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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Evaluation of AdvanCore Bone Graft for Bone Healing

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• Using 3D printing to treat lower limb bone defects

  This study is testing a new 3D printing method to see if it can help people with lower limb bone defects heal better and get back to normal activities faster after surgery.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.