Clinical Trial: Complete Twelve Month Bone Remodeling With a Bi-phasic Injectable Bone Substitute in Benign Bone Tumors

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Prospective, Longitudinal Patient Study on CERAMENT™|BONE VOID FILLER in Benign Bone Tumors

Brief 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 Summary:

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
Sponsor: Poznan University of Medical Sciences

Current Primary Outcome: bone remodeling according to Neer classification [ Time Frame: 12 months after surgery ]

Evaluate bone healing and remodeling at 12 month by X-ray and CT-scan using Modified Neer classification of radiological results.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • cyst and bone formation volume [ Time Frame: 12 months after surgery ]

    Calculate the pre-operative volume of the cyst, document the volume of product placed into the cyst and the volume of bone formed at 12 months.

    In the case of bone cysts assess the ability of CERAMENT™ |BONE VOID FILLER to transform into bone and possibly induce bone formation in regions of the cyst not filled with the product.

  • adverse events [ Time Frame: 12 months after surgery ]
    Assess the safety of CERAMENT™|BONE VOID FILLER as measured by number of any device complaint/Adverse Event and any subsequent surgical procedure.


Original Secondary Outcome: Same as current

Information By: Poznan University of Medical Sciences

Dates:
Date Received: September 30, 2015
Date Started: February 2011
Date Completion:
Last Updated: October 1, 2015
Last Verified: October 2015