NCT04064710Unknown不适用
The Biological Allograft Chain Tissue Implant & Associated Manual Surgical Instrumentation: A Prospective, Post-Market Study
Lenoss Medical9 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2019年6月10日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 26
- 试验地点
- 9
- 主要终点
- Evaluate fracture stability assessed via subject- reported pain over time
研究概览
简要总结
A prospective, multi-center study evaluating allograft tissue as a bone void filler when implanted with Lenoss Medical manual surgical instrumentation in patients with painful vertebral compression fractures.
详细描述
Vertebral compression fractures can be associated with instability and severe, persistent pain and limitation of activities. This post market study is being conducted to assess fracture stability over time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Skeletally mature adult ≥ 50 years of age at the time of surgery;
- •Currently in an independent living environment;
- •One- or two- level, acute (within six weeks of injury), thoracic or lumbar (T6-L5) vertebral body compression fracture(s) with evidence of marrow edema by MRI/CT;
- •Adequate vertebral body height and geometry for insertion of the access instruments, as determined by the investigator and suitable candidate for standard kyphoplasty or vertebroplasty procedure;
- •VAS back pain score ≥ 70 mm on a 100 mm scale;
- •Has central pain over the spinous process upon palpation at the planned vertebral index level;
- •Has failed prior non-surgical medical management (i.e. - physical therapy, narcotic and/or non-narcotic medication)
- •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
- •More than two levels with a vertebral compression fracture;
- •Previous treated or untreated vertebral compression fracture at the to be treated level(s);
- •Uncorrectable coagulopathy;
- •Previous instrumented spinal surgery;
- •Significant vertebral collapse defined as > 70% of original vertebral height, or a burst, or pedicle fracture;
- •Degenerative scoliosis, defined as Cobb angle > 20° at any level;
- •Pre-existing neurological deficit or radicular pain that is not well defined or unstable;
- •Disabling back pain secondary to causes other than acute fracture;
- •Inability to walk or stand prior to sustaining the vertebral compression fracture;
- •Active systemic or local infection;
- •Known history of Paget's disease, osteomalacia, or any other metabolic bone disease;
- •Morbid obesity defined as a body mass index > 40 kg/m2;
- •Active malignancy. A patient with a history of any invasive malignancy (except nonmelanoma skin cancer), unless treated with curative intent and there has been no clinical signs or symptoms of the malignancy for more than 5 years;
- •Current or recent history (within last 2 years) of substance abuse (e.g., recreational drugs, narcotics, or alcohol);
- •Currently 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;
- •Pregnant or planning to become pregnant during the study period;
- •Involved in active spinal litigation;
- •Involved in a workers compensation case;
- •Prisoner or ward of the state;
- •Unable to undergo a MRI/CT procedure.
结局指标
主要结局
Evaluate fracture stability assessed via subject- reported pain over time
时间窗: 12 months
Subject-reported pain over time using the allograft tissue will be assessed using the Visual Analog Scale (VAS) for back pain on a scale of 0mm (no pain) to 100mm (worst pain imaginable).
次要结局
- Measure of Physical Disability Assessed via the Roland Morris Disability Questionnaire(12 months)
- Measurement of Quality of Life Assessed via the EuroQol Health Outcome Instrument (EQ-5D-3L)(12 months)
- Frequency of Implant Related Complications(12 months)
- Measurement of Activities of Daily Living Assessed via the Modified Tegner Activity Level Scale(12 months)
研究者
研究点 (9)
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