Pedobarographic evaluation of five commonly used orthoses for the lower extremity.

INTRODUCTION: Orthoses are designed to achieve immobilization or off-loading of certain regions of the foot. Yet, their off-loading capacity for the specific regions has not yet been studied. Therefore, the aim of this study was to analyze the plantar pressure distribution of five commonly applied orthoses for foot and ankle in a healthy population. MATERIALS AND METHODS: Five orthoses (postoperative shoe, forefoot relief shoe, short walker boot, high walker boot, and calcaneus fracture orthosis) were compared pedobarographically using insoles on a treadmill to a ready-made running shoe in eleven healthy subjects (median age 29 years). Peak pressure, maximum force, force-time integral, contact time, and contact area were evaluated separately for the forefoot, midfoot, and hindfoot. RESULTS: The forefoot relief shoe, the short- and high walker boot significantly reduced the peak pressure at the forefoot with no significant differences between these orthoses. None of the five orthoses off-loaded the midfoot, but the calcaneus fracture orthosis and the short walker boot instead increased midfoot load. For the hindfoot, the calcaneus fracture orthosis was the only device to significantly reduce the peak pressure. CONCLUSIONS: This is the first study to investigate the specific off-loading capacities of different orthoses for specific foot regions in a healthy collective. The knowledge of absolute and relative load shifts for the different orthoses is of fundamental interest for targeted clinical decision-making of physicians.

Functional outcomes before and after implant removal in patients with posttraumatic shoulder stiffness and healed proximal humerus fractures: does implant material (PEEK vs. titanium) have an impact? - a pilot study.

BACKGROUND: Posttraumatic shoulder stiffness remains a problem after proximal humerus fracture (PHF) despite good healing rates. The aim of this pilot study was to determine whether the implant material and overlying soft tissue have an effect on shoulder range of motion (ROM) before and after implant removal (IR). METHODS: 16 patients (mean age 55.2 ± 15.3 (SD) years; 62.5% female) were included who underwent operative treatment with locking plates of either carbon fiber reinforced Polyetheretherketone (PEEK) (PEEKPower® humeral fracture plate, Arthrex, Naples, Florida, USA, n = 8) or titanium alloy (Ti) (Philos®, DePuy Synthes, Johnson & Johnson Medical, Raynham, Massachusetts, USA, n = 8) for PHF. All patients presented with a limited ROM and persistent pain in everyday life after the fracture had healed, whereupon IR was indicated. ROM before and after IR were compared as well as the Constant Score (CS) and the CS compared to the contralateral shoulder (%CS) 1 year after IR. RESULTS: In group PEEK, elevation was 116.3° ± 19.2° pre- and 129.4° ± 23.7° post-IR (p = 0.027). External rotation was 35.0° ± 7.6° pre- and 50.6° ± 21.8° post-IR (p = 0.041). External rotation with the humerus abducted 90° was 38.8° ± 18.1° pre- and 52.5° ± 25.5° post-IR (p = 0.024). In group Ti, elevation was 110.0° ± 34.6° pre- and 133.8° ± 31.1° post-IR (p = 0.011). External rotation with the humerus at rest was 33.8° ± 23.1° pre- and 48.8° ± 18.7° post-IR (p = 0.048). External rotation with the humerus abducted 90° was 40.0° ± 31.6° pre- and 52.5° ± 22.5° post-IR (p = 0.011). Comparison of the two implant materials showed no significant difference. The overall CS was 90.3 ± 8.8, the %CS was 91.8% ± 14.7%. CONCLUSION: There was no significant difference in ROM, CS and %CS with respect to plate materials, although lower cell adhesion is reported for the hydrophobic PEEK. However, all patients showed improved functional outcomes after IR in this pilot study. In patients with shoulder stiffness following locked plating for PHF, implants should be removed and open arthrolysis should be performed, independently from the hardware material. LEVEL OF EVIDENCE: II.

Inflammatory tissue response in human soft tissue is caused by a higher particle load near carbon fiber-reinforced PEEK compared to titanium plates.

Titanium as the leading implant material in locked plating is challenged by polymers such as carbon fiber-reinforced polyetheretherketone (CFR-PEEK), which became the focus of interest of researchers and manufacturers in recent years. However, data on human tissue response to these new implant materials are rare. Osteosynthesis plates and peri­implant soft tissue samples of 16 healed proximal humerus fractures were examined (n = 8 CFR-PEEK, n = 8 titanium). Soft tissue was analyzed by immunohistochemistry and µCT. The entrapped foreign bodies were further examined for their material composition by FTIR. To gain insight into their origin and formation mechanism, explanted and new plates were evaluated by SEM, EDX, profilometry and HR-CT. In the peri­implant soft tissue of the CFR-PEEK plates, an inflammatory tissue reaction was detected. Tissues contained foreign bodies, which could be identified as tantalum wires, carbon fiber fragments and PEEK particles. Titanium particles were also found in the peri­implant soft tissue of the titanium plates but showed a less intense surrounding tissue inflammation in immunohistochemistry. The surface of explanted CFR-PEEK plates was rougher and showed exposed and broken carbon fibers as well as protruding and deformed tantalum wires, especially in used screw holes, whereas scratches were identified on the titanium plate surfaces. Particles were present in the peri­implant soft tissue neighboring both implant materials and could be clearly assigned to the plate material. Particles from both plate materials caused detectable tissue inflammation, with more inflammatory cells found in soft tissue over CFR-PEEK plates than over titanium plates. STATEMENT OF SIGNIFICANCE: Osteosynthesis plates are ubiquitously used in various medical specialties for the reconstruction of bone fractures and defects and are therefore indispensable for trauma surgeons, ENT specialists and many others. The leading implant material are metals such as titanium, but recently implants made of polymers such as carbon fiber-reinforced polyetheretherketone (CFR-PEEK) have become increasingly popular. However, little is known about human tissue reaction and particle generation related to these new implant types. To clarify this question, 16 osteosynthesis plates (n = 8 titanium and n = 8 CFR-PEEK) and the overlying soft tissue were analyzed regarding particle occurrence and tissue inflammation. Tissue inflammation is clinically relevant for the development of scar tissue, which is discussed to cause movement restrictions and thus contributes significantly to patient outcome.

[Isolation and Characterization of Multipotent Precursor Cells from Murine Adipose Tissue using a Clinically Approved Cell Separation System]. / Isolation und Charakterisierung von multipotenten Vorläuferzellen aus murinem Fettgewebe mithilfe eines klinisch zugelassenen Aufbereitungssystems.

INTRODUCTION: Recent studies underscored the clinical potential of adipose-derived multipotent stem-/precursor cells (ASPCs). One of the main hurdles en route to clinical application was to isolate cells without having to perform expansion cultures outside the OR. A new generation of clinically approved, commercially available cell separation systems claims to provide ASPCs ready for application without further expansion cultures. However, it is unclear if the new systems yield sufficient cells of adequate quality for the use in autologous murine models. The aim of this study was to isolate and characterize adipose-derived precursor cells taken from the inguinal fat pat of wistar rats using InGeneron's clinically approved ARC™-cell separation system. MATERIALS AND METHODS: We isolated cells from the inguinal fat pad of 3 male Wistar rats according to the manufacturer's protocol. In order to reduce the influence of the atmospheric oxygen on the multipotent precursor cells, one half of the cell suspension was cultivated under hypoxia (2% O2) simulating physiological conditions for ASPCs. As a control, the other half of the cells were cultivated under normoxia (21% O2). Cell surface markers CD90, CD29, CD45 and CD11b/c were analyzed by FACS, and osteogenic and adipogenic differentiation of the ASPCs was performed. Finally, cellular growth characteristics were assessed by evaluation of the cumulative population doublings and CFU assay, and metabolic activity was evaluated by WST-1 assay. RESULTS: Processing time was 90 (± 12) min. 1 g of adipose tissue yielded approximately 60 000 plastic adhering cells. Both groups showed a high expression of the mesenchymal stem cell markers CD90 and CD29 while they were negative for the leucocyte markers CD45 and CD11b/c. A strong osteogenic differentiation and a sufficient adipogenic differentiation potential was proven for all ASPCs. Under hypoxia, ASPCs showed increased proliferation characteristics and CFU efficiency as well as a significantly increased metabolic activity. CONCLUSION: This study showed that sufficient multipotent ASPCs of appropriate quality can be isolated from the inguinal fat pad of Wistar rats using the ARC™-cell separation system. As shown in previous studies, cultivation of cells under hypoxic conditions increased their stemness. Our findings will enable future studies that focus on autologous transplantation of ASPCs in a rat model, which most closely resembles a possible clinical application.