NCT02567084

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2011

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 30, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 2, 2015

Completed
Last Updated

October 2, 2015

Status Verified

October 1, 2015

Enrollment Period

2.8 years

First QC Date

September 30, 2015

Last Update Submit

October 1, 2015

Conditions

Bone Cyst

Keywords

Bone substitutebenign bone cystceramicremodelling

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • cyst and bone formation volume

    12 months after surgery

  • adverse events

    12 months after surgery

Study Arms (1)

CERAMENT™ |BONE VOID FILLER

OTHER

Intraoperativ application of medical device: CERAMENT™ \|BONE VOID FILLER 5cc/10cc/18cc

Device: CERAMENT™ |BONE VOID FILLER

Interventions

CERAMENT™ |BONE VOID FILLERDEVICE

Implantation of bi-phasic ceramic bone substitute to provide bone generation and bone remodeling in patients with benign bone tumors.

CERAMENT™ |BONE VOID FILLER

Eligibility Criteria

Age7 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients admitted to the hospital for surgical treatment of benign bone lesion requiring bone grafting.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (18)

  • 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.

    PMID: 19653053BACKGROUND

  • 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.

    PMID: 10882465BACKGROUND

  • 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.

    PMID: 22159859BACKGROUND

  • 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.

    PMID: 22048753BACKGROUND

  • 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.

    PMID: 12180608BACKGROUND

  • 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.

    PMID: 24891586BACKGROUND

  • 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.

    PMID: 21626113BACKGROUND

  • 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.

    PMID: 22290129BACKGROUND

  • 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.

    PMID: 12440503BACKGROUND

  • 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.

    PMID: 22440608BACKGROUND

  • 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.

    PMID: 22391680BACKGROUND

  • 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.

    PMID: 19904822BACKGROUND

  • 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.

    PMID: 24053255BACKGROUND

  • 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.

    PMID: 18679761BACKGROUND

  • 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.

    PMID: 22839754BACKGROUND

  • 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.

    PMID: 2249537BACKGROUND

  • 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.

    PMID: 10429612BACKGROUND

  • 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.

    PMID: 26612576DERIVED

MeSH Terms

Conditions

Bone Cysts

Condition Hierarchy (Ancestors)

CystsNeoplasmsBone DiseasesMusculoskeletal Diseases

Study Officials

  • Jacek Kaczmarczyk, Prof.MD,PhD

    Poznan Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 30, 2015

First Posted

October 2, 2015

Study Start

February 1, 2011

Primary Completion

December 1, 2013

Study Completion

December 1, 2014

Last Updated

October 2, 2015

Record last verified: 2015-10