Neocement® Inject P to fill bone defects and support bone repair
Official title: Evaluation of the Safety and Performance of the Neocement® Inject P: A Prospective Observational Study in Orthopaedic Area
Run by Bioceramed · NCT06973239 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | Bioceramed Industry-sponsored |
| Locations | 1 site (Barcelos) |
| Status | Recruiting |
| Started | September 5, 2025 |
| Main results expected | June 2027 |
| Study ends | June 2027 |
| Registry record updated | June 18, 2026 |
| Trial ID | NCT06973239 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
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Unidade Local de Saúde Esposende/Barcelos
Barcelos, Portugal Recruiting
Study contacts
- Study coordinator: Alexandre Barros
- Email: clinicalstudies@bioceramed.com
- Phone: (+351) 253 573 460
Similar studies
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.