Prospective, Multi-Center, Observational Study Evaluating the Augmentation With Calcium Phosphate Cement (chronOS Inject) for Bone Defect After Internal Fixation of Proximal Tibial Fractures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Synthes GmbH
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Articular Subsidence
研究概览
简要总结
The primary objective of this study is to observe the safety, the radiological and clinical outcomes of chronOS Inject after having been used as bone void filler in internal fixation of proximal tibial fractures.
详细描述
The primary objective of this study was to observe the safety, the radiological and clinical outcomes of chronOS Inject after having been used as bone void filler in internal fixation of proximal tibial fractures. Secondary objectives were to assess the surgeon's satisfaction in using chronOS Inject and patient satisfaction post surgery.
The study was planned to be a multi-center, prospective, observational study. Patients with proximal tibial fractures of type Schatzker I - VI, AO-Müller-Orthopaedic Trauma Association (AO-OTA) 41, AO-OTA 42 with bone defect were assessed for eligibility to enter the study. Patients eligible for the study were followed over time to twelve months after surgery.
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
- •Subjects with closed proximal tibial fractures defined by : Tibia plateau, Schatzker I - VI, AO-OTA 41, AO-OTA 42 with bone defect
- •Skeletally mature adult 18 years or older, with close of growth plate at the time of surgery
- •Psychosocially, mentally and physically able to fully comply with this protocol including adhering to scheduled visits, treatment plan, completing forms, and other study procedures
- •Personally signed and dated informed consent document prior to any study-related procedures indicating that the patient has been informed of all pertinent aspects of the study
排除标准
- •Open fractures with severe soft tissue damage
- •Proximal tibial fractures with tumor or osteomyelitis
- •Any tibial anatomy or disease process that would interfere with deployment or performance of the device as defined by the surgeon
- •Osteopenia or Osteoporosis: if dual energy x-ray absorptiometry (DEXA) is required, exclusion will be defined as a DEXA bone density measured T score <=-1.0
- •Known history of Paget's disease, osteomalacia, or any other metabolic bone disease
- •Morbid obesity defined as a body mass index >40 kg/m2 or weight more than 50 kg over ideal body weight
- •Active malignancy. A patient with a history of any invasive malignancy (except non-melanoma skin cancer), unless treated with curative intent and there has been no clinical signs or symptoms of the malignancy >5 years
- •Known or documented history of communicable disease, including AIDS and HIV
- •Active Hepatitis (receiving medical treatment within two years)
- •Active systemic or local infection
- •Active rheumatoid arthritis, non-controlled diabetes mellitus, or any other medical condition(s) that would represent a significant increase in surgical risk or interfere with normal healing
- •Current or recent history (within last 2 years) of substance abuse (e.g., recreational drugs, narcotics, or alcohol)
- •Immunologically suppressed, or has received systemic steroids, excluding nasal steroids, at any dose daily for >1 month within last 12 months
- •Pregnant or planning to become pregnant during study period
- •Involved in study of another investigational product that may affect outcome
- •History of psychosocial disorders that could prevent accurate completion of self reporting assessment scales
- •Patients who are incarcerated
结局指标
主要结局
Articular Subsidence
时间窗: 12 months
Evidence of articular subsidence (collapse of surface pertaining to the joint) of ≥2 mm was assessed by the investigators
Mean Time to Union
时间窗: 12 months
Mean time to union was calculated based on the Kaplan-Meier estimator of the survivorship function
Fracture Union
时间窗: 12 months
Fracture union (complete bone healing) was assessed by the investigators based on anteroposterior and lateral X-rays
次要结局
- Anatomical Gradings Assessed Radiographically(12 months)
- Peri-operative Complications(12 months)
- Absorption Rate of Calcium Phosphate Cement(12 months)
- Patients Who Reached Full Weight Bearing(12 months)
- Total Range of Motion(12 months)
- Patient's Satisfaction(12 months)
- Surgeon's Satisfaction With the Product(Post-surgery)
- Extension Ability and Stability(12 months)
- SF-12 Short Form Health Survey Physical Composite Score (PCS)(12 months)
- SF-12 Short Form Health Survey Mental Composite Score (MCS)(12 months)
- VAS Leg Pain Intensity(12 months)
- VAS Leg Pain Frequency(12 months)
- Lysholm Knee Scale(12 months)