All eligible participants who provided informed consent were included in the study. Participants who refused HeRO Graft implantation, or did not have the HeRO Graft implanted for any other reason, were followed in the control group. Several patients did not receive the HeRO graft due to anatomical challenges and failure to complete both steps of the two-stage implant procedure. All consented participants who had an implanted HeRO Graft were followed in the study group. All participants were followed until the study end, withdrawal, loss to follow-up, or death. The analysis included only HeRO Graft patients and control patients who were not lost to follow-up; patients who were lost to follow-up, before data collection, were excluded from analysis.