Bone CystBRBBTNCT02567084
Complete Twelve Month Bone Remodeling With a Bi-phasic Injectable Bone Substitute in Benign Bone Tumors
A study testing CERAMENT™ |BONE VOID FILLER in people with Bone Cyst, run by Poznan University of Medical Sciences.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 75 years
- Conditions the study is for
- Bone Cyst
- What is being tested?
- CERAMENT™ |BONE VOID FILLER
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- No sites listed yet
- Study dates
- Feb 2011to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients admitted to the hospital for surgical treatment of benign bone lesion requiring bone grafting.
Who cannot join
- 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).
About this study
Official title: 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.
Read the 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:
- Assess the ability of bi-phasic ceramic bone substitute to provide bone generation and bone remodeling in patients with benign bone tumors.
- Assess the safety of bi-phasic ceramic bone substitute as measured by device complaint/Adverse Events monitoring and documentation of subsequent surgical procedure.
- 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.
- Conditions
- Bone Cyst
- Being tested
- CERAMENT™ |BONE VOID FILLER
- Keywords
- Bone substitute, benign bone cyst, ceramic, remodelling
- Medical subject headings
- Bone Cysts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CERAMENT™ |BONE VOID FILLERDevice
Implantation of bi-phasic ceramic bone substitute to provide bone generation and bone remodeling in patients with benign bone tumors.
| Study group | Role | What they receive |
|---|---|---|
| CERAMENT™ |BONE VOID FILLER | Other | Intraoperativ application of medical device: CERAMENT™ |BONE VOID FILLER 5cc/10cc/18cc Receives: Device: CERAMENT™ |BONE VOID FILLER |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months after surgery
Secondary outcomes (2)
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.
Measured: 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.
Measured: 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2015 (estimated)
- Study startFeb 2011
- Primary completionDec 2013
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Bone CystStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poznan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, M.D Maciej Goch, Poznan University of Medical Sciences
- Investigators
- Jacek Kaczmarczyk, Prof.MD,PhD, Principal investigator, Poznan Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02567084
- Sponsor's protocol ID
- POZNAN-UMS-JK1
- Acronym
- BRBBT
- Status last verified
- Oct 2015
- First submitted
- 30 Sep 2015
- Last updated
- 2 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Mik G, Arkader A, Manteghi A, Dormans JP. Results of a minimally invasive technique for treatment of unicameral bone cysts. Clin Orthop Relat Res. 2009 Nov;467(11):2949-54. doi: 10.1007/s11999-009-1008-2. Epub 2009 Aug 4.
PubMed 19653053Khan SN, Tomin E, Lane JM. Clinical applications of bone graft substitutes. Orthop Clin North Am. 2000 Jul;31(3):389-98. doi: 10.1016/s0030-5898(05)70158-9.
PubMed 10882465Myeroff C, Archdeacon M. Autogenous bone graft: donor sites and techniques. J Bone Joint Surg Am. 2011 Dec 7;93(23):2227-36. doi: 10.2106/JBJS.J.01513.
PubMed 22159859Hinsenkamp M, Muylle L, Eastlund T, Fehily D, Noel L, Strong DM. Adverse reactions and events related to musculoskeletal allografts: reviewed by the World Health Organisation Project NOTIFY. Int Orthop. 2012 Mar;36(3):633-41. doi: 10.1007/s00264-011-1391-7. Epub 2011 Nov 3.
PubMed 22048753Lee GH, Khoury JG, Bell JE, Buckwalter JA. Adverse reactions to OsteoSet bone graft substitute, the incidence in a consecutive series. Iowa Orthop J. 2002;22:35-8.
PubMed 12180608Ferguson JY, Dudareva M, Riley ND, Stubbs D, Atkins BL, McNally MA. The use of a biodegradable antibiotic-loaded calcium sulphate carrier containing tobramycin for the treatment of chronic osteomyelitis: a series of 195 cases. Bone Joint J. 2014 Jun;96-B(6):829-36. doi: 10.1302/0301-620X.96B6.32756.
PubMed 24891586Reppenhagen S, Reichert JC, Rackwitz L, Rudert M, Raab P, Daculsi G, Noth U. Biphasic bone substitute and fibrin sealant for treatment of benign bone tumours and tumour-like lesions. Int Orthop. 2012 Jan;36(1):139-48. doi: 10.1007/s00264-011-1282-y. Epub 2011 May 28.
PubMed 21626113Fillingham YA, Lenart BA, Gitelis S. Function after injection of benign bone lesions with a bioceramic. Clin Orthop Relat Res. 2012 Jul;470(7):2014-20. doi: 10.1007/s11999-012-2251-5.
PubMed 22290129Petruskevicius J, Nielsen S, Kaalund S, Knudsen PR, Overgaard S. No effect of Osteoset, a bone graft substitute, on bone healing in humans: a prospective randomized double-blind study. Acta Orthop Scand. 2002 Oct;73(5):575-8. doi: 10.1080/000164702321022875.
PubMed 12440503Hatten HP Jr, Voor MJ. Bone healing using a bi-phasic ceramic bone substitute demonstrated in human vertebroplasty and with histology in a rabbit cancellous bone defect model. Interv Neuroradiol. 2012 Mar;18(1):105-13. doi: 10.1177/159101991201800114. Epub 2012 Mar 16.
PubMed 22440608Masala S, Nano G, Marcia S, Muto M, Fucci FP, Simonetti G. Osteoporotic vertebral compression fracture augmentation by injectable partly resorbable ceramic bone substitute (Cerament|SPINESUPPORT): a prospective nonrandomized study. Neuroradiology. 2012 Nov;54(11):1245-51. doi: 10.1007/s00234-012-1016-x. Epub 2012 Mar 6.
PubMed 22391680Abramo A, Geijer M, Kopylov P, Tagil M. Osteotomy of distal radius fracture malunion using a fast remodeling bone substitute consisting of calcium sulphate and calcium phosphate. J Biomed Mater Res B Appl Biomater. 2010 Jan;92(1):281-6. doi: 10.1002/jbm.b.31524.
PubMed 19904822Nilsson M, Zheng MH, Tagil M. The composite of hydroxyapatite and calcium sulphate: a review of preclinical evaluation and clinical applications. Expert Rev Med Devices. 2013 Sep;10(5):675-84. doi: 10.1586/17434440.2013.827529.
PubMed 24053255Sung AD, Anderson ME, Zurakowski D, Hornicek FJ, Gebhardt MC. Unicameral bone cyst: a retrospective study of three surgical treatments. Clin Orthop Relat Res. 2008 Oct;466(10):2519-26. doi: 10.1007/s11999-008-0407-0. Epub 2008 Aug 5.
PubMed 18679761Cho HS, Seo SH, Park SH, Park JH, Shin DS, Park IH. Minimal invasive surgery for unicameral bone cyst using demineralized bone matrix: a case series. BMC Musculoskelet Disord. 2012 Jul 29;13:134. doi: 10.1186/1471-2474-13-134.
PubMed 22839754
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Longitudinal Patient Study on CERAMENT™|BONE VOID FILLER in Benign Bone Tumors
- ClinicalTrials.gov ID
- NCT02567084
- Acronym / sponsor ID
- BRBBT / POZNAN-UMS-JK1
- Conditions
- Bone Cyst
- Keywords
- Bone substitute, benign bone cyst, ceramic, remodelling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Poznan University of Medical SciencesUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 2 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Assess the ability of bi-phasic ceramic bone substitute to provide bone generation and bone remodeling in patients with benign bone tumors.
- Assess the safety of bi-phasic ceramic bone substitute as measured by device complaint/Adverse Events monitoring and documentation of subsequent surgical procedure.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CERAMENT™ |BONE VOID FILLER | Other | Device: CERAMENT™ |BONE VOID FILLERIntraoperativ application of medical device: CERAMENT™ |BONE VOID FILLER 5cc/10cc/18cc |
Who may qualify
- Ages
- 7 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients admitted to the hospital for surgical treatment of benign bone lesion requiring bone grafting.
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CERAMENT™ |BONE VOID FILLERImplantation of bi-phasic ceramic bone substitute to provide bone generation and bone remodeling in patients with benign bone tumors. | Device | CERAMENT™ |BONE VOID FILLER |
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.
2 secondary outcomes
cyst and bone formation volume
Time frame: 12 months after surgery
adverse events
Time frame: 12 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2015.
- Background: PubMed 19653053Mik G, Arkader A, Manteghi A, Dormans JP. Results of a minimally invasive technique for treatment of unicameral bone cysts. Clin Orthop Relat Res. 2009 Nov;467(11):2949-54. doi: 10.1007/s11999-009-1008-2. Epub 2009 Aug 4.
- Background: PubMed 10882465Khan SN, Tomin E, Lane JM. Clinical applications of bone graft substitutes. Orthop Clin North Am. 2000 Jul;31(3):389-98. doi: 10.1016/s0030-5898(05)70158-9.
- Background: PubMed 22159859Myeroff C, Archdeacon M. Autogenous bone graft: donor sites and techniques. J Bone Joint Surg Am. 2011 Dec 7;93(23):2227-36. doi: 10.2106/JBJS.J.01513.
- Background: PubMed 22048753Hinsenkamp M, Muylle L, Eastlund T, Fehily D, Noel L, Strong DM. Adverse reactions and events related to musculoskeletal allografts: reviewed by the World Health Organisation Project NOTIFY. Int Orthop. 2012 Mar;36(3):633-41. doi: 10.1007/s00264-011-1391-7. Epub 2011 Nov 3.
- Background: PubMed 12180608Lee GH, Khoury JG, Bell JE, Buckwalter JA. Adverse reactions to OsteoSet bone graft substitute, the incidence in a consecutive series. Iowa Orthop J. 2002;22:35-8.
- Background: PubMed 24891586Ferguson JY, Dudareva M, Riley ND, Stubbs D, Atkins BL, McNally MA. The use of a biodegradable antibiotic-loaded calcium sulphate carrier containing tobramycin for the treatment of chronic osteomyelitis: a series of 195 cases. Bone Joint J. 2014 Jun;96-B(6):829-36. doi: 10.1302/0301-620X.96B6.32756.
- Background: PubMed 21626113Reppenhagen S, Reichert JC, Rackwitz L, Rudert M, Raab P, Daculsi G, Noth U. Biphasic bone substitute and fibrin sealant for treatment of benign bone tumours and tumour-like lesions. Int Orthop. 2012 Jan;36(1):139-48. doi: 10.1007/s00264-011-1282-y. Epub 2011 May 28.
- Background: PubMed 22290129Fillingham YA, Lenart BA, Gitelis S. Function after injection of benign bone lesions with a bioceramic. Clin Orthop Relat Res. 2012 Jul;470(7):2014-20. doi: 10.1007/s11999-012-2251-5.
- Background: PubMed 12440503Petruskevicius J, Nielsen S, Kaalund S, Knudsen PR, Overgaard S. No effect of Osteoset, a bone graft substitute, on bone healing in humans: a prospective randomized double-blind study. Acta Orthop Scand. 2002 Oct;73(5):575-8. doi: 10.1080/000164702321022875.
- Background: PubMed 22440608Hatten HP Jr, Voor MJ. Bone healing using a bi-phasic ceramic bone substitute demonstrated in human vertebroplasty and with histology in a rabbit cancellous bone defect model. Interv Neuroradiol. 2012 Mar;18(1):105-13. doi: 10.1177/159101991201800114. Epub 2012 Mar 16.
- Background: PubMed 22391680Masala S, Nano G, Marcia S, Muto M, Fucci FP, Simonetti G. Osteoporotic vertebral compression fracture augmentation by injectable partly resorbable ceramic bone substitute (Cerament|SPINESUPPORT): a prospective nonrandomized study. Neuroradiology. 2012 Nov;54(11):1245-51. doi: 10.1007/s00234-012-1016-x. Epub 2012 Mar 6.
- Background: PubMed 19904822Abramo A, Geijer M, Kopylov P, Tagil M. Osteotomy of distal radius fracture malunion using a fast remodeling bone substitute consisting of calcium sulphate and calcium phosphate. J Biomed Mater Res B Appl Biomater. 2010 Jan;92(1):281-6. doi: 10.1002/jbm.b.31524.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacek Kaczmarczyk, Prof.MD,PhD principal investigator
Poznan Medical University
Questions about this trial
What is this clinical trial studying?
A study testing CERAMENT™ |BONE VOID FILLER in people with Bone Cyst, run by Poznan University of Medical Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
bone remodeling according to Neer classification (time frame: 12 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02567084, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2015.