Complete Twelve Month Bone Remodeling With a Bi-phasic Injectable Bone Substitute in Benign Bone Tumors
Complete Twelve Month Bone Remodeling With a Bi-phasic Injectable Bone Substitute in Benign Bone Tumors
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.
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.
Inclusion Criteria:

 -  Patients admitted to the hospital for surgical treatment of benign bone lesion
 requiring bone grafting.

 Exclusion Criteria:

 -  Patient below 6 years of ageIrreversible coagulopathy or bleeding disorder. Note
 regarding reversible coagulopathies: Patients on coumarin or other anticoagulants may
 participate. Investigators should follow routine practices for perioperative
 discontinuation and re-initiation of anticoagulants;

 -  A pre-existing calcium metabolism disorder (e.g. hypercalcemia).