Evaluation of the Safety and Performance of the Neocement® Inject P

NCT ID: NCT06973239

Last Updated: 2025-10-02

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-09-05
• Study Completion Date: 2027-06-30

Brief Summary

This study aims to collect real-world clinical data to gather information on the performance and safety of the Neocement® Inject P when used according to its intended purpose and current clinical applications. The results of the clinical study will serve as clinical evidence for the device's clinical evaluation, targeting submission to the new Medical Device Regulation (EU) 2017/745.

Detailed Description

Neocement® Inject P represents a breakthrough in orthopaedic biomaterials, meticulously engineered to enhance bone repair and regeneration. This synthetic bone substitute combines tetracalcium phosphate and beta-tricalcium phosphate within its P-system architecture, augmented by chitosan and an aqueous solution enriched with citric acid and glucose.

Neocement® Inject P is indicated for filling bony voids or gaps of the skeletal system that are not intrinsic to the stability of the bony structure. The device may be used for filling surgically created bone defects or osseous defects created from traumatic injury to the bone.

To achieve its intended purpose, Neocement® Inject P will be placed in contact with bone tissue and surrounding tissues by surgically invasive techniques in operating rooms. More than one unit of Neocement® Inject P can be used for filling bony voids or gaps of the skeletal system, depending on the lesion.

Neocement® Inject P is a class III medical device. This advanced biomaterial offers a reliable solution for addressing bone fractures and loss, demonstrating significant potential in enhancing patient outcomes through accelerated and durable bone regeneration. Neocement® Inject P is expected to be partially or totally resorbed, from the clinical available data, the expected effect can be predicted to occur after 6 months.

This observational post-market study will collect data relating to standard practice procedures, therefore there are no additional risks or direct benefits associated with participating in this registry for the patient.

This study based on observations of clinical practice aims to collect clinical data to keep up to date the information on the performance and safety of the medical device when used in accordance with its intended use and current clinical applications. The results of the clinical study shall be used as clinical evidence for clinical evaluation of the device aiming submission to the new Medical Device Regulation (EU) 2017/745.

The post-market study is meant to identify and analyse emerging risks, ensure the continued acceptability of the benefit/risk ratio and also identify possible systematic misuse or unauthorized use of the medical device. This protocol does not include any planned new uses, new populations, new materials or design changes.

The results from the prospective observational post-market study will provide an evidence base for assessing the device's performance and safety after its market launch. Detecting real discrepancies in clinical performance between of the medical device early on can offer valuable opportunities to improve device design. This complements the data collected during the pre-market phases, thus improving patient selection. Active surveillance of the safety of medical devices, achieved through the continuous monitoring of vast sources of clinical data, is a priority in the field of medical devices, a requirement of MDR regulation No. 2017/745. This approach is crucial to achieving the objectives set, guaranteeing the safety and performance of the devices in circulation.

Patients will be followed as per local standard medical practices of the centre for 1 year.

Clinical data will be collected at 5 points in time: Visit 1 (15 ±2 days after surgery - baseline and enrolment), Visit 2 (6 weeks ±1 week), Visit 3 (3 months ±3 weeks), Visit 4 (6 months ±3 weeks) and if necessary, a Visit 5 (12 months ±30 days).

Conditions

Bone Defects; Orthopaedic Surgery (30 Minutes or Longer)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Adult males or females (age > 18 years old);
• Patients with bone defect treatment who meet predefined criteria in Instructions For Use (IFU) of Neocement® Inject P;
• Patients who are able to sign an informed consent form (for data collection)
• Patients with bone defects, which may be surgically created or result from traumatic injury to the bone;
• Patients with bone skeletal defects that are not intrinsic to the stability of the bone structure or with a site that can be stabilized;

Exclusion Criteria

• Patients who are unable to understand consent and the objectives of the study;
• Signs of local or systemic acute/ active or chronic infections;
• Metabolic affections;
• Severe degenerative diseases, conditions in which general bone grafting is not advisable;
• Implementation sites that allow product migration;
• Conditions which require structural support in the skeletal system;
• Conditions where the implantation site is unstable and not rigidly fixated;
• Sensibility to the implantable materials;
• Known hypersensitivity to the implant material.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Local Health Unit Barcelos/Esposende, Public Health Unit

OTHER_GOV

Sponsor Role: collaborator

Bioceramed

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Unidade Local de Saúde Esposende/Barcelos

Barcelos, , Portugal

Site Status: RECRUITING

Countries

Portugal

Central Contacts

Alexandre Barros

Role: CONTACT

clinicalstudies@bioceramed.com

(+351) 253 573 460 ext. +351

Facility Contacts

Bruno Pereira

Role: primary

secadm@hbarcelos.min-saude.pt

(+351) 253 809 200 ext. +351

Other Identifiers

NeocementInject01

Identifier Type: -

Identifier Source: org_study_id