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.

Contact us to learn more.