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

Bone Cyst Clinical Trial

— BRBBT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02567084
• Other study ID #: POZNAN-UMS-JK1
• Status: Completed
• Phase: N/A
• First received: September 30, 2015
• Last updated: October 1, 2015
• Start date: February 2011
• Est. completion date: December 2014

Study information

• Verified date: October 2015
• Source: Poznan University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ethics Committee
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: December 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years to 75 Years

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bone Cyst
• Bone Cysts

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Poznan University of Medical Sciences

References & Publications (17)

Abramo A, Geijer M, Kopylov P, Tägil 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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Epub 2012 Mar 16. — View Citation

Hinsenkamp M, Muylle L, Eastlund T, Fehily D, Noël 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. Review. — View Citation

Khan SN, Tomin E, Lane JM. Clinical applications of bone graft substitutes. Orthop Clin North Am. 2000 Jul;31(3):389-98. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

Nilsson M, Zheng MH, Tägil 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. Review. Erratum in: Expert Rev Med Devices. 2013 Nov;10(6):857. — View Citation

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. — View Citation

Reppenhagen S, Reichert JC, Rackwitz L, Rudert M, Raab P, Daculsi G, Nöth 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. — View Citation

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. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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.	12 months after surgery	No
Secondary	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.	12 months after surgery	Yes