Complete Twelve Month Bone Remodeling With a Bi-phasic Injectable Bone Substitute in Benign Bone Tumors
Condition: Bone Cyst
MeSH terms: Bone Cysts
Study type: Interventional

Summary: 
      The purpose of this study is to assess the ability a injectable bi-phasic ceramic bone
      substitute to provide bone generation and bone remodeling in patients with benign bone
      tumors.
    

Detailed description: 
      The aim of the study is to assess the usefulness of injectable bi-phasic ceramic bone
      substitute (CERAMENT™ |BONE VOID FILLER) in patients with benign bone tumors. The primary
      objectives is to:

        1. Assess the ability of bi-phasic ceramic bone substitute to provide bone generation and
           bone remodeling in patients with benign bone tumors.

        2. Assess the safety of bi-phasic ceramic bone substitute as measured by device
           complaint/Adverse Events monitoring and documentation of subsequent surgical procedure.

        3. In the case of bone cysts assess the ability of bi-phasic ceramic bone substitute to
           transform into bone and possibly induce bone formation in regions of the cyst not filled
           with the product.

      Benign bone tumors are often treated with intralesional curettage which creates a bone defect
      that can be filled with e.g. demineralized bone matrix, autologous bone, ceramic bone
      substitutes or polymethylmetacrylate cement.

      Autograft has been considered the golden standard because it possesses all three of the
      essential elements required for an optimal bone graft, but is associated with morbidity at
      the donor site and is limited in supply. Allograft has been employed as a good alternative to
      autograft but the concern for potential disease transmission remains. Synthetic bone graft
      substitutes have been gaining popularity as viable alternatives for void and defect filling
      eliminating the concerns with autograft and allograft. These synthetic bone substitutes have
      invariably been based on calcium phosphate and/or calcium sulfate materials which are
      osteoconductive and facilitate bone remodeling, although side effects such as drainage and
      wound complications slow remodeling to bone or negligible bone generation have limited their
      use. Thus, new synthetic bone substitutes with described positive effects in vertebroplasty,
      osteotomy, and smaller trauma defects merit further investigation also in treatment of larger
      bone defects.

      In a prospective series, patients with benign bone tumors were treated by minimal invasive
      intervention with a bi-phasic and injectable ceramic bone substitute (CERAMENT™ BONE VOID
      FILLER), composed of 60% weight synthetic calcium sulfate (CaS) and 40% weight hydroxyapatite
      (HA) powder was mixed with a water-soluble radio-contrast agent iohexol (180 mg/ml) to make
      the material radiopaque. The defects were treated by either mini-invasive surgery (solid
      tumors) or percutaneous injection (cysts) and followed clinically and radiologically for 12
      months. CT scan was performed after 12 months to confirm bone remodeling of the bone
      substitute. All patients were allowed full weight bearing immediately after surgery.
    

Intervention name(s): CERAMENT™ |BONE VOID FILLER
Intervention type(s): Device
Intervention description(s): Implantation of bi-phasic ceramic bone substitute to provide bone generation and bone remodeling in patients with benign bone tumors.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bone substitute; benign bone cyst; ceramic; remodelling