Magnesium alloys have recently been rediscovered as biodegradable implants in musculoskeletal surgery. This study is an ex-vivo trial to evaluate the imaging characteristics of magnesium implants in different imaging modalities as compared to conventional metallic implants. A CE-approved magnesium Herbert screw (MAGNEZIX®) and a titanium screw of the same dimensions (3.2x20 mm) were imaged using different modalities: digital radiography (DX), multidetector computed tomography (MDCT), high resolution flat panel CT (FPCT) and magnetic resonance imaging (MRI). The screws were scanned in vitro and after implantation in a fresh chicken tibia in order to simulate surrounding bone and soft tissue. The images were quantitatively evaluated with respect to the overall image quality and the extent and intensity of artifacts. In all modalities, the artifacts generated by the magnesium screw had a lesser extent and were less severe as compared to the titanium screw (mean difference of artifact size of solo scanned screws in DX: 0.7 mm, MDCT: 6.2 mm, FPCT: 5.9 mm and MRI: 4.73 mm; p < 0.05). In MDCT and FPCT multiplanar reformations and 3D reconstructions were superior as compared with the titanium screw and the metal-bone interface after implanting the screws in chicken cadavers was more clearly depicted. While the artifacts of the titanium screw could be effectively reduced using metal-artifact reduction sequences in MRI (WARP, mean reduction of 2.5 mm, p < 0.05), there was no significant difference for the magnesium screw. Magnesium implants generate significantly less artifacts in common imaging modalities (DX, MDCT, FPCT and MRI) as compared with conventional titanium implants and therefore may facilitate post-operative follow-up.

Scaphoid fractures are the most common carpal fractures. They often need to be treated by surgery, where the use of a compression screw is the globally accepted gold standard. Surgeons may choose between different implant materials including titanium alloys, which remain in the body or are removed after healing. An alternative are biodegradable magnesium-based implants. Properties of magnesium alloys include high stability, osteoconductivity, potential reduction of infections and few artifacts in magnetic resonance imaging (MRI). The aim of this trial is to demonstrate non-inferiority of magnesium-based compression screws compared with titanium Herbert screws for scaphoid fractures. The trial is designed as a multicenter, blinded observer, randomized controlled parallel two-group post market trial. Approximately 190 patients will be randomized (1:1) with stratification by center either to titanium or magnesium-based compression screws. Follow-up is 1 year per patient. Surgical procedures and aftercare will be performed according to the German treatment guideline for scaphoid fractures. The first primary endpoint is the patient-rated wrist evaluation (PRWE) score after 6 months. The second primary endpoint is a composite safety endpoint including bone union until 6 months, no adverse device effect (ADE) during surgery or wound healing and no serious ADE or reoperation within 1 year. The third primary endpoint is the difference in change MRI artifacts over time. Non-inferiority will be investigated for primary endpoints 1 (t-test confidence interval) and 2 (Wilson’s score interval) using both the full analysis set (FAS) and the per protocol population at the one-sided 2.5% test-level. Superiority of magnesium over titanium screws will be established using the FAS at the two-sided 5% test-level (Welch test) only if non-inferiority has been established for both primary endpoints. Secondary endpoints include quality of life. This study will inform care providers whether biodegradable magnesium-based implants are non-inferior to standard titanium Herbert screws for the treatment of scaphoid fractures in terms of wrist function and safety. Furthermore, superiority of magnesium-based implants may be demonstrated using MRI, which is used as surrogate endpoint for screw degradation. DRKS, DRKS00013368 . Registered Dec 04, 2017.

Autologous fat grafting represents an attractive source for tissue engineering applications in the field of reconstructive medicine. However, in adipogenic differentiation protocols for human adipose-derived stem cells, the concentration of glucose and insulin varies considerably. With the intent to gain maximum tissue augmentation, we focused on the late phase of adipogenesis. In this study, we modified the differentiation protocol for adipose-derived stem cells by prolongation of the induction period and the application highly concentrated glucose and insulin. Human adipose-derived stem cells were isolated from subcutaneous depots and differentiated in a standard induction medium for the first two weeks, followed by two weeks with varying glucose and insulin concentrations. Morphological changes assessed using Oil-Red-O staining were examined for corresponding alterations in the expression of the adipogenic markers peroxisome proliferator-activated receptor gamma (PPARγ) and lipoprotein lipase (LPL). Furthermore, glucose and lactate levels in conditioned media were monitored over the period of differentiation. We found high-glucose media increasing the level of lipid accumulation and the size of single droplets whereas insulin significantly showed a dose-dependent negative effect on fat storage. However, whereas high glucose stimulated PPARγ transcription, expression levels in insulin-treated cells remained constant. Results permit assumptions that a high-glucose medium intensifies the degree of differentiation in mature adipocytes providing conditions to promote graft volume while we have identified highly concentrated insulin treatment as an inhibitor of lipid storage in the late adipogenic differentiation.