An interventional study of CERAMENT™ |BONE VOID FILLER in Bone Cyst, sponsored by Poznan University of Medical Sciences. Completed. Open to participants aged 7 Years to 75 Years. Per ClinicalTrials.gov, last updated 2015-10-02.
Sponsored by Poznan University of Medical Sciences · Not applicable, Interventional, and Treatment
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:
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.
18 studies on the registry are indexed under Bone Cysts; 5 are open to participants now.
This study's enrollment of 14 is below the median of 17 across 10 interventional studies indexed under Bone Cysts.
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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.
bone remodeling according to Neer classification
Evaluate bone healing and remodeling at 12 month by X-ray and CT-scan using Modified Neer classification of radiological results.
Time frame: 12 months after surgery
cyst and bone formation volume
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.
Time frame: 12 months after surgery
adverse events
Assess the safety of CERAMENT™\|BONE VOID FILLER as measured by number of any device complaint/Adverse Event and any subsequent surgical procedure.
Time frame: 12 months after surgery
No study locations are listed for this record.
The record gives a start of Feb 2011, a primary completion of Dec 2013 and a completion of Dec 2014. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.
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Poznan University of Medical Sciences →