Evaluation of the Safety and Performance of the Neocement®

NCT06973226 | Recruiting

• 1 other identifier: Neocement01
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to collect real-world clinical data to gather information on the performance and safety of the Neocement® 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.

Conditions

Bone Defects; Orthopaedic Surgery (30 Minutes or Longer)

Keywords

Neocement®; prospective observational clinical study; medical device; performance and safety; bone defects; real-world clinical data; post-market; calcium phosphates; synthetic bone substitute

Outcome Measures

Primary Outcomes (2)

• Performance Endpoint

  Bone consolidation on the surgery site (discrete variable: Yes or No), assessed by X-ray or CT scan.

  6 weeks; 3 months; 6 months and 12 months (if necessary)

• Safety Endpoint

  The assessment of Adverse Events and Device deficiencies at least possibly related to Neocement® during the follow-up period of patients.

  6 weeks; 3 months; 6 months and 12 months (if necessary)

Secondary Outcomes (2)

• Quality of life measured through the Short Form Health Survey (SF-36) Questionnaire

  6 weeks after surgery; 6 months

• Surgeon's Satisfaction survey on the medical device and Technical Success;

  6 weeks after surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The clinical study population consists of adult patients (aged \> 18 years old) undergoing orthopaedic surgery to treat bone defects. It is expected that clinical data will be collected from 80 patients implanted with the Neocement® product.

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bioceramed: lead
• Local Health Unit Barcelos/Esposende, Public Health Unit: collaborator

Study Sites (1)

Unidade Local de Saúde Esposende/Barcelos

Barcelos, Portugal

RECRUITING

Central Study Contacts

Alexandre Barros

CONTACT

(+351) 253 573 460; clinicalstudies@bioceramed.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2025
• First Posted: May 15, 2025
• Study Start: September 5, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: February 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)