Neocement® Inject P to fill bone defects and support bone repair

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

We will try Neocement® Inject P, a synthetic bone filler used during orthopedic surgery, in adults with surgically created or traumatic bone defects to see if it helps bone repair and is safe.

Quick facts

• Study type: Observational
• Enrollment: 80 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Bioceramed (Industry-sponsored)
• Locations: 1 site (Barcelos)
• Trial ID: NCT06973239 on ClinicalTrials.gov

What this trial studies

This observational post‑market study will collect real‑world data from adults who receive Neocement® Inject P according to the device Instructions for Use during routine orthopedic procedures. The device, a tetracalcium phosphate and beta‑tricalcium phosphate composite with chitosan, will be implanted into non‑load‑bearing bone voids or gaps and patients will be followed per standard clinical practice. No additional experimental interventions are planned beyond normal surgical care and routine follow‑up, and more than one unit may be used when clinically needed. Data collected will focus on device performance, safety outcomes, and resorption behavior over the expected healing period.

Who should consider this trial

Good fit: Ideal candidates are adults (age >18) with bone defects that do not compromise structural stability, who meet the device IFU criteria and can give informed consent.

Not a fit: Patients with local or systemic active infection, significant metabolic bone disease, severe degenerative conditions, unstable implantation sites requiring structural support, or risk of product migration are unlikely to benefit.

Why it matters

Potential benefit: If successful, Neocement® Inject P could offer a synthetic bone filler that supports faster and durable bone regeneration and may reduce the need for other graft materials.

How similar studies have performed: Other calcium phosphate–based bone substitutes have shown positive results for bone filling and gradual resorption, although clinical evidence specific to this Neocement® Inject P formulation is limited and being expanded by 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® 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.

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® Inject P; prospective observational clinical study; medical device; performance and safety; bone defects; real-world clinical data