Clinical trial · Interventional

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

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

NCT02567084CI-TRIAL-00019324BRBBTcompletedN/AClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Bone Cyst	—	UNRESOLVED	—

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
CERAMENT™ \|BONE VOID FILLER	Device	—	UNRESOLVED

Design

Arms and outcomes

Arms (1)

type
OTHER
label
CERAMENT™ |BONE VOID FILLER
description
Intraoperativ application of medical device: CERAMENT™ \|BONE VOID FILLER 5cc/10cc/18cc
interventionNames
1. Device: CERAMENT™ |BONE VOID FILLER

Primary outcomes (1)

measure
bone remodeling according to Neer classification
timeFrame
12 months after surgery
description
Evaluate bone healing and remodeling at 12 month by X-ray and CT-scan using Modified Neer classification of radiological results.

Secondary outcomes (2)

measure
cyst and bone formation volume
timeFrame
12 months after surgery

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 7 Years
Maximum age: 75 Years

Show eligibility criteria text

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).

References

Publications (18)

BACKGROUNDMik 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 19653053
BACKGROUNDKhan 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 10882465
BACKGROUNDMyeroff 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 22159859
BACKGROUNDHinsenkamp 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 22048753
BACKGROUNDLee 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 12180608
BACKGROUNDFerguson 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 24891586
BACKGROUNDReppenhagen 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 21626113