Evaluation of the Safety and Performance of the Neocement®
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBioceramed
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Performance Endpoint
Bone consolidation on the surgery site (discrete variable: Yes or No), assessed by X-ray or CT scan.
Time frame
6 weeks; 3 months; 6 months and 12 months (if necessary)2
Safety Endpoint
The assessment of Adverse Events and Device deficiencies at least possibly related to Neocement® during the follow-up period of patients.
Time frame
6 weeks; 3 months; 6 months and 12 months (if necessary)Secondary outcomes
1
Quality of life measured through the Short Form Health Survey (SF-36) Questionnaire
Quality of life will be assessed during the patients' follow-up period. Patients will complete the SF-36 questionnaire to assess quality of life and to measure the Health Status during recovery. The SF-36 (Short Form Health Survey) is a questionnaire widely used to assess health-related quality of life. Composed of 36 questions, it covers eight main dimensions: physical functioning, limitations due to physical aspects, pain, general health status, vitality, social functioning, limitations due to emotional aspects and mental health. The score in each dimension allows a comprehensive analysis of the patient's perception of their physical and mental well-being, making it a valuable tool both in clinical research and in medical practice for monitoring the health of individuals and populations.
Time frame
6 weeks after surgery; 6 months2
Surgeon's Satisfaction survey on the medical device and Technical Success;
To evaluate the Technical Success rate, defined as the successful delivery of the bone substitute into the target defect without any malfunction of the delivery device or the bone substitute itself, and to collect usability feedback on the device during the surgical procedure through a Satisfaction survey. Information on the surgeon's satisfaction with the device under study should be collected post-operatively through a general questionnaire.
Time frame
6 weeks after surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Bioceramed
Lead sponsor
Local Health Unit Barcelos/Esposende, Public Health Unit
Collaborator
Source ClinicalTrials.gov