Complete Twelve Month Bone Remodeling With a Bi-phasic Injectable Bone Substitute in Benign Bone Tumors (BRBBT)

October 1, 2015 updated by: M.D Maciej Goch, Poznan University of Medical Sciences

A Prospective, Longitudinal Patient Study on CERAMENT™|BONE VOID FILLER 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 71 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: CERAMENT™ |BONE VOID FILLER
Intraoperativ application of medical device: CERAMENT™ |BONE VOID FILLER 5cc/10cc/18cc
Device: CERAMENT™ |BONE VOID FILLER
Implantation of bi-phasic ceramic bone substitute to provide bone generation and bone remodeling in patients with benign bone tumors.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months after surgery
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.
12 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Poznan University of Medical Sciences

Investigators

  • Principal Investigator: Jacek Kaczmarczyk, Prof.MD,PhD, Poznan Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

September 30, 2015

First Submitted That Met QC Criteria

October 1, 2015

First Posted (Estimate)

October 2, 2015

Study Record Updates

Last Update Posted (Estimate)

October 2, 2015

Last Update Submitted That Met QC Criteria

October 1, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • POZNAN-UMS-JK1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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