NCT01450332Unknown不适用
A Single Arm, Prospective, Single Center, Study To Evaluate The Safety And Efficacy Of Tavor ACL Prosthesis In Patient With ACL Rupture
Tavor Ltd.2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2011年3月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Knee stability, as measured by a KT-1000 Arthrometer or Lachman test post procedure
研究概览
简要总结
The study is designed to evaluate the safety and efficacy of implanting the Tavor ACL prosthesis in patients with a ruptured ACL by improvement of healing kinetics as well as major adverse treatment events (AEs). it is designed to test the hypothesis that there is a difference in healing kinetics of ACL deficient knees treated by ACL reconstruction using autografts and those in which such procedure was performed with the Tavor prosthesis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is >= 18 years old
- •Patient has a ruptured ACL
- •Operated knee has full range of motion and no swelling
- •Patient understands the study requirements and the treatment procedures and rehabilitation and provides written Informed Consent before any study-specific tests or procedures are performed.
- •The patient commits to fully undergo the rehabilitation program and return for the scheduled post-operative follow-up visits at the clinic.
排除标准
- •Skeletal immaturity
- •Patient with:
- •Uncontrolled systemic hypertension
- •Severe uncontrolled Diabetes Mellitus
- •Epiphyses That Have Not Yet Closed
- •Periarticular or Patella Fracture
- •History of Metabolic Bone Disease (e.g.., Osteoporosis, Rickets)
- •Crystal deposition disease, e.g., gout
- •Inflammatory joint disease, e.g., rheumatoid arthritis
- •Severe degenerative joint disease
- •Known neoplastic disease
- •HIV positive
- •Current steroid therapy in excess of prednisone 5 mg/day
- •Other severe, life-threatening systemic disease or any medical condition that interferes with their ability to participate in a rehabilitation program
- •The subject has participated in, or is planned to participate in, any investigational drug or device study within the past 30 days and for the duration of this study.
结局指标
主要结局
Knee stability, as measured by a KT-1000 Arthrometer or Lachman test post procedure
时间窗: post procedure
No treatment emergent SAEs, including Adverse Events of Interest (AEOI), 3 months post procedure.
时间窗: 3 months post procedure
次要结局
- Rehabilitation period, defined by Post procedure period [weeks] to successful rehabilitation phase(3-6 months)
- Tegner Lysholm scores during the followup period(12 months post op)
- Long term safety: no device related SAEs 12 months post procedure.(12 months post op)
研究者
研究点 (2)
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