Prospective Multicenter Observational Study on the Use of NEOCEMENT® for the Treatment of Bone Defects

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.

Study Overview

• Status: Terminated
• Conditions: Bone Deformity
• Intervention / Treatment: Device: Neocement

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.

• Study Type: Observational
• Enrollment (Actual): 165

Contacts and Locations

Study Locations

• Portugal
  • Lisboa, Portugal
    • Centro Hospitalar Universitário de Lisboa Central

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Bone graft substitute patients who underwent surgery with Neocement and meet the eligibility criteria.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bone consolidation (Neer/ RUST classification)	Neer classification is used for trabecular bone: Healed: Cyst filled by new bone, with or without small radiolucent area(s) < 1 cm in size Healing with defects: Radiolucent area(s) < 50% of the diameter of bone, with enough cortical thickness to prevent fracture Persistent cyst: Radiolucent area > 50% of diameter of the bone and with a thin cortical rim. No increase in the size of the cyst. Recurrent cyst: Cyst reappeared in a previously obliterated area, or a residual radiolucent area has increased in size) RUST is classified according to the scores: Score 1: Fracture Line, No Callus Score 2: Fracture Line, Visible Callus Score 3: Fracture Line, Bridging Callus Score 4: No fracture line, remodelled	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional scores	Functional scores are classified as Hip disability and Osteoarthritis Outcome Score, Knee disability and Osteoarthritis Outcome Score, Foot and Ankle Ability Measure, where 0 points is the worst possible score and 100 points is the best possible score.	24 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	Assess patients' health during recovery	24 months
Quality of life measured through the SF-36 Questionnaire	Collect usability feedback on the device	24 months
Technical success rate	Successful delivery of the bone substitute in the bone defect	24 months

Collaborators and Investigators

• Sponsor: Bioceramed
• Collaborators: Horizon 2020 - European Commission; European Clinical Research Infrastructure Network
• Investigators: Study Chair: Nuno Ribeiro, M. Doctor, Hospital Lusíadas Lisboa

Study record dates

Study Major Dates

• Study Start (Actual): November 6, 2024
• Primary Completion (Actual): November 6, 2024
• Study Completion (Actual): November 6, 2024

Study Registration Dates

• First Submitted: November 28, 2022
• First Submitted That Met QC Criteria: January 6, 2023
• First Posted (Actual): January 9, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 29, 2025
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Observational study; Bone cement; Real-world study
• Additional Relevant MeSH Terms: Congenital Abnormalities
• Other Study ID Numbers: TBMED1.1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No