2-year results of middle-aged patients with two-compartment cartilage lesions in one knee treated with two patient specific metal implants.

PURPOSE: Focal chondral lesions of the femur are currently treated with biological repair or arthroplasty. However, some patients are not suitable for either one due to lesion size, age, or prior biological treatment attempts. While singular patient-specific focal mini metal implants already showed good results, the outcomes of bicompartmental implantation of these implants have not been discussed in the literature yet. This study aims to evaluate clinical outcomes of patients who underwent bicompartmental implantation of two patient-specific implants. METHODS: This prospective, non-randomized, non-comparative pilot study evaluates results up to two years after bicompartmental implantation of two implants (Episealer Implant, Episurf, Stockholm, Sweden). A damage report is compiled using a special MRI program and patient specific implants are manufactured, including 3D-printed surgical instruments to provide exact placement of the implant. The patients were assessed repeatedly using the Knee Injury and Osteoarthritis Outcome Score (KOOS) and Visual Analogue Scale (VAS) for pain during the follow-up. RESULTS: The scores were evaluated three, 12, and 24 months after surgery and showed good results. The median in both scores improved from 37.7 for the KOOS5 preoperatively to 69.1 after 24 months and from 69 for the VAS for pain preoperatively to 9 after 24 months. CONCLUSION: Overall, for the small study group presented, the early results are promising. With noticeable improvement in KOOS and VAS for pain after two years, patient specific implants appear to become relevant in future standardized treatment of femoral chondral lesions. Especially with bicompartmental implantation, full arthroplasty can be delayed even further. LEVEL OF EVIDENCE: IV.

Optimizing hepcidin measurement with a proficiency test framework and standardization improvement.

Objectives: Hepcidin measurement advances insights in pathophysiology, diagnosis, and treatment of iron disorders, but requires analytically sound and standardized measurement procedures (MPs). Recent development of a two-level secondary reference material (sRM) for hepcidin assays allows worldwide standardization. However, no proficiency testing (PT) schemes to ensure external quality assurance (EQA) exist and the absence of a high calibrator in the sRM set precludes optimal standardization. Methods: We developed a pilot PT together with the Dutch EQA organization Stichting Kwaliteitsbewaking Medische Laboratoriumdiagnostiek (SKML) that included 16 international hepcidin MPs. The design included 12 human serum samples that allowed us to evaluate accuracy, linearity, precision and standardization potential. We manufactured, value-assigned, and validated a high-level calibrator in a similar manner to the existing low- and middle-level sRM. Results: The pilot PT confirmed logistical feasibility of an annual scheme. Most MPs demonstrated linearity (R2>0.99) and precision (duplicate CV>12.2%), although the need for EQA was shown by large variability in accuracy. The high-level calibrator proved effective, reducing the inter-assay CV from 42.0% (unstandardized) to 14.0%, compared to 17.6% with the two-leveled set. The calibrator passed international homogeneity criteria and was assigned a value of 9.07±0.24 nmol/L. Conclusions: We established a framework for future PT to enable laboratory accreditation, which is essential to ensure quality of hepcidin measurement and its use in patient care. Additionally, we showed optimized standardization is possible by extending the current sRM with a third high calibrator, although international implementation of the sRM is a prerequisite for its success.