Outcomes Following Meniscal Repair With the BEAR Implant: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Incidence of Repair Failure
研究概览
简要总结
The bridge-enhanced ACL repair (BEAR) implant is a collagen-based scaffold loaded with whole blood. It is designed to promote healing in the setting of intraarticular knee pathology. This study would compare clinical outcomes and synovial fluid cytokine profiles in patients who undergo isolated meniscal repair with or without the BEAR implant.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of meniscus injury indicated for isolated repair, without concomitant ligament reconstruction or repair, cartilage repair procedure, or osteotomy.
排除标准
- •Patients who are undergoing meniscal repair for displaced bucket-handle meniscal tears
- •Patients with a history of blood-borne diseases including HIV, hepatitis B virus, hepatitis C virus, human T-lymphotropic virus, and syphilis
研究组 & 干预措施
BEAR Implant
Adult patients with meniscus injury indicated for isolated meniscus repair. In the experimental group, the BEAR Implant will be utilized in the repair procedure.
干预措施: Meniscal Repair Procedure (Procedure)
BEAR Implant
Adult patients with meniscus injury indicated for isolated meniscus repair. In the experimental group, the BEAR Implant will be utilized in the repair procedure.
干预措施: BEAR Implant (Device)
Standard Repair
adult patients with meniscus injury indicated for isolated meniscus repair. In the standard repair group, participants will undergo an isolated meniscus repair without the implant.
干预措施: Meniscal Repair Procedure (Procedure)
结局指标
主要结局
Incidence of Repair Failure
时间窗: Up to 1 Year Post-Procedure
Instances of failure of the meniscal repair.
Change in International Knee Documentation Committee (IKDC) Subjective Knee Form Score
时间窗: Baseline, 1 Year Post-Procedure
10-item assessment of knee-related symptoms at the present moment and over the previous 4 weeks. Each item is rated according to presence of symptoms. The raw score is the sum of responses and is rescaled to a total score ranging from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms).
Change in Lysholm Scale Score
时间窗: Baseline, 1 Year Post-Procedure
8-item assessment of knee-related activity and problems at the present moment. Each item is rated on a Likert-type scale. The total score is the sum of responses and ranges from 0 to 100, with higher scores indicating greater level of function/lower level of symptoms.
Change in Visual Analogue Scale (VAS) Score
时间窗: Baseline, 1 Year Post-Procedure
One-item assessment of pain on the current day. Pain is rated on a scale from 0 (no pain) to 10 (worst possible, unbearable, excruciating pain); the total score is the numerical rating.
次要结局
未报告次要终点