Henning Windhagen

Magnesium hydroxide temporarily enhancing osteoblast activity and decreasing the osteoclast number in peri-implant bone remodelling.

Repeated observations of enhanced bone growth around various degradable magnesium alloys in vivo raise the question: what is the major mutual origin of this biological stimulus? Several possible origins, e.g. the metal surface properties, electrochemical interactions and biological effects of alloying elements, can be excluded by investigating the sole bone response to the purified major corrosion product of all magnesium alloys, magnesium hydroxide (Mg(OH)(2)). Isostatically compressed cylinders of pure Mg(OH)(2) were implanted into rabbit femur condyles for 2-6 weeks. We observed a temporarily increased bone volume (BV/TV) in the vicinity of Mg(OH)(2) at 4 weeks that returned to a level that was equal to the control at 6 weeks. The osteoclast surface (OcS/BS) was significantly reduced during the first four weeks around the Mg(OH)(2) cylinder, while an increase in osteoid surface (OS/BS) was observed at the same time. At 6 weeks, the OcS/BS adjacent to the Mg(OH)(2) cylinder was back within the same range of the control. The mineral apposition rate (MAR) was extensively enhanced until 4 weeks in the Mg(OH)(2) group before matching the control. Thus, the enhanced bone formation and temporarily decreased bone resorption resulted in a higher bone mass around the slowly dissolving Mg(OH)(2) cylinder. These data support the hypothesis that the major corrosion product Mg(OH)(2) from any magnesium alloy is the major origin of the observed enhanced bone growth in vivo. Further studies have to evaluate if the enhanced bone growth is mainly due to the local magnesium ion concentration or the local alkalosis accompanying the Mg(OH)(2) dissolution.

Biodegradable magnesium-based screw clinically equivalent to titanium screw in hallux valgus surgery: short term results of the first prospective, randomized, controlled clinical pilot study

PurposeNondegradable steel-and titanium-based implants are commonly used in orthopedic surgery. Although they provide maximal stability, they are also associated with interference on imaging modalities, may induce stress shielding, and additional explantation procedures may be necessary. Alternatively, degradable polymer implants are mechanically weaker and induce foreign body reactions. Degradable magnesium-based stents are currently being investigated in clinical trials for use in cardiovascular medicine. The magnesium alloy MgYREZr demonstrates good biocompatibility and osteoconductive properties. The aim of this prospective, randomized, clinical pilot trial was to determine if magnesium-based MgYREZr screws are equivalent to standard titanium screws for fixation during chevron osteotomy in patients with a mild hallux valgus.MethodsPatients (n=26) were randomly assigned to undergo osteosynthesis using either titanium or degradable magnesium-based implants of the same design. The 6 month follow-up period included clinical, laboratory, and radiographic assessments.ResultsNo significant differences were found in terms of the American Orthopaedic Foot and Ankle Society (AOFAS) score for hallux, visual analog scale for pain assessment, or range of motion (ROM) of the first metatarsophalangeal joint (MTPJ). No foreign body reactions, osteolysis, or systemic inflammatory reactions were detected. The groups were not significantly different in terms of radiographic or laboratory results.ConclusionThe radiographic and clinical results of this prospective controlled study demonstrate that degradable magnesium-based screws are equivalent to titanium screws for the treatment of mild hallux valgus deformities.

Biodegradable magnesium implants for orthopedic applications

The clinical application of degradable orthopedic magnesium implants is a tangible vision in medical science. This interdisciplinary review discusses many different aspects of magnesium alloys comprising the manufacturing process and the latest research. We present the challenges of the manufacturing process of magnesium implants with the risk of contamination with impurities and its effect on corrosion. Furthermore, this paper provides a summary of the current examination methods used in in vitro and in vivo research of magnesium alloys. The influence of various parameters (most importantly the effect of the corrosive media) in in vitro studies and an overview about the current in vivo research is given.

Influence of a magnesium‐fluoride coating of magnesium‐based implants (MgCa0.8) on degradation in a rabbit model

MgCa0.8 cylinders (2.5 x 25 mm(2)) were coated with a magnesium-fluoride layer and implanted in the marrow cavities of both tibiae of 10 New Zealand White rabbits. The implantation duration was 3 and 6 months. The implants were clinically well tolerated. Micro-computed tomography revealed a new bone formation at the edges of the implants as well as an endosteal and periosteal remodeling. Using EDX-analysis, a calcium and phosphorus rich degradation layer could be found on the implant surface. It was covered by an incomplete layer containing fluoride. The analysis by weight before implantation and after 3 and 6 months, respectively, showed a slight decrease in volume in comparison to uncoated implants. When compared with uncoated implants, the mechanical properties of the coated implants exhibited a reduction in strength after 3 months. After 6 months, the strength of the coated implants was higher than that of uncoated cylinders.

In vivo study of a biodegradable orthopedic screw (MgYREZr-alloy) in a rabbit model for up to 12 months

Biodegradable magnesium-based implants are currently being developed for use in orthopedic applications. The aim of this study was to investigate the acute, subacute, and chronic local effects on bone tissue as well as the systemic reactions to a magnesium-based (MgYREZr-alloy) screw containing rare earth elements. The upper part of the screw was implanted into the marrow cavity of the left femora of 15 adult rabbits (New Zealand White), and animals were euthanized 1 week, 12 weeks, and 52 weeks postoperatively. Blood samples were analyzed at set times, and radiographic examinations were performed to evaluate gas formation. There were no significant increased changes in blood values compared to normal levels. Histological examination revealed moderate bone formation with direct implant contact without a fibrous capsule. Histopathological evaluation of lung, liver, intestine, kidneys, pancreas, and spleen tissue samples showed no abnormalities. In summary, our data indicate that these magnesium-based screws containing rare earth elements have good biocompatibility and osteoconductivity without acute, subacute, or chronic toxicity.

Predicting failure of thoracic vertebrae with simulated and actual metastatic defects.

Indications for operative treatment in spinal metastatic disease depend on estimates of vertebral loadbearing capacity. There are no noninvasive diagnostic tools for estimating vertebral loadbearing capacity in the presence of a metastatic lesion. Thus, relationships between vertebral failure load and measurements from computed tomography data were investigated to determine if measurements that account for defect size and bone density can predict loadbearing capacity better than can defect size alone. Cylindrical defects were created in thoracic vertebrae of 20 anatomic specimen spinal segments, with 10 other segments serving as controls. Five vertebrae with actual metastatic defects also were tested. Vertebrae were scanned using quantitative computed tomography, and the defect size and the axial rigidity of the midvertebral cross section were calculated using an image analysis program. The spinal segments were tested to failure using a combination of axial compression and anterior flexion. Linear regressions between axial rigidity and absolute failure load showed a high positive correlation, but there was no correlation between defect size and failure load. Axial rigidity may prove useful as a noninvasive assessment of vertebral loadbearing capacity in patients with spinal metastatic disease.

In vivo assessment of the host reactions to the biodegradation of the two novel magnesium alloys ZEK100 and AX30 in an animal model

BackgroundMost studies on biodegradable magnesium implants published recently use magnesium-calcium-alloys or magnesium-aluminum-rare earth-alloys.However, since rare earths are a mixture of elements and their toxicity is unclear, a reduced content of rare earths is favorable. The present study assesses the in vivo biocompatibility of two new magnesium alloys which have a reduced content (ZEK100) or contain no rare earths at all (AX30).Methods24 rabbits were randomized into 4 groups (AX30 or ZEK100, 3 or 6 months, respectively) and cylindrical pins were inserted in their tibiae. To assess the biodegradation μCT scans and histological examinations were performed.ResultsThe μCT scans showed that until month three ZEK100 degrades faster than AX30, but this difference is leveled out after 6 months. Histology revealed that both materials induce adverse host reactions and high numbers of osteoclasts in the recipient bone. The mineral apposition rates of both materials groups were high.ConclusionsBoth alloys display favorable degradation characteristics, but they induce adverse host reactions, namely an osteoclast-driven resorption of bone and a subsequent periosteal formation of new bone. Therefore, the biocompatibility of ZEK100 and AX30 is questionable and further studies, which should focus on the interactions on cellular level, are needed.

PSI kinematic versus non-PSI mechanical alignment in total knee arthroplasty: a prospective, randomized study

PurposeKinematic alignment in TKA is supposed to restore function by aligning the components to the premorbid flexion–extension axis instead of altering the joint line and natural kinematic axes of the knee. The purpose of this study was to compare mechanically aligned TKA to kinematic alignment.MethodsIn this study, 200 patients underwent TKA and were randomly assigned to 2 groups: 100 TKAs were performed using kinematic alignment with custom-made cutting guides in order to complete cruciate-retaining TKA; the other 100 patients underwent TKA that was manually performed using mechanical alignment. The WOMAC and combined Knee Society Score (KSS), as well as radiological alignment, were determined as outcome parameters at the 12-month endpoint.ResultsWOMAC and KSS significantly improved in both groups. There was a significant difference in both scores between groups in favour of kinematic alignment. Although the kinematic alignment group demonstrated significantly better overall results, more outliers with poor outcomes were also seen in this group. A correlation between post-operative alignment deviation from the initial plan and poor outcomes was also noted. The most important finding of this study is that applying kinematic alignment in TKA achieves comparable results to mechanical alignment in TKA. This study also shows that restoring the premorbid flexion–extension axis of the knee joint leads to better overall functional results.ConclusionKinematic alignment is a favourable technique for TKA.Clinical relevanceThe kinematic alignment idea might be a considerable alternative to mechanical alignment in the future.Level of evidenceII.

Core decompression and osteonecrosis intervention rod in osteonecrosis of the femoral head: clinical outcome and finite element analysis

The osteonecrosis of the femoral head implies significant disability partly due to pain. After conventional core decompression using a 10-mm drill, patients normally are requested to be non-weight bearing for several weeks due to the risk of fracture. After core decompression using multiple small drillings, patients were allowed 50% weight bearing. The alternative of simultaneous implantation of a tantalum implant has the supposed advantage of unrestricted load bearing postoperatively. However, these recommendations are mainly based on clinical experience. The aim of this study was to perform a finite element analysis and confirm the results by clinical data after core decompression and after treatment using a tantalum implant. Postoperatively, the risk of fracture is lower after core decompression using multiple small drillings and after the implantation of a tantalum rod according to finite element analysis compared to core decompression of one 10-mm drill hole. According to the results of this study, a risk of fracture exists only during extreme loading. The long-term results reveal a superior performance for core decompression presumably due to the lack of complete bone ingrowth of the tantalum implant. In conclusion, core decompression using small drill holes seems to be superior compared to the tantalum implant and to conventional core decompression.

Comparison of the model-based and marker-based roentgen stereophotogrammetry methods in a typical clinical setting.

Roentgen stereophotogrammetric analysis (RSA) is an established method for the precise measurement of implant migration. Model-based RSA (MBRSA) alleviates the need to attach tantalum markers to the prosthesis, which has prevented wider application of RSA. The goal of this study was to investigate the equivalence of both methods for the clinical measurement of implant migration. Tibial component migration was measured in 24 patients using both methods from the same set of radiographs. The maximum agreement interval, mean (+/-2 standard deviations), of the difference between both methods was modest, at 0.002 mm (0.144 mm) and -0.078 degrees (0.782 degrees ). The results suggest that MBRSA can be used interchangeably with the marker-based method and that the advantages of MBRSA do not come at the cost of a loss in accuracy.