Post-market Clinical Follow-up Study to Provide Safety, Performance and Clinical Benefits Data of the Biomet Cannulated Bone Screw System (Implants and Instrumentation) - A Retrospective/Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 51
- 试验地点
- 5
- 主要终点
- Device Safety Assessed Through the Incidence and Frequency of Revisions, Complications, and Adverse Events
研究概览
简要总结
The objective of this retrospective enrollment/prospective follow up study is to collect data confirming safety, performance, and clinical benefits of the Biomet Cannulated Bone Screw System (Implants and Instrumentation) when used according to the approved Indications for Use (IFU).
详细描述
The objective of this retrospective enrollment/prospective follow up study is to collect data confirming safety, performance, and clinical benefits of the Biomet Cannulated Bone Screw System (Implants and Instrumentation) when used according to the approved Indications for Use (IFU).
Safety will be established by recording the incidence and frequency of complications and adverse events. Relationship of the events to either implant or instrumentation should be specified.
Performance and clinical benefits will be assessed by analyzing fracture healing/fusion and the overall pain and functional performance of subjects who received the Biomet Cannulated Bone Screws by recording survey questions. Zimmer Biomet defines the expected performance rate for Cannulated Screws for long and small bone fractures to be a union rate of at least 81% at 8-12 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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 must be 18 years of age or older.
- •All patients operated on for the following indications:
- •Group 1, Small Cannulated Screws (4.0mm and smaller diameter) are intended for use in:
- •Fixation of small bones, including those in the foot, patella, ankle, wrist and elbow.
- •Arthrodesis of the foot, wrist and elbow.
- •Small and long bone osteotomies.
- •Fracture fixation of small bones, small bone fragments and long bones.
- •Group 2, Large Cannulated Screws (5mm and larger in diameter) are intended for use in:
- •Fixation of fractures in long bones and long bone fragments.
- •Long bone osteotomies (femur, tibia, foot, ankle, olecranon).
- •Arthrodesis and fracture fixation of the foot and ankle, such as Jones fractures of the fifth metatarsal, and Calcaneal fractures.
- •Group 3, Large Cannulated Screws (6.5mm and larger in diameter) are intended for use in:
- •Slipped capital femoral epiphysis
- •Pediatric femoral neck fractures
- •Tibial plateau fractures
- •SI joint disruptions
- •Intercondylar femur fractures
- •Subtalar arthrodesis
- •Fixation of pelvis and iliosacral joint
- •Patients must have the ability and willingness to follow instructions, including control of weight and activity levels.
- •Patient must have a good nutritional state.
排除标准
- •Infections.
- •Patient conditions including blood supply limitations, insufficient quantity or quality of bone.
- •Patients with mental or neurologic conditions who are unwilling or incapable fo following postoperative care instructions.
- •Foreign body sensitivity where material sensitivity is suspected or unknown, testing is to be completed prior to implantation of the device.
- •Patient is a prisoner.
- •Patient is a current alcohol or drug abuser.
- •Patient is known to be pregnant or breastfeeding.
- •Patient has a psychiatric illness or cognitive deficit that will not allow for proper informed consent.
结局指标
主要结局
Device Safety Assessed Through the Incidence and Frequency of Revisions, Complications, and Adverse Events
时间窗: Out to12+ months
Assessment of safety by recording and analyzing the incidence and frequency of revisions, complications, and adverse events.
次要结局
- Device Performance and Clinical Benefits Assessed by a Patient Questionnaire Case Report Form(Out to 12+ months)
- Device Performance and Clinical Benefits Assessed by a Follow-Up Analysis Case Report Form(Out to 12+ months)