Clinical trial NCT05676905: Prospective Multicenter Observational Study on the Use of NEOCEMENT® for the Treatment of Bone Defects
Official title: Prospective Multicenter Observational Study on the Use of NEOCEMENT® for the Treatment of Bone Defects
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Bone Deformity
Keywords: Bone cement
Observational study
Real-world study
Lead sponsor: Bioceramed
Sponsor class: INDUSTRY
Collaborators: name: European Clinical Research Infrastructure Network
name: Horizon 2020 - European Commission
First posted: 2023-01-09
Enrollment: 165
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Bone graft substitute patients who underwent surgery with Neocement and meet the eligibility criteria.

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.

Eligibility criteria: Inclusion Criteria:

* Patients with bone defect treatment who meet predefined criteria in Instructions For Use (IFU) of Neocement® / Neocement® Inject P.
* Age ≥ 18 years of both genders (male and female)
* Patient signed informed consent form (for data collection)
* Bone defects surgically created or osseous defects created from traumatic injury to the bone
* Bone skeletal defects that are not intrinsic to the stability of bone structure OR site which can be stabilized

Exclusion Criteria:

* Acute or chronic infection at the surgical site;
* Metabolic bone diseases;
* Severe degenerative disease conditions in which general bone grafting is not advisable;
* Active malignancy.
* Inability to understand consent and objectives of the study;
* Pregnant women or breastfeeding women;
* Unable to undergo medical monitoring for geographical, social or psychological reasons.

Primary outcomes:
measure: Bone consolidation (Neer/ RUST classification)
timeFrame: 24 months
Secondary outcomes:
measure: Functional scores
timeFrame: 24 months
Other outcomes:
measure: Adverse events
timeFrame: 24 months
measure: Quality of life measured through the SF-36 Questionnaire
timeFrame: 24 months
measure: Technical success rate
timeFrame: 24 months
Locations:
city: Lisboa
country: Portugal
facility: Centro Hospitalar Universitário de Lisboa Central
Study officials:
affiliation: Hospital Lusíadas Lisboa
name: Nuno Ribeiro, M. Doctor
role: STUDY_CHAIR
References: