High Failure Research Articles

Evidence-Based Critical Assessment of the Success Rate of Dental Implants in Smokers: An Umbrella Systematic Review.

The aim of this umbrella systematic review is to evaluate the success rate and osseointegration of dental implants in patients with a smoking habit. Electronic database searches of PubMed/Medline, Google Scholar, ScienceDirect, Cochrane Library, and EBSCOhost were done from 2006 until August 2024, using medical subject headings (MeSH) terms. Systematic reviews and meta-analyses (SRMAs) investigating the association between smoking and the rate of success of dental implants based on dental implant failure, marginal bone loss, survival, and peri-implant parameters were deemed eligible. The Assessment of Multiple Systematic Reviews Tool 2 (AMSTAR 2) was used to assess the quality of the included SRMAs. Seventeen systematic reviews have been included. In the reviews, 10 studies included meta-analyses (MAs) that evaluated implant failure rate and marginal bone loss. According to the AMSTAR 2 checklist, one review was scored "high," seven reviews were scored "moderate," seven reviews were scored "low," and two reviews were scored "critically low" quality. The strength of evidence suggests a low level of success and high rate of failure of osseointegration of dental implants in smokers. However, the influence of smoking on the rate of dental implant failure seems to be associated with various factors such as peri-implant inflammatory markers, post-operative infections, etc. Inherently, the conclusion of this review is based on a limited number of systematic reviews.

Mesenchymal Stem Cell-Conditioned Media-Loaded Microparticles Enhance Acute Patency in Silk-Based Vascular Grafts.

Coronary artery disease leads to over 360,000 deaths annually in the United States, and off-the-shelf bypass graft options are currently limited and/or have high failure rates. Tissue-engineered vascular grafts (TEVGs) present an attractive option, though the promising mesenchymal stem cell (MSC)-based implants face uncertain regulatory pathways. In this study, "artificial MSCs" (ArtMSCs) were fabricated by encapsulating MSC-conditioned media (CM) in poly(lactic-co-glycolic acid) microparticles. ArtMSCs and control microparticles (Blank-MPs) were incubated over 7 days to assess the release of total protein and the vascular endothelial growth factor (VEGF-A); releasates were also assessed for cytotoxicity and promotion of smooth muscle cell (SMC) proliferation. Each MP type was loaded in previously published "lyogel" silk scaffolds and implanted as interposition grafts in Lewis rats for 1 or 8 weeks. Explanted grafts were assessed for patency and cell content. ArtMSCs had a burst release of protein and VEGF-A. CM increased proliferation in SMCs, but not after encapsulation. TEVG explants after 1 week had significantly higher patency rates with ArtMSCs compared to Blank-MPs, but similar to unseeded lyogel grafts. ArtMSC explants had lower numbers of infiltrating macrophages compared to Blank-MP explants, suggesting a modulation of inflammatory response by the ArtMSCs. TEVG explants after 8 weeks showed no significant difference in patency among the three groups. The ArtMSC explants showed higher numbers of SMCs and endothelial cells within the neotissue layer of the graft compared to Blank-MP explants. In sum, while the ArtMSCs had positive effects acutely, efficacy was lost in the longer term; therefore, further optimization is needed.

Venture Studios: Beyond Entrepreneurial Support Organisations? A Case Study Analysis and Framework

We examine and discuss the rise of the Venture Studio phenomenon (also called Startup Studio), which is receiving increasing attention across the globe. Venture Studios promises to mitigate the high failure rates faced by new ventures by engaging earlier in the new venture creation process, contributing from ideation at pre-venture stage. Venture Studios generate business ideas, and then partner with external entrepreneurs to build and validate the new businesses. Despite their increasing prominence, little is known regarding the design choices, activities, and outcomes of Venture Studios, as well as how they differ from other established organisations such as incubators and accelerators. This research aims to fill this gap, by conducting an exploratory case study involving interviews with 14 Venture Studios in Italy. We introduce an I–P–O framework that provides a comprehensive set of design choices and activities that characterise Venture Studios. Findings reveal significant heterogeneity in design choices, indicating no one-size-fits-all approach. Despite this, consistency exists in their processes and entrepreneurial orientation. Second, we question the nature of Venture Studios as Entrepreneurial Support Organisations (ESOs), proposing that they represent a new category with a more active, co-founder-like role. This study also seeks to equip Venture Studio managers with a framework to understand and strategically navigate the diverse approaches within their field. Also, we offer insights to entrepreneurs, investors, and other stakeholders, enabling them to understand the functioning of this novel form of organisation.

Mapping Staphylococcus aureus at Early and Late Stages of Infection in a Clinically Representative Hip Prosthetic Joint Infection Rat Model.

Prosthetic joint infection (PJI) continues to be a devastating complication following total joint replacement surgeries where Staphylococcus aureus is the main offending organism. To improve our understanding of the disease pathogenesis, a histological analysis of infected peri-implant tissue in a hip PJI rat model was utilized to assess S. aureus spread and tissue reaction at early and late stages of infection. Sprague-Dawley rats were used and received a left cemented hip hemiarthroplasty using a 3D-printed titanium femoral stem. The rats received an intra-articular injection of S. aureus Xen36. These infected rats were sacrificed either at 3 days post-infection (early-stage infection) or at 13-days post-infection (late-stage infection). The femoral and acetabular tissues of all animals were harvested at euthanasia. Histological analysis for the harvested tissue was performed using immunohistochemistry, hematoxylin and eosin, as well as Masson's trichrome stains. Histological examination revealed significant quantitative and qualitative differences in peri-implant tissue response to infection at early and late stages. This hip PJI rat model identified clear histologic differences between early and late stages of S. aureus infection and how quickly bacterial infiltration could occur. These findings can provide insight into why certain surgical strategies like debridement and antibiotics may be associated with high failure rates.

DrugMAP 2.0: molecular atlas and pharma-information of all drugs.

The escalating costs and high failure rates have decelerated the pace of drug development, which amplifies the research interests in developing combinatorial/repurposed drugs and understanding off-target adverse drug reaction (ADR). In other words, it is demanded to delineate the molecular atlas and pharma-information for the combinatorial/repurposed drugs and off-target interactions. However, such invaluable data were inadequately covered by existing databases. In this study, a major update was thus conducted to the DrugMAP, which accumulated (a) 20831 combinatorial drugs and their interacting atlas involving 1583 pharmacologically important molecules; (b) 842 repurposed drugs and their interacting atlas with 795 molecules; (c) 3260 off-targets relevant to the ADRs of 2731 drugs and (d) various types of pharmaceutical information, including diverse ADMET properties, versatile diseases, and various ADRs/off-targets. With the growing demands for discovering combinatorial/repurposed therapies and the rapidly emerging interest in AI-based drug discovery, DrugMAP was highly expected to act as an indispensable supplement to existing databases facilitating drug discovery, which was accessible at: https://idrblab.org/drugmap/.

Clinical trials in-a-dish for cardiovascular medicine.

Cardiovascular diseases persist as a global health challenge that requires methodological innovation for effective drug development. Conventional pipelines relying on animal models suffer from high failure rates due to significant interspecies variation between humans and animal models. In response, the recently enacted Food and Drug Administration Modernization Act 2.0 encourages alternative approaches including induced pluripotent stem cells (iPSCs). Human iPSCs provide a patient-specific, precise, and screenable platform for drug testing, paving the way for cardiovascular precision medicine. This review discusses milestones in iPSC differentiation and their applications from disease modelling to drug discovery in cardiovascular medicine. It then explores challenges and emerging opportunities for the implementation of 'clinical trials in-a-dish'. Concluding, this review proposes a framework for future clinical trial design with strategic incorporations of iPSC technology, microphysiological systems, clinical pan-omics, and artificial intelligence to improve success rates and advance cardiovascular healthcare.

Diamond-like carbon (DLC) surface treatment decreases biofilm burden by S. aureus on titanium alloy in vitro- a pilot study.

Periprosthetic joint infection is a complication of total joint arthroplasty with treatment costs over $1.6billion dollars per year in the US with high failure rates. Therefore, generation of coatings that can prevent infection is paramount. Diamond-like carbon (DLC) is an ideal coating for implants as they are wear-resistant, corrosion-resistant, inert, and have a low friction coefficient. The purpose of this study was to test the efficacy of DLC surface treatment in prevention of biofilm on titanium discs infected with Staphylococcus aureus in vitro. Titanium alloy discs (n = 4 non-coated and n = 4 DLC-coated) were infected with 5 × 105 colony-forming units (CFU) of S. aureus for 2 weeks then analysed via crystal violet and scanning electron microscopy (SEM). Crystal violet analysis yielded differences in the appearance of biofilm on implant surface where DLC-coated had a clumpier appearance but no difference in biofilm quantification. Interestingly, this clumpy appearance did lead to differences in SEM biofilm coverage where significantly less biofilm coverage was found on DLC-coated discs (81.78% vs. 54.17%, p < 0.003). DLC-coated titanium alloy implants may have preventative properties in S. aureus infection. Observing differences in biofilm coverage does warrant additional testing including CFU titration and biofilm kinetics with eventual use in an animal model of periprosthetic joint infection.

An Economic Perspective on the Implementation of Artificial Intelligence in the Restaurant Sector

Technology is evolving and being implemented across nearly every sector of society, including health, nutrition, and sustainability. Specifically, artificial intelligence (AI) has become an essential tool in gastronomy, not only facilitating chefs’ work but also fostering business innovation through cost reduction. However, for a gastronomic business to be profitable, it is crucial to understand its strategic elements. In this study, three groups associated with gastronomy—chefs, entrepreneurs, and gastronomic experts—were surveyed to gather their opinions on the application of artificial intelligence in the restaurant sector in Spain. Additionally, the Business Model Canvas and Lean Model Canvas were developed, specifically adapted for the restaurant sector. These models, as novel approaches, allowed for the identification of key success factors based on the respondents’ experiences, considering that the Business Model Canvas focuses on the market and the company, while the Lean Model Canvas prioritizes the market and the product. This distinction is essential for mitigating the high failure rate in the restaurant industry in Spain. The results from the Canvas models and SWOT analysis have allowed us to understand the participants’ views. They largely see the use of AI in gastronomy as beneficial due to innovation in recipes and cost savings. However, concerns were raised about the potential loss of human touch in dish preparation and increased unemployment due to the automation of some cooking processes. These findings could be highly relevant for future restaurant entrepreneurs.

Prediction of Wind Turbine Gearbox Oil Temperature Based on Stochastic Differential Equation Modeling

Aiming at the problem of high failure rate and inconvenient maintenance of wind turbine gearboxes, this paper establishes a stochastic differential equation model that can be used to fit the change of gearbox oil temperature and adopts an iterative computational method and Markov-based modified optimization to fit the prediction sequence in order to realize the accurate prediction of gearbox oil temperature. The model divides the oil temperature change of the gearbox into two parts, internal aging and external random perturbation, adopts the approximation theorem to establish the internal aging model, and uses Brownian motion to simulate the external random perturbation. The model parameters were calculated by the Newton–Raphson iterative method based on the gearbox oil temperature monitoring data. Iterative calculations and Markov-based corrections were performed on the model prediction data. The gearbox oil temperature variations were simulated in MATLAB, and the fitting and testing errors were calculated before and after the iterations. By comparing the fitting and testing errors with the ordinary differential equations and the stochastic differential equations before iteration, the iterated model can better reflect the gear oil temperature trend and predict the oil temperature at a specific time. The accuracy of the iterated model in terms of fitting and prediction is important for the development of preventive maintenance.

Long-term outcomes of acetabular impaction grafting with cemented cups and trabecular metal for revision hip arthroplasty: a follow-up study.

Revision hip arthroplasty in the presence of complex acetabular deficiencies is challenging. Cement, allograft, reconstruction rings and porous trabecular metal now provide versatile options for acetabular fixation and restoration of acetabular offset. We compare acetabular impaction bone grafting (AIBG) and trabecular metal (TM) cups at long-term follow-up. 53 patients who underwent revision hip arthroplasty were retrospectively reviewed from local joint registry data. 36 patients were revised using AIBG and 17 with TM. Median clinical follow-up was 9.57 (2.46-18.72) years and 9.65 (7.22-12.46) years, respectively. 82% of the TM group and 63% of the AIBG group were ⩾ Paprosky 2C. Re-revision was considered failure. Radiographs demonstrating 5 mm of femoral head migration and 5° of acetabular component inclination change were considered loose. Patients receiving AIBG were younger (68 vs. 74 years) with a longer interval from initial arthroplasty to revision (17 vs. 13 years). Revisions in both groups were indicated most commonly for failed cementing (AIBG 88.9% vs. TM 70.5%). No TM reconstructions underwent re-revision, with only 1 failing at 6.3 years, compared with 9 AIBG re-revisions. When revising for sepsis, 33% of AIBG revisions failed. AIBG demonstrated high failure rates at long-term follow-up when compared to TM constructs. We recommend the use of AIBG in small cavitary defects only. We strongly advise against its use in the setting of significant bony defects and for prosthetic joint infection.

Indications and Long-Term Outcomes of Intercalary Reconstruction Techniques for Diaphyseal Bone Tumors

Objective: Intercalary reconstruction after resection of diaphyseal bone tumors allows for adjacent-joint preservation; however, despite implant advancements they continue to experience high failure rates. Free fibular autograft (FFA), allograft interposition, and metallic endoprostheses are used, but there is no consensus on optimal construct. Methods: We conducted an IRB-approved retrospective review of patients who underwent intercalary reconstruction for oncologic indications at a single institution (1999 to 2022). Inclusion criteria included intercalary reconstruction with FFA, allograft, or endoprosthesis for oncologic indications and with minimum follow-up of 3 months. Primary outcome was implant survival. Secondary outcomes included complication type, rate, and timing, resection length, distance from articular surface, and failure modes. Results: Thirty-five patients met inclusion criteria, 23 men and 12 women. Reconstructive options included: FFA (N=8), endoprosthesis (N=16), and allograft (N=11). Average follow-up was 3.9 years. Average patient age was 41.8 years; FFA patients were younger than endoprosthesis patients (P=0.0002). FFAs were closer to the articular surface than endoprostheses (P=0.0003). Overall implant survival was 36.6% at 21 years; median survival was 2.04 years. Overall complication rate was 65.7%, with no difference between groups. Ten patients (28.5%) ultimately ended with a joint-sacrificing operation. Conclusions: This study supports the existing literature’s reported high rate of complication and implant failure of intercalary reconstructions. Salvage options are available, including those for secondary joint-sparing operations; however, they often result in a joint-sacrificing endoprosthesis limiting function and longevity. With patients having improved life expectancy for both metastatic and primary bone tumors, implant optimization is critical.

Research on a Novel Heat Treatment Process for Boron Steel Used for Soil-Engaging Components of Tillage Machinery

To address the issue of high fracture and wear failure rates caused by the lack of toughness and abrasion resistance in the steel used for soil-engaging components of tillage machinery, a novel composite heat treatment process, “normalizing and intercritical quenching and tempering (NIQT)”, is proposed. By regulating the austenitizing heating temperature in the intercritical area (ferrite/austenite two-phase area), the type, content, and distribution of phases in the 27MnCrB5 test sample could be precisely controlled, which further influenced the mechanical properties of the material. The results demonstrated that a multiphase composite microstructure, predominantly consisting of martensite and ferrite, could be obtained in the 27MnCrB5 steel treated by the NIQT process. The results of an EBSD test indicated that the predominant type of grain boundary following the NIQT heat treatment was a high-angle grain boundary (approximately 59.5%), which was favorable for hindering crack propagation and improving the impact toughness of the material. The results of the mechanical tests revealed that, when the quenching temperature was set to 790 °C, the 27MnCrB5 steel attained excellent comprehensive mechanical properties, with a tensile strength of 1654 MPa, elongation of 10.4%, impact energy of 77 J, and hardness of 530 HV30. Compared with conventional heat treatment processes for soil-engaging components, this novel process has the potential to enhance the performance of soil-engaging components and prolong their service life.

Peran Digital Marketing Berbasis Media Sosial Untuk Meningkatkan Volume Penjualan dan Mencapai Keberhasilan Usaha

This study aims to analyse the effect of social media-based digital marketing on increasing sales volume and business success of MSMEs in Banjarbaru City. The problem is focused on the high failure rate experienced by MSMEs, so efforts are needed to increase the sales volume of MSMEs through social media-based digital marketing and achieve business success. The research method used is descriptive research with a quantitative approach. The sample was taken using purposive sampling technique as many as 168 MSME players in Banjarbaru City. Data collection techniques through observation, interviews and questionnaires to MSME actors and by taking references from journals, books and other relevant sources. Data analysis in this study was carried out using descriptive statistical analysis, path analysis, classical assumption analysis, simple regression analysis and partial test (t-test). The results showed that there is a positive influence between social media-based digital marketing on sales volume and business success of MSMEs in Banjarbaru City.

Instability and the Anatomic Total Shoulder Arthroplasty.

Instability of the anatomic total shoulder arthroplasty is a challenging problem. With an incidence of 1% to 5% reported in the literature, it is critical for shoulder surgeons to understand and be capable of addressing this complication. Etiology is multifactorial and related to soft-tissue imbalance, osseous pathology, implant malposition, or more commonly, a combination of these various causes. Historically, high rates of failure have been reported after revision procedures, prompting a movement toward the more inherently stable reverse shoulder arthroplasty as a reliable form of management. However, this may not be the ideal solution for all patients, particularly the young and active population. Consequently, the purpose of this article was to provide a review of the literature on the management of postoperative instability and intraoperative strategies to prevent this complication during the index procedure.

Microbiology, Treatment, and Postoperative Outcomes of Gram-Negative Prosthetic Joint Infections-A Systematic Review of the Literature.

Gram-negative prosthetic joint infections (PJIs) represent 10% to 25% of all PJIs and are associated with worse outcomes than gram-positive infections. We sought to assess the microbiology, surgical treatment, and outcomes of patients with gram-negative PJIs. A systematic review using the PubMed and Embase databases was conducted. Our study was conducted following the PRISMA guidelines. Included studies were assessed for quality using the STROBE checklist. The primary outcome of analysis was treatment failure. A total of 593 patients with gram-negative PJIs were included. Two-year survival free of treatment failure for hip and knee PJIs was 66% and 68% for acute infections, 39% and 78% for acute hematogenous infections, and 75% and 63% for chronic infections, respectively. Two-year survival free of treatment failure for acute infections treated with débridement, antibiotics, and implant retention was 65% and 67% for hip and knee PJIs, respectively. Exchange of the polyethylene during débridement, antibiotics, and implant retention was associated with higher treatment success (P = 0.045). Chronic PJIs treated with two-stage revision had a two-year treatment success rate of 87% and 65% for the hip and knee, respectively. Risk factors of treatment failure were chronic obstructive pulmonary disease and C-reactive protein ≥30 mg/L in acute PJIs and female sex, knee infection, and previously revised implant in chronic PJIs. Acute PJIs caused by Pseudomonas spp. were associated with lower treatment failure rates. Gram-negative PJIs are associated with a high treatment failure rate. Patient comorbidities, preoperative biochemical tests, microorganism etiology, and PJI characteristics affected the treatment success rate.

Haploidentical Stem Cell Transplantation With TCR αβ+/CD19+ Depletion in Children With Nonmalignant Hematologic Disorders: Outcomes From a Referral Center in Peru

BackgroundHaploidentical hematopoietic stem cell transplantation (haplo-HSCT) with TCR αβ+/CD19+ cell depletion is a promising therapeutic alternative for children with nonmalignant hematologic disorders, especially in low-income countries where finding a compatible donor is challenging. The use of this transplantation approach for nonmalignant hematologic disorders has not been previously described in the Peruvian pediatric population. MethodsWe present the outcomes of children under 19 with nonmalignant hematologic disorders who underwent haplo-HSCT with TCR αβ+/CD19+ cell depletion between 2018-2022 at a referral center in Lima, Peru. Survival probabilities and cumulative incidence functions were calculated using the Kaplan-Meier method. ResultsA total of 17 children aged between 1 to 18.6 years (median = 9.7 years) were included. The follow-up period ranged from 10 days to 66.20 months, with a median of 4.34 months. The probability of overall survival, event-free survival, and failure-free survival was 33.70%, 31.40%, and 68.8%, respectively. The incidence rate of graft failure was 49.80%, while the mortality rate not associated with graft failure was 18.8%. The incidence rate of acute graft-versus-host disease (GvHD) was 25.60%, and the incidence rate of viral infections was 59.40%. ConclusionsThe high incidence rates of graft failure and viral infections suggest that these factors may negatively impact the survival of children with nonmalignant hematologic disorders who undergo haplo-HSCT with TCR αβ+/CD19+ cell depletion. Therefore, optimizing the current conditioning regimens and ensuring timely access to first, second, and third-line antivirals is crucial to improve the survival of these patients.

Revolutionizing Drug Discovery: The Impact of Distinct Designs and Biosensor Integration in Microfluidics-Based Organ-on-a-Chip Technology.

Traditional drug development is a long and expensive process with high rates of failure. This has prompted the pharmaceutical industry to seek more efficient drug development frameworks, driving the emergence of organ-on-a-chip (OOC) based on microfluidic technologies. Unlike traditional animal experiments, OOC systems provide a more accurate simulation of human organ microenvironments and physiological responses, therefore offering a cost-effective and efficient platform for biomedical research, particularly in the development of new medicines. Additionally, OOC systems enable quick and real-time analysis, high-throughput experimentation, and automation. These advantages have shown significant promise in enhancing the drug development process. The success of an OOC system hinges on the integration of specific designs, manufacturing techniques, and biosensors to meet the need for integrated multiparameter datasets. This review focuses on the manufacturing, design, sensing systems, and applications of OOC systems, highlighting their design and sensing capabilities, as well as the technical challenges they currently face.

Urethroplasty- a single centre single surgeon experience.

Male urethral stricture affects 100 in 100,000 men. These are investigated using uroflowmetry, retrograde urethrography and cystourethroscopy. Management is usually endoscopic with urethral dilation or direct visual internal urethrotomy, although they have high failure rates. It is now recommended that urethroplasty is performed earlier. In this study we have reviewed a single surgeons experience with urethroplasty and patient outcomes. We retrospectively reviewed a prospectively maintained database of all urethroplasty operations performed in our hospital over a 5 -year period. Forty-five patients were identified, with a mean age of 46. The most common presenting symptom was poor flow (100%). Uroflowmetry was performed in 31 of 45 patients(69%). More patients had a urethrogram (58%) than flexible cystoscopy (38%). Most strictures were idiopathic (67%). Mean stricture length was 2.6cm. 71% did not require any further intervention. Five patients required repeat surgery. Four required DVIU and one required a repeat urethroplasty. The most popular techniques for urethroplasty in the UK are augmentation urethroplasty using a buccal mucosal graft and anastomotic urethroplasty, both of which we describe. There are variations in what is deemed as successful surgery. The most widely used definition is 'the lack of need for any further operative intervention'. We have recently adopted Patient Reported Outcome Measures using a validated questionnaire to measure the patients perception of a successful outcome. Complex strictures have a higher incidence of complications. 42% of our cohort were complex and we describe results comparable to the published literature.

Replantation After Dental Avulsion: A Scoping Review and Proposal of a Flow Chart.

Dental avulsion, the complete displacement of a tooth from its socket, is a severe dental trauma with a prevalence of 0.5% to 16% of all dental injuries. Replantation of avulsed teeth is common, yet recent studies show high failure rates and unpredictable long-term outcomes. This review examines clinical variables influencing intentional dental replantation decisions and proposes a treatment flow chart. A comprehensive literature search was conducted in PubMed-Medline, Scopus, WoS, and Cochrane databases using the keywords "tooth avulsion," "tooth replantation," and "tooth ankylosis." Inclusion criteria encompassed studies from January 2018 to February 2024. From 752 identified articles, 9 systematic reviews including 3 meta-analyses were selected for this scoping review. Immediate replantation is the gold standard for avulsed teeth, yet delayed replantation is more common in practice, impacting survival rates. Adherence to guidelines from the International Association on Dental Traumatology improves outcomes, especially in paediatric patients. Factors such as multiple caries, severe periodontal disease, advanced age, psychological conditions, immunodeficiency, and lack of cooperation are contraindications for replantation. Despite the high failure rate, replantation remains recommended in literature due to its potential advantages over prosthetic implants. This review highlights the complexities in decision-making for dental replantation, emphasising the need for a comprehensive approach considering individual clinical cases. A proposed treatment flow chart aims to support clinicians in predicting prognosis and making informed decisions. The review also underscores the link between dental trauma, poor oral health, and potential neglect in children, highlighting the importance of preventive measures and parental awareness.

High failure rate but promising clinical performance after implantation of a flexible medial meniscus prosthesis at 1-year follow-up.

After unsatisfactory results in a first-in-human clinical investigation with an anatomically shaped medial meniscus prosthesis, the prosthesis and its fixation technique were altered. This interim analysis of a prospective single-arm clinical investigation aims to evaluate safety and clinical performance in a first-in-human study with the redesigned meniscus prosthesis system. Ten patients suffering from medial postmeniscectomy pain syndrome were treated with the meniscus prosthesis. Patient-reported outcome measures were obtained at baseline and at 6-week, 3-, 6-, and 12-month follow-up. Radiographs and magnetic resonance imaging scans were obtained to evaluate joint degeneration and prosthesis location. The device alterations resolved the issues occurring with the previous design, but four prostheses were explanted after fixation failure or subluxation of the prosthesis. Five out of six patients who reached 1-year follow-up reported a clinically significant improvement of the knee injury and osteoarthritis outcome score pain subscale. Imaging revealed no adverse effects on joint degeneration. The failure mechanisms that occurred with the previous design have been resolved, but the new fixation technique introduced new safety issues. Improvement of positioning and fixation techniques are considered essential future adaptations to reduce the risk of failure. The good clinical outcomes reported by the patients reaching 1-year follow-up indicate that the medial meniscus prosthesis is a potential solution for patients suffering from postmeniscectomy pain syndrome. Level II.