Evaluation of the Safety and Performance of the Neobone®: A Prospective Observational Study in Dental Area
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Safety Endpoint
研究概览
简要总结
This study aims to collect real-world clinical data to gather information on the performance and safety of the Neobone® 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.
详细描述
Neobone® is a synthetic and resorbable implantable synthetic calcium phosphate ceramic bone substitute, composed of hydroxyapatite and beta-tricalcium phosphate. The structures composed of these calcium phosphate ceramic structures are rapidly osseointegrated due to its chemical composition, which is similar to the mineral phase of the human bone, and due to the interconnected porosity allowing a total vascularization of the implant. Since beta-tricalcium phosphate is more soluble than hydroxyapatite, this biphasic composition enhances the ceramic resorption, allowing a resorption rate compatible with the physiology of bone cells. Neobone® is a single use, gamma radiation sterilized medical device.
Neobone® is a single use, gamma sterilized, implantable biodegradable medical device intended to be used in filling bony voids or gaps within the skeletal system that do not contribute to the structural stability of the bone, and in reconstructive dental and maxillofacial surgeries. These defects may arise from surgical procedures or result from osseous damage due to traumatic injury to the bone.
Neobone® is intended to be used in operating rooms by trained orthopaedic surgeons, as well as in dental offices or operating rooms by dentists and maxillofacial surgeons who have medical and technical knowledge in bone grafting. Neobone® is a class III medical device and is intended for long-term use and will be placed in contact with cancellous tissue and adjacent tissues through surgically invasive techniques.
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.
Participation in the study may provide a better understanding of treatment with Neobone® and potentially influence future clinical decisions, contributing to the continuous improvement of healthcare.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult males or females (age > 18 years old);
- •Patients who are able to sign an informed consent form (for data collection);
- •Patients undergoing reconstructive dental surgery and indicated for the use of Neobone®;
排除标准
- •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.
结局指标
主要结局
Safety Endpoint
时间窗: Visit 2 (moment after surgery), Visit 3 (7 ± 1 days), Visit 4 (6 months ±3 weeks), Visit 5 (12 months ±30 days) and Visit 6 (23 months ±30 days).
The assessment of adverse events (AE) and device deficiencies (DD) during the patient follow-up period relation to the medical device. This endpoint will be evaluated at each follow-up visit.
Clinical and radiographic performance endpoint:
时间窗: 6 months
\- Bone gain (augmentation volume in mm³) at 6 months, assessed by computed tomography (CBCT);
次要结局
- Radiographic bone density assessment(6 months)
- Technical success rate(moment after surgery)
- Quality of life assessment(Visit 1 (before surgery - baseline and enrolment), Visit 2 (moment after surgery), Visit 3 (7 ± 1 days), Visit 4 (6 months ±3 weeks), Visit 5 (12 months ±30 days) and Visit 6 (23 months ±30 days).)
- Pain level assessment(Visit 1 (before surgery - baseline and enrolment), Visit 2 (moment after surgery), Visit 3 (7 ± 1 days), Visit 4 (6 months ±3 weeks), Visit 5 (12 months ±30 days) and Visit 6 (23 months ±30 days).)
- Bone volume variation (in %) assessment(6 months)