Neocement® for repairing bone defects: safety and performance in adults

Evaluation of the Safety and Performance of the Neocement®: A Prospective Observational Study in Orthopaedic Area

This study will test Neocement®, a resorbable calcium phosphate bone cement, in adults having surgery for bone defects to see if it is safe and performs well during and after the procedure.

Quick facts

• Study type: Observational
• Enrollment: 80 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Bioceramed (industry)
• Locations: 1 site (Barcelos)
• Trial ID: NCT06973226 on ClinicalTrials.gov

What this trial studies

This is a prospective, observational post-market study collecting real-world clinical data on Neocement® when used according to its instructions for use in adult patients with bone defects. Neocement® is a Class III calcium phosphate cement combined with chitosan, intended for long-term implantation and expected to be partially or totally resorbed within about six months. Participating orthopedic surgeons will use the device in routine surgical care and patients will be followed for clinical performance and safety outcomes. The collected data will support the device's clinical evaluation for regulatory submission under EU MDR 2017/745.

Who should consider this trial

Good fit: Adults (over 18) with bone defects suitable for augmentation who meet the device's Instructions For Use, have a site that can be stabilized, and can give informed consent are ideal candidates.

Not a fit: Patients with local or systemic infection, metabolic bone disorders, unstable or load-bearing defects requiring structural support, or who cannot consent are unlikely to benefit from this device.

Why it matters

Potential benefit: If successful, Neocement® could provide a resorbable bone filler that supports bone regeneration while reducing the need for other graft materials.

How similar studies have performed: Related calcium phosphate bone cements have shown positive clinical results, but clinical evidence specific to this Neocement® formulation is limited and is being collected in this study.

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®;
* 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.

Where this trial is running

Barcelos

• Unidade Local de Saúde Esposende/Barcelos — Barcelos, Portugal (RECRUITING)

Study contacts

• Study coordinator: Alexandre Barros

Conditions: Bone Defects, Orthopaedic Surgery, Neocement®, prospective observational clinical study, medical device, performance and safety, bone defects, real-world clinical data