ceramic knee is comparable to other metallic and ceramic unconstrained TKA systems. Although the assessment of long-term implant survivorship is still pending, the ceramic implants represent a promising solution for patients with allergies against metallic components and furthermore for the general osteoarthritis population due to enhanced wear resistance.

Ceramic femoral components in total knee arthroplasty - two year follow-up results of an international prospective multi-centre study.

BACKGROUND: Total knee arthroplasty can be considered as a reliable surgical procedure with a good long-term clinical result. However, implant failure due to particle induced aseptic loosening as well as the aspect of hypersensitivity to metal ions still remains an emerging issue. METHODS: The purpose of this prospective international multi-centre study was to evaluate the clinical and radiological outcomes and the reliability of the unconstrained Multigen Plus Total Knee System with a new BIOLOX® delta ceramic femoral component. Cemented total knee arthroplasty was performed on 108 patients (110 knees) at seven hospitals in three countries. Clinical and radiological evaluations were performed preoperatively, and after 3, 12 and 24 months postoperatively using the HSS-, WOMAC-, SF-36-score and standardised X-rays. RESULTS: The mean preoperative HSS-Score amounted to 55.5 ± 11.5 points and improved significantly in all postoperative evaluations (85.7 ± 11.7 points at 24 months). Furthermore, improvements in WOMAC- and SF-36-score were evaluated as significant at all points of evaluation. Radiolucent lines around the femoral ceramic component at 24 months were found in four cases. Progression of radiolucent lines was not seen and no implant loosening was observed. During the 24 month follow-up eight patients underwent subsequent surgery due to reasons unrelated to the implant material. CONCLUSIONS: The observed clinical and radiological results are encouraging for a long-term survival of the ceramic femoral component. Therefore, ceramic implants could be a promising solution not only for patients with allergies against metallic implant materials, but also for the osteoarthritic knee joint. Long-term follow-up is necessary to draw conclusions regarding the superiority of the ceramic knee implants concerning in vivo wear and long-term survivorship.