Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2025-12-26 @ 2:10 AM
Study NCT ID:
NCT05676905
Status:
TERMINATED
Last Update Posted:
2025-01-31
First Post:
2022-11-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prospective Multicenter Observational Study on the Use of NEOCEMENT® for the Treatment of Bone Defects
Sponsor:
Bioceramed
Organization:
Study Overview
Official Title:
Prospective Multicenter Observational Study on the Use of NEOCEMENT® for the Treatment of Bone Defects
Status:
TERMINATED
Status Verified Date:
2024-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was terminated following a change in company management.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Neocement is a CE marked device, registered in INFARMED (Portuguese National Competent Authority) and Department of Planning and Organisation of the National Health Service - General board of Medical Devices, pharmaceutical services, and safety in healthcare (Italy). This protocol does not include any new intended uses, new populations, new materials or design changes.
Detailed Description:
Neocement developed by Bioceramed is a calcium phosphate cement, composed of a liquid and a solid phase that upon mixing form a mouldable paste which hardens within 4-8 minutes due to an isothermal reaction.
This device is intended to be used in filling bony voids or gaps in the extremities, which have either been surgically created, or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. Hence, it is intended to be used by healthcare professionals (surgeons) when bone ingrowth and consolidation are required.
Neocement is contraindicated to use in load bearing applications, and must not be used where the implantation site is unstable and not rigidly fixed. Additionally, it is also not indicated to use in cases where the implantation site presents infection, nor in cases where poor bone healing would be expected, such as metabolic, immunologic or systemic disorders.
Bone grafting technique has been employed for several decades by orthopaedic surgeons to potentiate the process of bone repair across all orthopaedics' subspecialties.
Despite autografts with cancellous bone being considered the "gold standard" for bone regeneration due to their osteogenic elements, there are numerous disadvantages associated to this technique, including extended surgical time, local pain and swelling from donor segments.
The use of synthetic substitutes, like calcium phosphate cements, have significant advantages, including decreased risk of infection from human pathogens, and unlimited availability in various shapes and sizes. Thus, reconstruction and/or filling of bone defects caused by trauma, disease, or tumour resection in long bones using calcium phosphate cements has proven to be an effective and safe alternative to reduce donor-site morbidity associated to autografting, whilst providing support for bone regeneration.
This device is intended to be used in filling bony voids or gaps in the extremities, which have either been surgically created, or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. Hence, it is intended to be used by healthcare professionals (surgeons) when bone ingrowth and consolidation are required.
Neocement is contraindicated to use in load bearing applications, and must not be used where the implantation site is unstable and not rigidly fixed. Additionally, it is also not indicated to use in cases where the implantation site presents infection, nor in cases where poor bone healing would be expected, such as metabolic, immunologic or systemic disorders.
Bone grafting technique has been employed for several decades by orthopaedic surgeons to potentiate the process of bone repair across all orthopaedics' subspecialties.
Despite autografts with cancellous bone being considered the "gold standard" for bone regeneration due to their osteogenic elements, there are numerous disadvantages associated to this technique, including extended surgical time, local pain and swelling from donor segments.
The use of synthetic substitutes, like calcium phosphate cements, have significant advantages, including decreased risk of infection from human pathogens, and unlimited availability in various shapes and sizes. Thus, reconstruction and/or filling of bone defects caused by trauma, disease, or tumour resection in long bones using calcium phosphate cements has proven to be an effective and safe alternative to reduce donor-site morbidity associated to autografting, whilst providing support for bone regeneration.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: