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
In a consecutive retrospective analysis of 190 patients treated with the Masquelet technique at the BG Klinikum Hamburg from January 2012 to January 2022, defect-specific features such as the extent and morphology of the defect were recorded, and their influence on the time to reach full weight-bearing of the affected limb was investigated. A total of 217 defects were treated in 190 patients using the Masquelet technique. 70% of all defects were located in the tibia, followed by 22% in the femur and only about 7% in the upper extremity. The average length of all defects was 58 mm (+/−31 mm), with the largest defect measuring 180 mm and the smallest measuring 20 mm. 89% of the patients achieved full weight-bearing at the end of therapy. The average time from initiation of therapy to reaching safe full weight-bearing was 589 days. There was a significant correlation between defect length and time to reach full weight-bearing (p = 0.0134). These results could serve as a basis for creating a score for prognostics and evaluation of bone healing after treatment with the Masquelet technique. Additionally, the results could help guide indications for secondary stabilization using internal fixation.
The monitoring of fracture healing is a complex process. Typically, successive radiographs are performed and an emerging calcification of the fracture area is evaluated. The aim of this study was to investigate whether different bone healing patterns can be distinguished using a telemetric instrumented femoral internal plate fixator. An electronic telemetric system was developed to assess bone healing mechanically. The system consists of a telemetry module which is applied to an internal locking plate fixator, an external reader device, a sensor for measuring externally applied load and a laptop computer with processing software. By correlation between externally applied load and load measured in the implant, the elasticity of the osteosynthesis is calculated. The elasticity decreases with ongoing consolidation of a fracture or nonunion and is an appropriate parameter for the course of bone healing. At our centre, clinical application has been performed in 56 patients suffering nonunion or fracture of the femur.Objectives
Materials and Methods
In an interdisciplinary project involving electronic
engineers and clinicians, a telemetric system was developed to measure
the bending load in a titanium internal femoral fixator. As this
was a new device, the main question posed was: what clinically relevant
information could be drawn from its application? As a first clinical
investigation, 27 patients (24 men, three women) with a mean age
of 38.4 years (19 to 66) with femoral nonunions were treated using the
system. The mean duration of the nonunion was 15.4 months (5 to
69). The elasticity of the plate-callus system was measured telemetrically
until union. Conventional radiographs and a CT scan at 12 weeks
were performed routinely, and healing was staged according to the
CT scans. All nonunions healed at a mean of 21.5 weeks (13 to 37).
Well before any radiological signs of healing could be detected,
a substantial decrease in elasticity was recorded. The relative
elasticity decreased to 50% at a mean of 7.8 weeks (3.5 to 13) and
to 10% at a mean of 19.3 weeks (4.5 to 37). At 12 weeks the mean
relative elasticity was 28.1% (0% to 56%). The relative elasticity
was significantly different between the different healing stages
as determined by the CT scans. Incorporating load measuring electronics into implants is a promising
option for the assessment of bone healing. Future application might
lead to a reduction in the need for exposure to ionising radiation
to monitor fracture healing.