Aim of this study was to establish the first clinical results after implantation of ultrathin silver-polysiloxane-coated1 plates in the treatment of infected non-union of the femoral shaft. As part of the REFECT study, a prospective, non-interventional analysis was conducted encompassing all patients who received internal stabilization with a silver-coated1 plate from 01/2023 to 09/2024 as part of the treatment for infected non-union of the femur. Standardized clinical follow-ups including PROMs (WOMAC-Index, LEF-S, EQ-5D, VAS) and X-rays were performed 3, 6, 12 (and 24) months postoperatively. For comparison, a retrospective analysis of 76 patients with infected femoral non-union, who had received a stabilization with an uncoated plate in the past 10 years, was performed.Aim
Method
During the therapy of infected pseudarthrosis and arthrodesis in which multiple autologous bone grafts did not result in osseous consolidation and in delayed osseous healing of transport stretches after completion of segmental transport in osteomyelitis patients without acute infection symptoms, mesenchymal stem cells were added to the treatment. This study demonstrates the mid- and long-term results in different application possibilities with good and poor results. The aim is to develop an algorithm in treating bone defects regarding the different biomaterials and implants that exist on the market. The indication to apply mesenchymal stem cells was the reconstruction of osseous lesions after chronic osteomyelitis, the treatment of pseudarthrosis and the support of osseous growth in segmental transports. Further indications were the absence of adequate amounts of autologous spongiosa, multiple previous operations, risk factors (diabetes, peripheral vascular disease, alcohol and nicotine abuse, etc.) as well as chronic wound healing failure. To obtain the mesenchymal stem cells, we employed two different systems from two companies. Both systems concentrate the mesenchymal stem cells after puncture and aspiration from the pelvic crest. The concentrated stem cells were either mixed with platelet-rich plasma and added to the autologous spongiosa or injected into the area of osseous regeneration after completion of segment transport. Since 2009, we have applied mesenchymal stem cells to 87patients. The treatment was performed in 73 cases of persisting pseudarthrosis after multiple bone grafts and in 14 cases of delayed osseous healing after segmental transport. The results were evaluated by continuous clinical and radiological examinations in our outpatient clinic. We found a great variety in our results with a mainly high rate of survival and healing in the autologous bone grafts with mesenchymal stem cells, resulting predominantly in stabilization of the pseudarthrosis. Furthermore a good osseous consolidation was documented in several cases with transport stretches of segmental transports. However we also had some frustrating results with all the well-known complications of septic surgery. Our experiences so far, have led to a distinguished therapy-algorithm including all the biomaterials and additives that are used in our hospital. Overall, the results demonstrate an advantage in the treatment with mesenchymal stem cells, espe-cially in problematic and difficult cases in combination with multiple pre-existing conditions. The use of mesenchymal stemcells must be included in a general concept regarding all treatment possibilities, it is, however, not a guarantee for successful therapy of osseous lesions after chronic osteomyelitis especially as a single toll mechanism.
