Evaluation of the Safety and Performance of the Neocement® Inject P: 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 Neocement® Inject P 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
Neocement® Inject P is a synthetic bone substitute composed of calcium phosphates (tetracalcium phosphate and beta-tricalcium phosphate). It consists of two parts: a solid phase and an aqueous solution. The solid phase is composed of calcium phosphates (tetracalcium phosphate and beta-tricalcium phosphate) and chitosan (from animal origin), and the aqueous solution is composed of citric acid and glucose. The solid phase is delivered in a P-system (patented system) and the aqueous solution is delivered in a flask. Neocement® Inject P is a single use, biodegradable, gamma radiation sterilized medical device. Neocement® Inject P´s final composition is designed to improve bone quality and accelerate bone regeneration in cases of fractures or bone loss.
Neocement® Inject P is a single use, gamma sterilized, implantable biodegradable medical device. It is intended for the purpose of filling bony voids or gaps within the skeletal system that do not contribute to the structural stability of the bone. Additionally, it is utilized 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.
Neocement® Inject P 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.
Neocement® Inject P is a classe III medical device and is intended for long-term application and will be placed in contact with cancellous tissue and adjacent tissues by surgically invasive techniques.
This advanced biomaterial offers a reliable solution for addressing bone fractures and loss, demonstrating significant potential in enhancing patient outcomes through accelerated and durable bone regeneration.
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 Neocement® Inject P;
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
- 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).)
- Radiographic bone density assessment(6 months)
- 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 motnhs)