Pre-market Study to Evaluate Safety and Performance of GreenBone Implant

Multi-center, prospective, open-label, single-arm, first-in-human clinical investigation. The patient enrollment will be as follow: initial 5 patients enrolled at PI site. The other remaining patients will be enrolled in the three sites only after positive evaluation of the 3 months Follow Up (FU) interim report analysis by Data Safety Monitoring Board (DSMB). The Patients enrolled in this clinical investigation will undergo a scheduled surgery aiming to reconstruct iliac crest bone defect using GreenBone Implant. After surgery, the Patients will be monitored at pre-scheduled visits up to 6 months. The FU will be extended at 12 months only in case of no complete healing and/or in case of no resolved SAE at the 6 months FU visit. Adverse events, pain, quality of life and X-ray will be evaluated at scheduled follow-up visits. An independent DSMB will review the safety reports at regular intervals and Serious Adverse Events (SAE) as soon as reported, to protect Patients participating in the study. As specified before, an adaptive interim analysis will be performed when at least 5 Patients will have completed the 3 month follow up visit, (V5). The DSMB will review the results of the interim analysis with respect to the primary endpoint (safety) in order to continue the study up to 15 Patients.