Fig. 1

Study design. ¹A second set of X-ray images could have been performed 1 month later during screening if pre-study images were not available; ²if CT scan and/or X-ray of less than 2 weeks at the time of screening were available and of sufficient quality, they could have been used as baseline images; ³GDE by both patient and physician; ⁴GDE by the patient only; ⁵GDE by the investigator; ⁶visual analogue scale; ⁷Likert scale; ⁸weight-bearing score (Likert scale); ⁹blood sampling for the biomarkers and auto-immunity using the blood sampling kits (in the initiation kit); ¹⁰evaluated before implantation and 24 and 48 h post-implantation. W, weeks; M, months; EoS, end of the study; D, days; CT, computed tomography; GDE; Global Disease Evaluation; AE, adverse event; SAE, serious adverse event. The dashed line represents the long-term safety follow-up period