Pre-market Study to Evaluate Safety and Performance of GreenBone Implant
Condition: Bone Substitutes
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      This is a pre-market multi-centre, national, open label, single-arm, study to evaluate the
      safety and performance of a Class III medical device (GreenBone Implant) for iliac crest
      reconstruction following bone graft harvesting for pelvic fusion. During pelvic fusion a
      considerable part of the iliac crest is removed and it is used as autologous bone graft for
      the fusion of the pubis symphysis. The bone defect that is formed in the iliac crest is
      usually filled with bone obtained from the cows (bovine xenograft) and or human donors
      (allograft). This carries the risk of transferring disease from animals and/or humans to the
      patient; there is also a risk of host local allergic reaction. Bone substitutes are devoid of
      the above risks and therefore they could be used alternatively to xenografts and allografts.

      GreenBone is a ceramic resorbable bone scaffold that has very similar structure to bone. It
      can be produced in large quantities, shaped easily and sterilised without losing its
      properties. Consequently, it is an ideal substitute that could be used to fill bone defects.
      This study will assess the safety of using GreenBone to reconstruct iliac crest defects.
      Moreover it will assess its capacity of promoting new bone formation. The investigators will
      recruit 15 patients who will undergo pelvic fusion and instead of bovine xenograft the
      investigators will use the GreenBone implant for the iliac crest reconstruction.

      Patients will be followed up for 6 months in total. Safety will be evaluated by monitoring
      local and potential systemic reactions; its bone forming capacity will also be assessed by
      its integration into the iliac crest.
    

Intervention name(s): Iliac crest reconstruction surgery
Intervention type(s): Device
Intervention description(s): When autologous bone graft is needed for the treatment of non-unions or bone defects, is harvested from the pelvic iliac crest. Harvested tricortical graft blocks are used to facilitate fusion of joints (ie pubis symphysis, sacroiliac joint), to structurally support metaphyseal areas of articular impaction injuries and to fill in metaphyseal bone voids. The GreenBone device, with its inherent physical and biomimic properties, possesses similar structural properties to bone, thus, being the ideal material to be used for the treatment of the bone defect (3- 4cm) induced from the harvested tricortical iliac crest, restoring therefore the pelvic anatomy and minimising the risk of chronic pain, haematoma formation and herniation of the abdominal contents.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Bone substitute; Bone regeneration