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Kinematic Alignment (KA) in Total Knee Arthroplasty (TKA) has emerged as a patient-specific alternative to the long-standing Mechanical Alignment (MA) approach. While KA aims to restore the native, pre-arthritic joint lines and rotational axes of each patient’s knee — promising a more natural-feeling joint and quicker recovery — its adoption has been slow. The hesitation stems largely from limited high-quality, long-term randomized controlled trial (RCT) data, conflicting clinical evidence, and questions around real-world applicability.Meta-analyses of existing RCTs often find no clinically important difference in patient-reported outcomes between KA and MA, and many of these trials carry moderate-to-high risks of bias with average follow-ups of just 24 months — far short of the 15–20 years implants are expected to last. This has left unanswered critical questions about implant longevity, revision rates, complication profiles, and the impact of surgeon experience on outcomes.The Circles platform offers a breakthrough solution to this evidence gap by generating high-quality, verifiable, and complete Real-World Evidence (RWE). Unlike traditional ‘big data’ sources — which often contain gaps, unverifiable origins, and inconsistent clinical context — Circles collect time-stamped, unmanipulated data directly from physicians, patients, and laboratories, all within closed Observational Protocols (OPs). These protocols adhere to Good Clinical Practice (GCP) standards and are designed to capture data across the full patient journey, from enrollment to long-term outcomes.For KA in TKA, Circles can design OPs to address the most pressing evidence gaps:Longitudinal comparative effectiveness of KA vs. MA, capturing nuanced patient satisfaction metrics like the Forgotten Joint Score (FJS) alongside implant survivorship data extending beyond a decade.Impact of enabling technologies, such as robotics and compartmental pressure sensors, on surgical precision, learning curves, complication rates, and functional recovery.Correlation of objective kinematics (e.g., gait analysis, wearable sensors) with subjective outcomes, helping bridge the disconnect between biomechanical metrics and patient perception.Real-world complication tracking, including ligament releases, recuts, and intra-operative injuries, validating or refining KA’s “ligament sparing” claims.By integrating advanced data streams — preoperative imaging, intraoperative precision metrics, postoperative kinematics — Circles can effectively create a ‘digital twin’ for each knee replacement. This allows unprecedented insight into how surgical precision translates to real-world function and satisfaction.The platform’s transparent methodology also supports best-practice development by analyzing performance variability across surgeons, institutions, and patient demographics. This is particularly important for KA, where surgeon experience and patient selection may significantly influence results.In a field where the stakes include decades of patient mobility and quality of life, Circles provide an agile, scalable, and scientifically rigorous way to build the evidence base that KA needs. By closing critical data gaps, they can accelerate responsible adoption, refine surgical training, and ultimately improve outcomes for TKA patients worldwide.

Total Knee Arthroplasty (TKA) is a life-changing intervention for patients with end-stage knee osteoarthritis. With over 600,000 procedures performed annually in the U.S. — and projected to rise nearly sevenfold by 2030—its impact is profound. Yet, despite the success of conventional techniques, up to a quarter of patients remain dissatisfied, often due to the inability to fully replicate the natural motion of the knee.The emergence of Robotic-Assisted TKA (RA-TKA) promises unprecedented precision in implant placement and alignment, with the aim of improving patient satisfaction and long-term implant survivorship. But the technology’s adoption is slowed by unresolved debates, inconsistent outcomes data, and the high financial burden of robotic systems. The orthopedic community continues to grapple with critical questions:Does RA-TKA truly deliver superior patient-perceived benefits in the long term?Is kinematic alignment (KA) better than mechanical alignment (MA)?Can the costs and learning curve be justified by measurable improvements in outcomes?Randomized Controlled Trials (RCTs) are the gold standard for evaluating surgical interventions, but they have limitations in real-world applicability due to controlled environments and narrow patient selection. Real-World Evidence (RWE) fills this gap, capturing data from routine clinical practice.However, traditional “big data” RWE sources — derived from EMRs, registries, and insurance claims — are often incomplete, unverifiable, and lack the longitudinal follow-up needed for meaningful conclusions. These shortcomings hinder the ability to answer pressing RA-TKA questions, particularly around alignment strategies, implant longevity, and cost-effectiveness.RegenMed’s Circles platform is engineered to address these evidence gaps with a methodology that mirrors the rigor of clinical trials while maintaining the practicality of real-world data collection.Key Features:Direct, Verifiable Data Sourcing: Information comes straight from physicians, patients, and laboratories, each datapoint time-stamped and immutable.Longitudinal Case Tracking: Every dataset follows a complete patient journey, from enrollment through long-term outcomes, capturing critical measures like implant survivorship and patient satisfaction.Driven Relevance: Each dataset is tied to a specific Observational Protocol (OP) for targeted, clinically meaningful insights—such as robotic KA vs. MA comparisons.Good Clinical Practice (GCP) Compliance: The platform inherently supports ethical and regulatory standards, including IRB processes and patient consent.Equitable Ownership and Benefits: Circle members retain data ownership and can receive up to 85% of licensing value, incentivizing participation.Solving RA-TKA’s Evidence Challenges:Quality and Verifiability: Circles eliminates the ambiguity of traditional datasets, enabling robust comparative studies of alignment strategies and robotic platforms.Long-Term Outcomes: Continuous data capture supports proactive monitoring of implant performance, complications, and evolving patient satisfaction.Cost-Effectiveness: Granular, structured data allows detailed economic analyses, critical in evaluating the true return on investment of robotic systems.Surgeon Learning Curve: Performance tracking over time can inform training programs and credentialing standards.Patient-Reported Outcomes (PROMs): High-fidelity capture ensures the patient’s voice is central in assessing surgical success.Robotic-assisted knee replacement holds tremendous promise, but the orthopedic field needs better answers before widespread adoption. Circles provides the framework to generate those answers — efficiently, cost-effectively, and with clinical rigor. By combining the precision of RA-TKA with the precision of high-quality RWE, Circles can guide technology adoption, resolve long-standing debates, and improve patient outcomes at scale.

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Are you a podiatry specialist looking to elevate your clinical practice through data ownership, collaboration, and innovation? RegenMed proudly introduces the Shockwave Podiatry Circles — a physician-owned community designed exclusively for podiatry specialists. Led by industry experts like Nathan Ivey, Owner of New Mexico Foot & Ankle Institute, and Kurt Relation, a board-certified Podiatric Surgeon and owner of Bluestone Podiatry in Slingerlands, NY, it has already demonstrated promising results over the past 3 months. ‍Why join the Shockwave Podiatry Circle? Full ownership and governance of your clinical dataActionable clinical and financial insights to grow your practiceCollaborative opportunities within a focused, expert communityAccess to real-world evidence that advances podiatric careMark your calendar: Our upcoming Circle Hour scheduled for early October — a dedicated session to analyze the latest data and outcomes, share insights, and discuss the future of Shockwave therapy in podiatry. Interested? ‍Reach out today to learn more and secure your spot: https://www.rgnmed.com/circle-library/foot-and-ankle-plantar-fasciitis-shockwave-vas-ffi

The Power of Internally Generated EvidenceIn the quest to improve outcomes in total knee (TKA) and total hip arthroplasty (THA), Real-World Evidence (RWE) has become indispensable. However, the traditional sources of RWE — claims databases, generalized EHRs, and broad registries — often suffer from data quality issues, inconsistent definitions, and limited traceability. RegenMed’s TKA and THA Circles utilize a closed data system that captures, validates, and leverages high-quality data generated entirely within the care ecosystem. This ensures unambiguous ownership by the provider group of all data, along with its attendant clinical and financial value.Circles focus on internal validity over generalizability. Instead of aggregating disparate data sources, they efficiently capture detailed clinician entries, directly reported patient outcomes, and validated device data within a singular, controlled environment. The result is highly trusted, clinically actionable evidence that enables precise quality improvement and local innovation.Data That Drives ImprovementCircles collect a rich spectrum of data directly at the source. From granular surgical technique details and implant identifiers to validated Patient-Reported Outcome Measures (PROMs), the system ensures every data point is structured, time-stamped, and contextually relevant. Examples include:‍‍Clinician-entered details: surgical approach, anesthesia type, implant lot numbers, and intraoperative events.‍Patient-reported outcomes: pain and function scores (e.g., KOOS JR, HOOS JR), satisfaction, and health literacy, collected via tablets, portals, or mobile apps.Device integration: metrics like range of motion or activity levels from validated wearables and intraoperative sensors.Critically, all data flows through validation checkpoints — automated rules, structured forms, and internal audits — to maintain integrity. This allows for nuanced analysis of surgical techniques, implant performance, patient subgroups, and care pathways.Applications Within the SystemThe true strength of closed-system RWE lies in its targeted application. It empowers:Surgeon and site benchmarking: Enabling risk-adjusted comparisons of PROMs, complications, and revisions.Comparative effectiveness: Studying local outcomes from different implants, approaches, or protocols.Longitudinal outcome tracking: Understanding patient recovery trajectories and long-term implant performance.Personalized care: Using AI/ML models to predict outcomes, stratify risk, and inform shared decision-making based on system-specific data.Moreover, RegenMed’s TKA and THA Circles foster continuous improvement by linking outcomes to care practices. For example, PROM data can inform refinements in perioperative protocols, while validated device metrics can enhance rehabilitation pathways.Navigating Limitations with TransparencyCircles offer precision and trust — but with trade-offs. Because a single provider’s findings apply primarily to its own population and practice environment, generalizability is limited. Circles address these challenges by supporting broad participation in the same TKA or THA Observational Protocol by any type of provider – academic medical centers, independent provider groups and even sole practitioners — wherever located in the world. ConclusionRegenMed’s THA and TKA Circles represent a forward-thinking strategy to generate clinically meaningful RWE for orthopedic procedures. They are essential to genuine value-based care environments. By focusing on internal data integrity and application, they provide a blueprint for organizations seeking to enhance surgical outcomes, personalize patient care, and lead with data-driven precision—all from within their own ecosystem.