Combined Effect of IPG Medical Charlie Laser and Bone Marrow Grafting on Cartilage Defects of the Knee
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- MRI
研究概览
简要总结
Laser pulsed energy will be delivered over an optical fiber to create channels into damaged cartilage of the knee or knees. The channels have a diameter of approximately 100 microns or less and an approximate depth of 1 millimeter or less. Bone marrow aspirate will then be delivered into the damaged joint.
详细描述
The creation of micro-channels into damaged knee cartilage will facilitate the movement of fluid into and out of the tissue to allow for more efficient nutrient diffusion. The addition of bone marrow aspirate will provide additional growth factor enriched nutrition to the tissue. The goal of this combination therapy is to facilitates the body's own reparative processes leading to improved patient well being.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Sham laser means laser not turned on. Sham marrow means incision in skin made but no marrow drawn. Patient under conscience sedation. MRI and outcomes measures independently measured.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Kellergren grading scale of 2 or 3 in at least one compartment of either or both knees with no compartment representing a stage 4 in either knee.
- •No significant MCL or LCL tear or laxity
- •No significant meniscal tear. ( i.e. bucket handle)
排除标准
- •Injection with the past 6 weeks
- •Stage 4 osteoarthritis in either knee
- •Uncontrolled Diabetes or any other metabolic syndrome
- •BMI greater than 28
- •Significant lower extremity deformity
- •Bilateral or tri compartmental Knee OA
- •Adults unable to consent
- •Individuals who are not yet adults (infants, children, and teenagers, age < 18)
- •pregnant women
- •Prisoners
- •Stage 4 osteoarthritis in either knee
- •Subjects, who, in the opinion of the investigator, for any reason other than those listed above, will not be able to complete the study per protocol.
研究组 & 干预措施
Sham
Under conscience sedation, a nick in the skin is made to mimic marrow aspiration. Laser inserted into knee joint but not turned on.
干预措施: Laser Cell Therapy (Procedure)
Laser Only
Under conscience sedation, a nick in the skin is made to mimic marrow aspiration. Laser fiber is inserted into knee over an 18 gauge needle and micro-channels are made into the damaged cartilage.
干预措施: Laser Cell Therapy (Procedure)
Laser plus Marrow
Under conscience sedation, a 10mL marrow aspiration is performed. Laser fiber is inserted into the knee over an 18 gauge needle and micro-channels are made into the damaged cartilage. After the channels are made, marrow aspirate is injected over the same 18 gauge needle.
干预措施: Laser Cell Therapy (Procedure)
结局指标
主要结局
MRI
时间窗: one year
Pre procedure MRI and post MRI is taken to measure disease modification
VAS Score
时间窗: one year
Pre procedure and post procedure Pain score
KOOS score
时间窗: one year
Pre procedure and post procedure Improvement in daily living and pain
Swiss Ball wall squat test
时间窗: one year
Swiss Ball wall squat test to asses functional recovery.
Treadmill Test
时间窗: one year
Pre procedure and post procedure, the patient will walk for 12 minutes with a gradual increase and a change in pain will be evaluated
次要结局
未报告次要终点