NCT00708474撤回不适用
OsseoFit™ Porous Tissue Matrix™ Prospective Data Collection
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Site repair grade by MRI analysis
研究概览
简要总结
This study compares the fill of bone graft sites in the knee. It is hypothesized that harvest sites, voids, and defects caused by trauma that are treated with the OsseoFit™ Porous Tissue Matrix™ device will achieve a better fill grade than those treated with the conventional method.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The OsseoFit™ Porous Tissue Matrix™ is intended to be gently packed into the bony voids or gaps of the extremities and pelvis caused by trauma or surgery and are not intrinsic to the stability of the bony structure. These defects may be created from repetitive motion or traumatic injury to the bone or surgically created osseous defects for the harvest of bone. The device is a bone void filler that resorbs and is replaced with bone during the healing process. The device may be combined with sterile fluids such as saline or autogenous blood products such as blood, platelets, or bone marrow aspirate. The addition of these autogenous blood products does not compromise the performance of the device. Hydration with biologically beneficial sterile fluids can potentially have a positive influence on the healing and replacement of the device with bone.
排除标准
- •Infection at site
- •Hypercalcemia
- •Known allergies to bovine collagen
- •Current osteomyelitis at operative site
- •Systemic conditions which affect bone and/or wound healing
- •Known severe allergies manifested by history of anaphylaxis
- •Desensitization treatment injections to meat products, as injections may contain bovine collagen
- •Severe degenerative bone disease
研究组 & 干预措施
OsseoFit™
Experimental
Treatment of bone graft site with OsseoFit™ Porous Tissue Matrix™.
干预措施: OsseoFit™ Porous Tissue Matrix™ (Device)
Open
No Intervention
Treatment of bone graft site without OsseoFit™ Porous Tissue Matrix™.
结局指标
主要结局
Site repair grade by MRI analysis
时间窗: 6 months
次要结局
- Pain Score(3 months, 6 months, 1 year)
- Function Score(3 months, 6 months, 1 year)
- Incidence of adverse events(Any time)
- Site repair grade by MRI analysis(3 months, 1 year)
- Physical Evaluation(3 months, 6 months, 1 year)
研究者
研究点 (2)
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