A Pre-market, Multi-center, International, Open-label, Single-arm Study to Evaluate the Safety and Performance of a Class III Medical Device (GreenBone Implant) for Surgical Repair of Long Bone Defects
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 16
- 试验地点
- 16
- 主要终点
- Number of Participants With Adverse Events
研究概览
简要总结
Multi-center, international, prospective, open-label, single-arm, first-in-human clinical investigation. The Patients enrolled in this clinical investigation will undergo a scheduled surgery for the treatment of long bone defects up to 6 cm using GreenBone Implant. After the surgery, the Patients will be monitored at pre-scheduled visits up to 12 months. Adverse events, pain, quality of life and functional parameters, as well as X-ray and CT scan, will be evaluated at scheduled follow-up visits. An independent Data Safety Monitoring Board (DSMB) will review the safety reports at regular intervals and Serious Adverse Events (SAE) as soon as reported, to protect Patients participating in the study. The initial phase of the study contemplates the treatment of bone defects up to 3 cm. An adaptive interim analysis will be performed when the first 7 Patients will have completed the 6-month follow-up visit. The DSMB will review the results of the interim analysis with respect to the primary endpoint (safety), and provide one of the following recommendations to the Sponsor: a) to stop the study for unacceptable frequency and severity of adverse events or b) to continue the study up to 25 Patients recruited and to include at least 5 Patients with a longer bone defect (> 3 cm up to 6 cm).
详细描述
This is a pre-market multi-centre, international, open label, single-arm, study to evaluate the safety and performance of a Class III medical device (GreenBone Implant) for the treatment of long bone defect. Bone defects can result from malformation, high-energy traumatic events, bone resection due to different pathologies such as tumors or infections, or from the treatment of complex non-unions. Current treatment of bone defects usually implies the use of bone grafts and/or biocompatible materials, to create a scaffold that bridges the defect. Autograft and Allograft are the treatments most currently used for large bone loss, but both treatments have significant disadvantages. These types of treatment carry the risk of transferring disease from animals and/or humans to the patient; there is also a risk of host local allergic reaction. Bone substitutes are devoid of the above risks and therefore they could be used alternatively to xenografts and allografts. GreenBone is a ceramic resorbable bone scaffold that has very similar structure to bone. It can be produced in large quantities, shaped easily and sterilised without losing its properties. Consequently, it is an ideal substitute that could be used to fill bone defects. This study will assess the safety of using GreenBone treatment of long bone defects up to 6 cm. Moreover it will assess its capacity of promoting new bone formation. The investigators will recruit 25 patients with long bone defect and instead of bovine xenograft we will use the GreenBone implant for the long bone reconstruction. Patients will be followed up for 12 months in total.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female Patients.
- •Patients aged ≥ 18 and ≤ 65 years old.
- •Patients requiring long bone defect reconstructions up to 3 cm, resulting from high-energy traumatic events, or from the treatment of complex bone non-unions in the extremities (arms and legs), or patients undergoing the second stage of the Masquelet technique.
- •Patients understanding the nature of the study and providing their informed consent to participation.
- •Patients willing and able to attend the follow-up visits and procedures foreseen by study protocol.
- •Please note: after interim analysis review by the DSMB, inclusion criteria n. 3 will be modified as follows (all Investigators will be notified by the Sponsor, and adequate training by Clinical Research Associate-CRA will be conducted):
- •Change of inclusion criteria n. 3: Patients requiring long bone defect reconstructions longer than 3 cm and up to 6 cm, resulting from high-energy traumatic events, or from the treatment of complex bone non-unions in the extremities (arms and legs), or patients undergoing the second stage of the Masquelet technique.
排除标准
- •Patients with bone infection at the time of enrolment.
- •Patients with bone malignant tumor(s) at the time of enrolment.
- •Patients who have been treated with chemotherapy or radiotherapy within 12 months before the enrolment.
- •Patients with concomitant infectious systemic diseases at the time of enrolment.
- •Patients with known inflammatory systemic diseases at the time of enrolment.
- •Patients with concomitant myeloproliferative disorders at the time of enrolment.
- •Patients currently treated with systemic immunosuppressive agents, excluding steroids.
- •Patients with active autoimmune disease.
- •Patients with a pre-existing calcium metabolism disorder (i.e. hypercalcemia).
- •Known hyperthyroidism or autonomous thyroid adenoma.
- •Patients with coagulopathy or bleeding disorders.
- •Patients who are not allowed to undergo the study procedures involving imaging (X-rays, CT scan) based on Investigator's judgement.
- •Patients with known or suspected allergy or hypersensitivity to the GreenBone Implant components.
- •Patients who are participating or have participated in other clinical studies within the 30 days before the study enrolment.
- •Patients identified by the Investigator to have intra-operative findings that may preclude conduct of study procedure.
- •Patients with occurrence of major intra-operative complications that require resuscitation or deviation from the planned surgical procedure.
- •Women who are pregnant or breast-feeding or who wish to become pregnant during the period of the clinical investigation and for three months later.
- •Female Patients of childbearing age (less than 24 months after the last menstrual cycle) who do not use adequate contraception.
结局指标
主要结局
Number of Participants With Adverse Events
时间窗: Overall study period up to 12 months
Evaluation of adverse events rate during the study period.
次要结局
- Reinterventions Number(between 1 and 12 months)
- Bone Union (Bone Healing) Evaluation Through Modified Lane and Sandhu Radiological Scoring System(At the end of visits 1,3,4,5,6,7,8 (respectively performed at screening and 1,2,3,6,9,12 months after the surgery, each visit is 1 day))
- Bone Regeneration Evaluation Through Modified Lane and Sandhu Radiological Scoring System(At the end of visits 1,3,4,5,6,7,8 (respectively performed at screening and 1,2,3,6,9,12 months after the surgery, each visit is 1 day))
- Evaluation of Pain(At the end of visits 1,3,4,5,6,7,8 (respectively performed at screening and 1,2,3,6,9,12 months after the surgery, each visit is 1 day))
- Evaluation of Quality-of-Life(At the end of visits 1,3,4,5,6,7,8 (respectively performed at screening and 1,2,3,6,9,12 months after the surgery, each visit is 1 day))
- Global Tolerability of Patient to Treatment(At the end of visits 3,4,5,6,7,8 (respectively performed 1,2,3,6,9,12 months after the surgery, each visit is 1 day))