A Post-market Clinical Follow-up Investigation to Confirm the Performance and Safety of the Bone Substitute b.Bone in Extremities and Pelvis.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 135
- 试验地点
- 4
- 主要终点
- Performance of b.Bone by determining the radiographic healing/union after surgery.
研究概览
简要总结
This is a prospective, observational, non-randomized, multicenter, international post-market clinical follow-up investigation aiming to confirm the performance and safety of the bone substitute b.Bone after implantation in patients in isolation or as a graft expander requiring bone grafting for the treatment of surgically created bone defects or bone defects/voids resulting from traumatic injury to promote healing in the pelvis, upper and lower extremities. Patients enrolled in this clinical investigation will undergo orthopaedic surgery with b.Bone as recommended by the specialist and according to orthopaedic standard procedures. Patients will be evaluated preoperatively and at different time points after the surgery according to the standard practice of the sites. The expected schedule is at month 3, month 6 and month 12. Patients who require longer follow-up and could be subjected to metalwork removal will be evaluated up to 24 months. All safety data will be collected from patient inclusion to the end of the clinical investigation.
All study visits will coincide with any of the patient's routine clinical visits, without interfering with the investigator's clinical duties.
It is planned to enroll 135-193 patients from approximately 15 EU and UK sites.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Patient is undergoing a standard of care bone grafting with b.Bone for the treatment of surgically created bone defects or bone defects resulting from traumatic injury in the extremities and pelvis according to the approved IFU.
- •Male or female patient ≥ 18 years old.
- •Patients willing and able to attend the standard of care follow-up visits and procedures.
- •Patients who have provided consent to participate in the clinical investigation and to the processing of personal data.
排除标准
- •Patients with any conditions in which b.Bone is not indicated according to the contraindications defined in the IFU of b.Bone
- •Patients who are currently enrolled in another clinical investigation/study that would directly interfere with the current clinical investigation, except when the patient is participating in a purely observational study with no associated treatments.
- •Woman who is pregnant or breast-feeding.
- •Patients who, in the opinion of the Investigator, have an existing condition that could affect their ability to complete patient reported questionnaires or be compliant with the standard of care follow-up visits and examinations for the duration of the clinical investigation.
结局指标
主要结局
Performance of b.Bone by determining the radiographic healing/union after surgery.
时间窗: 12 months
Number and rate of patients with successful bone healing/union observable by X-ray or CT scan. Radiologic images will be evaluated by the surgeon according to the modified radiographic Union Scale for Tibial fractures (mRUST) classification or the modified Neer classification when applicable.
次要结局
- Clinical outcomes measured by patient-reported outcomes - Quality of Life(Baseline and 3, 6 and 12 months)
- Evaluate the safety of b.Bone during the clinical investigation period - rate of reinterventions(Up to 24 months)
- Evaluate the safety of b.Bone during the clinical investigation period - AE and SAE(Up to 24 months)
- Clinical outcomes measured by patient-reported outcomes - Pain(Baseline and 3, 6 and 12 months)