MoRe – Mobile Research: App-basierte Studien nach dem Baukastenprinzip

Die Erfassung der Effektivität von Behandlungsmethoden sowie von Therapieergebnissen steht in einer ergebnisorientierten medizinischen Versorgung immer mehr im Vordergrund klinischen und wissenschaftlichen Interesses. Daher erwarten Experten von mobilen Gesundheitslösungen (mHealth) unter anderem Verbesserungen in der Gesundheitsvorsorge und Krankheitsfrüherkennung, Kosteneinsparungen und/oder Qualitätsverbesserungen in der Leistungserbringung. Ziel des Projektes ist die Etablierung einer universellen Applikation, die es dem Anwender ermöglicht - entsprechend aktueller Standards in Bezug auf Patientensicherheit und Datenschutz und guter klinischer Praxis - ohne individuelle Programmierkenntnisse ein eigenes Forschungsprojekt zur systematischen und hochwertigen Datenerfassung von Patienten mit unterschiedlichsten Pathologien zusammenzustellen. Dabei werden, gemäß der immer wichtiger werdenden Versorgungsforschung, Patient-reported Outcome Parameter als wertvolles und zunehmend etabliertes Instrument zur Untersuchung von Therapieergebnissen eingesetzt. Lebensqualität als wichtiger messbarer Parameter bei nicht-vitalen Indikationen sei hier nur als Beispiel genannt. Zusammengestellte Studien werden über eine Smartphone-App für den Patienten zugänglich. Die hierdurch erfassten Daten kann der Wissenschaftler über eine webbasierte Oberfläche analysieren und zur weiteren Auswertung herunterladen. Öffentliche Studien können weltweit innerhalb der App gesucht werden. Geschlossene Studien sind privat

Composite-object views in relational DBMS: an implementation perspective

We present a novel approach for supporting Composite Objects (CO) as an abstraction over the relational data. This approach brings the advanced CO model to existing relational databases and applications, without requiring an expensive migration to other DBMSs which support CO. The concept of views in relational DBMSs (RDBMS) gives the basis for providing the CO abstraction. This model is strictly an extension to the relational model, and it is fully upward compatible with it. We present an overview of the data model. We put emphasis in this paper on showing how we have made the extensions to the architecture and implementation of an RDBMS (Starburst) to support this model. We show that such a major extension to the data model is in fact quite attractive both in terms of implementation cost and query performance. We introduce a CO cache for navigation through components of a CO. With this technique, the performance of navigation through COs, which has been of a concern in RDBMSs in the past, is in fact quite satisfactory. We present our practical experience in using this facility. We show that our work on CO enables existing RDBMSs to incorporate efficient CO facilities at a low cost and at a high degree of application reusability and database sharability

Quadriceps Strength in Patients With Isolated Cartilage Defects of the Knee : Results of Isokinetic Strength Measurements and Their Correlation With Clinical and Functional Results.

Background: Recent studies have found a significant deficit of maximum quadriceps strength after autologous chondrocyte implantation (ACI) of the knee. However, it is unclear whether muscular strength deficits in patients with cartilage damage exist prior to operative treatment. Purpose: To isokinetically test maximum quadriceps muscle strength and quantify the impact of possible strength deficits on functional and clinical test results. Study Design: Cross-sectional study; Level of evidence, 3. Methods: To identify clinically relevant muscular strength deficits, 24 patients (5 females, 19 males; mean age, 34.5 years; body mass index, 25.9 kg/m2) with isolated cartilage defects (mean onset, 5.05 years; SD, 7.8 years) in the knee joint underwent isokinetic strength measurements. Maximal quadriceps strength was recorded in 3 different testing modes: pure concentric contraction (flexors and extensors alternating work; con1), concentric-eccentric (only the extensors work concentrically and eccentrically; con2), and eccentric contraction in the alternating mode (ecc). Results were compared for functional performance (single-leg hop test), pain scales (visual analog scale [VAS], numeric rating scale [NRS]), self-reported questionnaires (International Knee Documentation Committee [IKDC], Knee Injury and Osteoarthritis Outcome Scale [KOOS]), and defect size (cm2). Results: Compared with the uninjured leg, significantly lower quadriceps strength was detected in the injured leg in all isokinetic working modes (con1 difference, 27.76 N·m [SD 17.47; P = .003]; con2 difference, 21.45 N·m [SD, 18.45; P =.025]; ecc difference, 29.48 N·m [SD, 21.51; P = .001]), with the largest deficits found for eccentric muscle performance. Moderate negative correlations were observed for the subjective pain scales NRS and VAS. The results of the IKDC and KOOS questionnaires showed low, nonsignificant correlations with findings in the isokinetic measurement. Moreover, defect sizes (mean, 3.13 cm2) were of no importance regarding the prediction of the strength deficit. The quadriceps strength deficit between the injured and the uninjured leg was best predicted by the results of the single-leg hop test. Conclusion: Patients with isolated cartilage defects of the knee joint have significant deficits in quadriceps muscle strength of the injured leg compared with the uninjured leg. The single-leg hop test may be used to predict quadriceps strength deficits. Future research should address whether preoperative strength training in patients with cartilage defects of the knee could be effective and should be taken into consideration in addition to surgical treatment. Keywords muscle strength, isokinetic, cartilage defect, cartilage repair, knee joint, rehabilitatio

SQL/XNF - processing composite objects as abstractions over relational data

An extension to SQL, called the SQL extended normal form (XNF), is discussed. It enhances relational technology by a composite object facility, which comprises not only extraction of composite objects from existing databases but also efficient navigation and manipulation facilities provided by an appropriate application programming interface. The language itself allows sharing of the database among normal form SQL applications and composite object applications. It provides proper subsetting of the database and subsequent structuring, exploiting subobject sharing and recursion, all based on its powerful composite object constructor concept, which is closed under the language operations. XNF is integrated into the relational framework, thus benefiting from the available technology such as relational engine and query optimization

A new technique for seeding chondrocytes onto solvent-preserved human meniscus using the chemokinetic effect of recombinant human bone morphogenetic protein-2

Many investigators are currently studying the use of decellularized tissue allografts from human cadavers as scaffolds onto which patients’ cells could be seeded, or as carriers for genetically engineered cells to aid cell transplantation. However, it is difficult to seed cells onto very dense regular connective tissue which has few interstitial spaces. Here, we discuss the development of a chemotactic cell seeding technique using solvent-preserved human meniscus. A chemokinetic response to recombinant human bone morphogenetic protein-2 (rhBMP-2) was observed in a monolayer culture of primary chondrocytes derived from femoral epiphyseal cartilage of 2-day-old rats. The rhBMP-2 significantly increased their migration upto 10 ng/ml in a dose-dependent manner. When tested with solvent-preserved human meniscus as a scaffold, which has few interstitial spaces, rhBMP-2 was able to induce chondrocytes to migrate into the meniscus. After a 3-week incubation, newly-formed cartilaginous extracellular matrix was synthesized by migrated chondrocytes throughout the meniscus, down to a depth of 3 mm. These findings demonstrate that rhBMP-2 may be a natural chemokinetic factor in vivo, which induces migration of proliferative chondrocytes into the narrow interfibrous spaces. Our results suggest a potential application of rhBMP-2 for the designed distribution of chondrocytes into a scaffold to be used for tissue engineering

Association between expression of the Bone morphogenetic proteins 2 and 7 in the repair of circumscribed cartilage lesions with clinical outcome

<p>Abstract</p> <p>Background</p> <p>Although there is much known about the role of BMPs in cartilage metabolism reliable data about the <it>in vivo </it>regulation in natural and surgically induced cartilage repair are still missing.</p> <p>Methods</p> <p>Lavage fluids of knee joints of 47 patients were collected during surgical therapy. 5 patients had no cartilage lesion and served as a control group, the other 42 patients with circumscribed cartilage defects were treated by microfracturing (19) or by an Autologous Chondrocyte Implantation (23). The concentrations of BMP-2 and BMP-7 were determined by ELISA. The clinical status was evaluated using the IKDC Score prior to and 1 year following the operation.</p> <p>Results</p> <p>High level expression in the control group was found for BMP-2, concentrations of BMP-7 remained below detection levels. No statistical differences could be detected in concentrations of BMP-2 or BMP-7 in the lavage fluids of knees with cartilage lesions compared to the control group. Levels of BMP-7 did not change after surgical cartilage repair, whereas concentrations of BMP-2 statistically significant increased after the intervention (p < 0.001). The clinical outcome following cartilage regenerating surgery increased after 1 year by 29% (p < 0.001). The difference of the IKDC score after 1 year and prior to the operation was used to quantify the degree of improvement following surgery. This difference statistically significant correlated with initial BMP-2 (R = 0.554, p < 0.001) but not BMP-7 (R = 0.031, n.s.) levels in the knee joints.</p> <p>Conclusions</p> <p>BMP-2 seems to play an important role in surgically induced cartilage repair; synovial expression correlates with the clinical outcome.</p

A Multicentric, Open-Label, Randomized, Comparative Clinical Trial of Two Different Doses of Expanded hBM-MSCs Plus Biomaterial versus Iliac Crest Autograft, for Bone Healing in Nonunions after Long Bone Fractures: Study Protocol

ORTHOUNION is a multicentre, open, comparative, three-arm, randomized clinical trial (EudraCT number 2015-000431-32) to compare the efficacy, at one and two years, of autologous human bone marrow-derived expanded mesenchymal stromal cell (hBM-MSC) treatments versus iliac crest autograft (ICA) to enhance bone healing in patients with diaphyseal and/or metaphysodiaphyseal fracture (femur, tibia, and humerus) status of atrophic or oligotrophic nonunion (more than 9 months after the acute fracture, including recalcitrant cases after failed treatments). The primary objective is to determine if the treatment with hBM-MSCs combined with biomaterial is superior to ICA in obtaining bone healing. If confirmed, a secondary objective is set to determine if the dose of 100 × 106 hBM-MSCs is noninferior to that of 200 × 106 hBM-MSCs. The participants (n = 108) will be randomly assigned to either the experimental low dose (n = 36), the experimental high dose (n = 36), or the comparator arm (n = 36) using a central randomization service. The trial will be conducted in 20 clinical centres in Spain, France, Germany, and Italy under the same clinical protocol. The confirmation of superiority for the proposed ATMP in nonunions may foster the future of bone regenerative medicine in this indication. On the contrary, absence of superiority may underline its limitations in clinical use