Clinical research
Translating computational models and algorithmic systems into clinically validated orthopedic interventions with transparent endpoints and reproducible analysis.
Prospective protocols evaluating orthopedic algorithms, implants, and rehabilitation systems.
NCT-OC-2025-001Evaluating whether AI-guided preoperative planning reduces implant positioning error below 1.5° RMSE compared with conventional templating.
Randomized controlled · Blinded outcome assessment · Intent-to-treat
Measuring predictive accuracy of patient-specific revision risk models using continuous wearable telemetry and hierarchical Bayesian calibration.
Prospective cohort · Wearable IMU telemetry · Bayesian hierarchical modeling
Assessing whether closed-loop force reflection reduces prosthetic motor adjustment errors by at least 40% in daily-use tasks.
Crossover design · EMG and force sensing · Signal processing validation
Confirming non-inferior osseointegration at twelve months versus titanium controls using micro-CT histomorphometry correlated to FEA models.
Multi-center RCT · Micro-CT histomorphometry · FEA-correlated outcomes
Standards that govern protocol design, data handling, and regulatory compliance.
All protocols are approved by institutional review boards. Informed consent follows ICH-GCP E6(R2) guidelines with adaptive designs pre-registered before enrollment.
Electronic data capture with audit trails, cryptographic hashing of raw streams, and FAIR-compliant metadata for reproducible analysis.
Trial designs align with FDA 21 CFR Part 11, EU MDR clinical evaluation requirements, and ISO 14155 good clinical practice.
Pre-specified analysis plans, multiplicity correction, Bayesian interim analyses, and external adjudication of primary endpoints.
Partnerships
Partner hospitals, investigators, and patient advocates are welcome to connect with our clinical affairs team about trial participation and research partnerships.
Response within two business days