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This phase I clinical trial evaluated the safety and clinical efficacy of adipose‐derived stromal cells (ASCs) in osteoarthritis. Eighteen patients with severe knee osteoarthritis were treated with a single intra‐articular injection of autologous ASCs at low (2 × 106 cells), medium (10 × 106), or high (50 × 106) doses (n = 6 each). After 6 months, no serious adverse events were reported, and patients treated with low‐dose ASCs significantly improved in pain and function. Osteoarthritis (OA) is the most widespread musculoskeletal disorder in adults. It leads to cartilage damage associated with subchondral bone changes and synovial inflammation, causing pain and disability. The present study aimed at evaluating the safety of a dose‐escalation protocol of intra‐articular injected adipose‐derived stromal cells (ASCs) in patients with knee OA, as well as clinical efficacy as secondary endpoint. A bicentric, uncontrolled, open phase I clinical trial was conducted in France and Germany with regulatory agency approval for ASC expansion procedure in both countries. From April 2012 to December 2013, 18 consecutive patients with symptomatic and severe knee OA were treated with a single intra‐articular injection of autologous ASCs. The study design consisted of three consecutive cohorts (six patients each) with dose escalation: low dose (2 × 106 cells), medium dose (10 × 106), and high dose (50 × 106). The primary outcome parameter was safety evaluated by recording adverse events throughout the trial, and secondary parameters were pain and function subscales of the Western Ontario and McMaster Universities Arthritis Index. After 6 months of follow‐up, the procedure was found to be safe, and no serious adverse events were reported. Four patients experienced transient knee joint pain and swelling after local injection. Interestingly, patients treated with low‐dose ASCs experienced significant improvements in pain levels and function compared with baseline. Our data suggest that the intra‐articular injection of ASCs is a safe therapeutic alternative to treat severe knee OA patients. A placebo‐controlled double‐blind phase IIb study is being initiated to assess clinical and structural efficacy. Significance Although this phase I study included a limited number of patients without a placebo arm, it showed that local injection of autologous adipose‐derived stem cells was safe and well tolerated in patients with knee osteoarthritis. This study also provides encouraging preliminary evidence of efficacy. Larger and controlled long‐term studies are now mandatory to confirm whether this new strategy of cell therapy can improve pain and induce structural benefit in osteoarthritis.

Regenerative therapies in the musculoskeletal system are based on the suitable application of cells, biomaterials, and/or factors. For an effective approach, numerous aspects have to be taken into consideration, including age, disease, target tissue, and several environmental factors. Significant research efforts have been undertaken in the last decade to develop specific cell‐based therapies, and in particular adult multipotent mesenchymal stem cells hold great promise for such regenerative strategies. Clinical translation of such therapies, however, remains a work in progress. In the clinical arena, autologous cells have been harvested, processed, and readministered according to protocols distinct for the target application. As outlined in this review, such applications range from simple single‐step approaches, such as direct injection of unprocessed or concentrated blood or bone marrow aspirates, to fabrication of engineered constructs by seeding of natural or synthetic scaffolds with cells, which were released from autologous tissues and propagated under good manufacturing practice conditions (for example, autologous chondrocyte implantation). However, only relatively few of these cell‐based approaches have entered the clinic, and none of these treatments has become a “standard of care” treatment for an orthopaedic disease to date. The multifaceted reasons for the current status from the medical, research, and regulatory perspectives are discussed here. In summary, this review presents the scientific background, current state, and implications of clinical mesenchymal stem cell application in the musculoskeletal system and provides perspectives for future developments.

Background The presented prospective randomized controlled single-centre study compares the clinical outcome up to 12 months after total hip arthroplasty using a minimally invasive single-incision direct anterior (DAA) and a direct transgluteal lateral approach. Methods A total of 123 arthroplasties were evaluated utilizing the Harris Hip Score (HHS), the extra short musculoskeletal functional assessment questionnaire (XSFMA), the Short Form 36 (SF-36) health survey, a Stepwatch™ Activity Monitor (SAM), and a timed 25 m foot walk (T25-FW). Postoperative x-ray images after THA were reviewed to determine inclination and stem positioning. Results At final follow-up, the XSFMA functional index scores were 10.3 (anterior) and 15.08 (lateral) while the bother index summed up to a score of 15.8 (anterior) and 21.66 (lateral) respectively, thus only differing significantly for the functional index ( p  = 0.040 and p  = 0.056). The SF-36 physical component score (PCS) was 47.49 (anterior) and 42.91 (lateral) while the mental component score (MCS) summed up to 55.0 (anterior) and 56.23 (lateral) with a significant difference evident for the PCS ( p  = 0.017; p  = 0.714). Patients undergoing THA through a DAA undertook a mean of 6402 cycles per day while those who had undergone THA through a transgluteal approach undertook a mean of 5340 cycles per day ( p  = 0.012). Furthermore, the obtained outcome for the T25-FW with 18.4 s (anterior) and 19.75 s (lateral) and the maximum walking distance (5932 m and 5125 m) differed significantly ( p  = 0.046 and p  = 0.045). The average HHS showed no significant difference equaling 92.4 points in the anterior group and 91.43 in the lateral group ( p  = 0.477). The radiographic analysis revealed an average cup inclination of 38.6° (anterior) and 40.28° (lateral) without signs of migration. Conclusion In summary, our outcomes show that after 1 year THA through the direct anterior approach results in a higher patient activity compared to THA utilizing a transgluteal lateral approach while no differences regarding hip function are evident. Trial registration DRKS00014808 (German Clinical Trial Register DRKS); date of registration: 31.05.2018.

Purpose The aim of the present study was to compare the daily activity and functionality in a patient cohort 12 months after total hip arthroplasty (THA) using a direct anterior approach with a healthy non-operated control population. Methods Sixty-four patients who underwent THA and 59 healthy individuals (control) were assessed regarding their daily activity and joint functionality utilizing the Harris hip score (HHS), the extra short musculoskeletal functional assessment questionnaire (XSFMA), the Short Form 36 (SF-36) health survey and a Stepwatch™ Activity Monitor (SAM). Post-operative x-ray images after THA were analysed regarding inclination and stem positioning. Results Twelve months after surgery, the average HHS showed no significant difference between both groups equalling 90.7 points in the THA patient group and 90.8 in the healthy volunteer group. The XSFMA functional index scores were 11.0 (THA) and 5.0 (control) while the bother index summed up to a score of 15.3 (THA) and 7.6 (control) respectively thus differing significantly ( p  < 0.001). Daily activity equalled 4227 (THA) and 4687 (control) load cycles per day ( p  = 0.327) while a number of 5658 (THA) and 6417 (control) steps per day ( p  = 0.011) was recorded. The SF-36 physical component scores were 47.3 (THA) and 50.6 (control) points while the psychometric properties added up to a score of 56.1 (THA) and 55.9 (control). The physical component was determined to be significantly different ( p  < 0.001) whereas no statistically significant difference could be shown for the psychometric properties ( p  = 0.511). The radiographic analysis revealed an average cup inclination of 39.9° without signs of migration. Stem positioning was neutral in 53% of all cases while 36% were graded varus and 11% valgus. Conclusion In summary, our short-term results show an activity, functionality and quality of life for patients one year after THA comparable to healthy control individuals.

Fast-track arthroplasty is on the rise in Germany. In comparison to established fast-track countries, such as Denmark and the USA, Germany is only at the beginning of its implementation. The biggest challenges include increasing staff shortages and cost pressure as, well as the slow progress of digitalization. The use of app-based patient management systems offers the opportunity to prepare the patient extensively for the surgical procedure, to rehabilitate them according to a standardized schedule, to avoid unnecessary doctor's visits, to save staff and, thus, reduce healthcare costs. Patient apps will also play an important role in collecting patient data and abnormalities in rehabilitation. By correlating intraoperative data from robotics, predictive statements about the surgical strategy, such as implant positioning or axis alignment may be possible. In this review, the essential contents of an app-based patient management system for fast-track arthroplasty are listed and discussed, and the possibilities for using patient data are presented.

Purpose The presented retrospective study compares clinical outcomes five years after total hip arthroplasty performed through a minimally invasive direct anterior approach and a direct transgluteal lateral approach. Methods A total of 171 arthroplasties in 167 patients were evaluated utilizing the Harris hip score (HHS), the SF-36, a daily activity questionnaire, and the UCLA activity score. Results The average HHS showed no significant difference equalling 91.4 points in the anterior group and 92.4 in the lateral group ( p  = 0.952). The SF-36 physical component scores were 50.7 (anterior) and 50.0 (lateral) while the psychometric properties added up to 48.6 (anterior) and 50.3 (lateral) with no significant differences evident ( p  = 0.782, p  = 0.071). Daily activity was found to result in 4,855 (anterior) and 5,016 (lateral) cycles, respectively ( p  = 0.364). No difference regarding pain sensation was determined ( p  = 0.859). A significant difference was found for the UCLA score, which was calculated to be 5.9 in the anterior and 6.4 in the lateral approach group ( p  = 0.008). Conclusion In summary, our mid-term results show comparable outcomes for both approaches regarding functionality, pain, quality of life and daily activity.

Zusammenfassung Hintergrund Fast-Track-Endoprothetik ist in Deutschland auf dem Vormarsch. Im Vergleich zu den etablierten Fast-Track-Länder, z. B. Dänemark und die USA, stehen wir jedoch erst an den Anfängen der Umsetzung. Zu den größten Herausforderungen gehören der zunehmende Personalmangel und Kostendruck sowie das schleppende Voranschreiten der Digitalisierung. Einsatzmöglichkeiten Die Verwendung von App-basierten Patientenmanagementsystemen bietet die Möglichkeit, den Patienten umfangreich auf den operativen Eingriff vorzubereiten, ihn nach einem standardisierten Zeitplan zu rehabilitieren, unnötige Arztbesuche zu vermeiden, Personal zu sparen und damit die Gesundheitskosten zu senken. Eine wichtige Rolle werden Patienten-Apps auch bei der Erhebung von Patientendaten und Auffälligkeiten in der Rehabilitation spielen. Durch die Korrelation von intraoperativen Daten aus der Robotik werden zukünftig prädiktive Aussagen zur Operationsstrategie, z. B. der Implantatpositionierung oder Achsausrichtung, möglich sein. In der vorliegenden Übersichtsarbeit werden die wichtigsten Inhalte eines App-basierten Patientenmanagementsystems für die Fast-Track-Endoprothetik aufgeführt und diskutiert sowie die Möglichkeiten der Patientendatennutzung dargestellt.

Objective: Proinflammatory cytokines are known to provoke degradative signaling cascades that promote extracellular matrix disintegration in articular cartilage. Because integration of the repair tissue into the surrounding native cartilage to produce a mechanically stable interface has a profound impact on the viability and functionality of the restored joint surface, this study examined the effects of proinflammatory cytokines on the properties of tissue-engineered cartilage in the context of integration. Methods: Using an established in vitro cartilage defect model, we examined the integration of chondrocyte-laden agarose constructs into native articular cartilage and the biochemical and biomechanical alterations of these implants upon treatment with interleukin 1-β (IL1-β) and tumor necrosis factor-α (TNF-α). Additionally, we probed extracellular regulated kinase (ERK) signaling involvement in response to proinflammatory cytokines. Results: The time-dependent accumulation of extracellular matrix and concomitant increase in Young's modulus observed in the absence of cytokines was significantly decreased upon IL1-β and TNF-α treatment. Push-out test showed the highest interface strength in hybrid cultures maintained without cytokines, which was significantly lowered with IL1-β and TNF-α treatment. Histological characteristics of the interface region are consistent with the biochemical findings. Treatment with an inhibitor of ERK pathway antagonized the deleterious effects caused by both cytokines. Conclusion: This study is the first to show the functional catastrophic effects of IL1-β and TNF-α on the biochemical, structural, and integrative properties of tissue-engineered cartilage and their significant counteraction by the blockade of ERK signaling pathway. With the discovery of new potential chemical entities, ERK inhibitor may emerge as a new therapeutic approach for functional integration and mechanical integrity of an engineered cartilage to the host tissue and, therefore, enhance long-term viability and functionality of the restored joint surface.

Seit Einführung der Fast-Track-Chirurgie in der Endoprothetik stellt sich für alle beteiligten Disziplinen die Aufgabe einer engen und kontinuierlichen gemeinsamen Kommunikation im Rahmen der täglichen Routineversorgung. Interdisziplinär vereinbarte Prozesse müssen in regelmäßigen Abständen überprüft, gegebenenfalls angepasst und neu ausgerichtet werden, mit dem Ziel die perioperativen Risiken sowohl medizinisch als auch entlang des Behandlungspfades zu optimieren. Die Verantwortlichkeit des Anästhesisten beschränkt sich hierbei nicht nur auf die Durchführung der Anästhesie, sondern umfasst die Versorgung der Patienten mit dem Blick auf eine optimale Schmerztherapie, den Erhalt der Homöostase und die Sicherstellung einer schnellen Rückkehr der patienteneigenen Selbstbestimmung.

Purpose Bone defects resulting from tumour resection or curettage are most commonly reconstructed with autologous bone graft which is associated with limited availability and donor site morbidity. Recent research has focussed on synthetic biomaterials as bone graft substitutes. The aim of this study was to assess the safety and efficiency of a bone substitute as an alternative for autologous bone in the treatment of benign bone tumours and tumour-like lesions. Methods In the present study, a biphasic ceramic (60% HA and 40% β-TCP) combined with a fibrin sealant was used to reconstruct defects in 51 patients after curettage of benign bone tumours or tumour-like lesions. Patient age ranged from eight to 68 years (mean 29.7), defect size from 2 cm 3 to 35 cm 3 (mean 12.1), and time of follow-up from one to 56 months (mean 22.7). Results Radiologic analysis showed complete bony defect consolidation in 50 of 51 patients after up to 56 months. No postoperative fractures were observed. Revision surgery had to be performed in one case. Histological analysis showed new bone formation and good biocompatibility and osseointegration of the implanted material. Conclusion In summary, the biphasic ceramic in combination with fibrin sealant was proven an effective alternative to autologous bone grafts eliminating the risk of donor site morbidity for the patient.