Bio-Integrative, Fiber-Reinforced Kneebar for Treating Subchondral Insufficiency of the Knee
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 10
- 试验地点
- 3
- 主要终点
- Knee injury and Osteoarthritis Outcome Scale Score (KOOS)
研究概览
简要总结
The OSSIOfiber® Trimmable Fixation Nails are indicated for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodesis and bone grafts in the presence of appropriate additional immobilization (e.g., rigid fixation implants, cast, brace). The hypothesis is that the use of OSSIOfiber® Trimmable Fixation Nails for treating subchondral insufficiency of the knee will result in improvement of patient-reported outcomes and imaging findings. The primary objective of this study is to evaluate the effectiveness of implanting bio-integrative OSSIOfiber® Trimmable Fixation Nails, organized in a bi-cortical rafter formation within the tibia or femur for the management of subchondral insufficiency. This use is not considered off-label because the TFNs are being used in the way they are intended to be used via FDA approval.
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
- •Has had knee pain in study knee lasting at least 3 months
- •Candidate for knee arthroscopy due to meniscal tear, loose body, unstable articular cartilage or mechanical symptoms.
排除标准
- •Current tobacco use or has quit within 3 months of study enrolment.
- •Substance abuse history.
- •Diabetes mellitus, HbA1c>8
- •High surgical risk due to pre-existing conditions.
- •Currently pregnant or has plans to become pregnant prior to surgery.
- •Active infection or history of chronic infection in study knee.
- •Will require concomitant procedures within study knee, including but not limited to ligament reconstruction, tendon repair, meniscus repair, microfracture, osteotomy, or osteochondral transplantation. (Meniscal tears, including chronic, are acceptable if no repair is required)
研究组 & 干预措施
Subchondral Insufficiency
Those who have subchondral insufficiency with tibial or femoral overload in the knee and are receiving the TFNs as standard of care.
干预措施: Ossiofiber® Trimmable Fixation Nail (Device)
结局指标
主要结局
Knee injury and Osteoarthritis Outcome Scale Score (KOOS)
时间窗: 6 months post-operatively
The overall KOOS score combines pain and function domains. KOOS is out 100, where 0 equates to extreme pain and 100 equates to no pain.
Knee injury and Osteoarthritis Outcome Score (KOOS)
时间窗: 3 months post-operatively
The overall KOOS score combines pain and function domains. KOOS is out 100, where 0 equates to extreme pain and 100 equates to no pain.
次要结局
- International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form(6 months post-operatively)
- Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR.)(6 months post-operatively)
- Veterans Rand-12 (VR-12) Health Survey Scale Score(6 months post-operatively)
- PROMIS Physical Function Score(6 months post-operatively)
- Incidence Assessments(Up to 24 month post-operatively.)
- Numeric Pain Reported Scale Score(6 months post-operatively)
- PROMIS Pain Interference Score(6 months post-operatively)
- PROMIS Depression Score(6 months post-operatively)
- Degree of knee ligament healing(6, 12, and 24 months)
研究者
Seth Sherman
Associate Professor
Stanford University