Clinical trial NCT06973226: Evaluation of the Safety and Performance of the Neocement®
Official title: Evaluation of the Safety and Performance of the Neocement®: A Prospective Observational Study in Orthopaedic Area
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
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
Lead sponsor: Bioceramed
Sponsor class: INDUSTRY
Collaborators: name: Local Health Unit Barcelos/Esposende, Public Health Unit
First posted: 2025-05-15
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Detailed description: Neocement® is an innovative calcium phosphate cement, blending the osteointegration and osteoconduction properties of calcium phosphates with the biological benefits of chitosan. This is a synthetic bone substitute primarily composed of calcium phosphates, specifically tetracalcium phosphate and beta-tricalcium phosphate.

Neocement® is intended for use in operating rooms by orthopaedic surgeons experienced in bone grafting techniques. It is suitable for long-term implantation, placed in contact with bone and surrounding tissues using surgical invasive methods. The device is specifically intended for adults (aged \> 18 years old) and can be used in multiple units depending on the lesion.

Neocement® is classified as a Class III medical device. Neocement® adheres to stringent regulatory standards for safety and effectiveness in bone regeneration applications. Neocement® is expected to be partially or totally resorbed, from the clinical available data, the expected effect can be predicted to occur after 6 months.

This study based on observations of clinical practice aims to collect clinical data to keep up to date the information on the performance and safety of the medical device when used in accordance with its intended use and current clinical applications. The results of the clinical study shall be used as clinical evidence for clinical evaluation of the device aiming submission to the new Medical Device Regulation (EU) 2017/745.

The post-market study is meant to identify and analyse emerging risks, ensure the continued acceptability of the benefit/risk ratio and also identify possible systematic misuse or unauthorized use of the medical device. This protocol does not include any planned new uses, new populations, new materials or design changes.

The results from the prospective observational post-market study will provide an evidence base for assessing the device's performance and safety after its market launch. Detecting real discrepancies in clinical performance between of the medical device early on can offer valuable opportunities to improve device design. This complements the data collected during the pre-market phases, thus improving patient selection. Active surveillance of the safety of medical devices, achieved through the continuous monitoring of vast sources of clinical data, is a priority in the field of medical devices, a requirement of MDR regulation No. 2017/745. This approach is crucial to achieving the objectives set, guaranteeing the safety and performance of the devices in circulation.

This observational post-market study will collect data relating to standard practice procedures, therefore there are no additional risks or direct benefits associated with participating in this registry for the patient.

Patients will be followed as per local standard medical practices of the centre for 1 year. Clinical data will be collected at 5 points in time: Visit 1 (15 ±2 days after surgery - baseline and enrolment), Visit 2 (6 weeks ±1 week), Visit 3 (3 months ±3 weeks), Visit 4 (6 months ±3 weeks) and if necessary, a Visit 5 (12 months ±30 days).

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.

Primary outcomes:
measure: Performance Endpoint
timeFrame: 6 weeks; 3 months; 6 months and 12 months (if necessary)
measure: Safety Endpoint
timeFrame: 15 days; 6 weeks; 3 months; 6 months and 12 months (if necessary)
Secondary outcomes:
measure: Quality of life measured through the Short Form Health Survey (SF-36) Questionnaire
timeFrame: 15 days after surgery; 6 months
measure: Surgeon's Satisfaction survey on the medical device and Technical Success;
timeFrame: 15 days after surgery
Other outcomes:
Locations:
city: Barcelos
country: Portugal
facility: Unidade Local de Saúde Esposende/Barcelos
Study officials:
References: