A Pilot Study to Augment™ Bone Graft Plus Evaluate the Safety of Allograft for Treatment of Osteochondral Defects (OCD) of the Knee
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- To evaluate the safety of Augment Bone Graft plus Allograft for treatment of osteochondral defects of the knee.
研究概览
简要总结
Is Augment Bone Graft plus Allograft safe to use for the treatment of osteochondral defects of the knee?
详细描述
Subjects will be 18 to 40 years with an osteochondral defects of the knee.They will be candidates for allograft and Augment Bone Graft will be added to the procedure. The safety of Augment Bone Graft plus allograft for osteochondral defects of the knee will be evaluated by type, frequency, severity and relatedness of adverse events to the device for a minimum of 24 weeks.Magnetic Resonance Imaging will be performed at 1,12 and 42 weeks to evaluate device integrity and surgical treatment of osteochondral defects. Computed tomography will be done at week 1 and week 24 to determine the healing status of the osteochondral defect.
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
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Prior Magnetic Resonance Imaging (MRI) evaluation or MRI on Screening.
- •Subjects with Grade III osteochondral defect (OCD) of femoral condyle.
- •Subjects with OCD > 1 cm.squared.
- •Independent and ambulatory pts.
- •Subjects from 18 to 40 years of age.
- •Subject with a stable knee joint and similar stability on the opposite knee.
- •Subject has knee x-ray with < 15 degrees of valgus and < 5 degrees varus.
- •No deformity from previous fractures of tibia or fibula.
- •Subject has an American Association of Anaesthetists physical status classification of 1 or
- •Subject must present with pain > 3.0 cm according to the Visual Analogue Score.
- •Subject has exhausted non operative treatment.
- •Allergy to yeast derived products.
- •Index knee has had cartilage repair in the last six months.
- •Subjects with osteoarthritis,inflammatory arthritis, rheumatoid arthritis and avascular necrosis of index knee.
- •Subject has contralateral knee complications which would interfere with rehabilitation
- •Subject has implanted metallic devices that would prevent Magnetic Resonance Imaging (MRI).
- •Subject has claustrophobia that would prevent MRI.
- •Subject has had a malignancy or is being treated for a malignancy.
- •Subject is physically or mentally compromised that would interfere with compliance.
- •Subject is a prisoner or transient.
- •Subject has a recent history (12 months) of alcohol abuse.
- •Subject is pregnant, able to become pregnant but not practising birth control.
- •Subject has an infection in the operative area.
- •Subject has scheduled surgery on the contralateral knee over the course of the study.
- •Subject requires another procedure in the index knee.
- •Subject has had steroid therapy in the past six months.
- •Subject is taking prescription pain medication for another indication other than the index knee.
- •Subject is using nicotine in any form.
排除标准
- 未提供
结局指标
主要结局
To evaluate the safety of Augment Bone Graft plus Allograft for treatment of osteochondral defects of the knee.
时间窗: 12 months
Collection of related adverse events
次要结局
- To utilize Magnetic Resonance Imaging to evaluate device integrity and surgical treatment of osteochondral defects of the knee.(12 months)
研究者
William Stanish
Medical Doctor
Nova Scotia Health Authority