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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 (CERAMENTâ„¢ |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 (CERAMENTâ„¢ 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CERAMENTâ„¢ |BONE VOID FILLER | Other | Intraoperativ application of medical device: CERAMENTâ„¢ |BONE VOID FILLER 5cc/10cc/18cc |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CERAMENTâ„¢ |BONE VOID FILLER | Device | Implantation of bi-phasic ceramic bone substitute to provide bone generation and bone remodeling in patients with benign bone tumors. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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 CERAMENTâ„¢ |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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jacek Kaczmarczyk, Prof.MD,PhD | Poznan Medical University | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19653053 | Background | 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. | |
| 10882465 | Background | Khan 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. |
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| ID | Term |
|---|---|
| D001845 | Bone Cysts |
| ID | Term |
|---|---|
| D003560 | Cysts |
| D009369 | Neoplasms |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| adverse events | Assess the safety of CERAMENTâ„¢|BONE VOID FILLER as measured by number of any device complaint/Adverse Event and any subsequent surgical procedure. | 12 months after surgery |
| 22159859 | Background | Myeroff 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. |
| 22048753 | Background | Hinsenkamp 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. |
| 12180608 | Background | Lee 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. |
| 24891586 | Background | Ferguson 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. |
| 21626113 | Background | Reppenhagen 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. |
| 22290129 | Background | Fillingham 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. |
| 12440503 | Background | Petruskevicius 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. |
| 22440608 | Background | Hatten 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. |
| 22391680 | Background | Masala 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. |
| 19904822 | Background | Abramo 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. |
| 24053255 | Background | Nilsson 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. |
| 18679761 | Background | Sung 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. |
| 22839754 | Background | Cho 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. |
| 2249537 | Background | Campanacci M, Capanna R, Fabbri N, Bettelli G. Curettage of giant cell tumor of bone. Reconstruction with subchondral grafts and cement. Chir Organi Mov. 1990;75(1 Suppl):212-3. No abstract available. |
| 10429612 | Background | Bickels J, Meller I, Shmookler BM, Malawer MM. The role and biology of cryosurgery in the treatment of bone tumors. A review. Acta Orthop Scand. 1999 Jun;70(3):308-15. doi: 10.3109/17453679908997814. |
| 26612576 | Derived | Kaczmarczyk J, Sowinski P, Goch M, Katulska K. Complete twelve month bone remodeling with a bi-phasic injectable bone substitute in benign bone tumors: a prospective pilot study. BMC Musculoskelet Disord. 2015 Nov 26;16:369. doi: 10.1186/s12891-015-0828-3. |