Bridge-Enhanced ACL Repair-Safety Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Safety and tolerability of the BEAR® Implant
研究概览
简要总结
This study will assess the safety and early efficacy of a newly developed device, bridge-enhanced scaffold (MIACH™,) used to repair a torn anterior cruciate ligament (ACL.) Ten participants will undergo surgery with the new device (Experimental Group) and 10 will undergo a standard ACL reconstruction surgery (Control Group.)
详细描述
This is a first-in-human trial for evaluation of the safety (Primary Objective) and short-term efficacy (Secondary Objective) of the MIACH™ ACL scaffold and will be carried out in form of an observational study of 20 patients: 10 experimental and 10 control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Device Feasibility
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Complete ACL tear, confirmed by MRI
- •Time from injury to screening must be less than or equal to 90 days
- •ACL tissue present on pre-operative MRI
排除标准
- •(before surgery):
- •Prior surgery on affected knee
- •History of prior infection in affected knee
- •Regular use of tobacco or nicotine in any form
- •Use of corticosteroid within last 6 months
- •Ever underwent chemotherapy treatment
- •History of sickle cell disease
- •History of anaphylaxis
- •Any condition that could affect healing (Diabetes, inflammatory arthritis, etc)
- •Diagnosis of posterolateral corner injury (LCL complete tear, Biceps femoris tendon avulsion, tear of the arcuate ligament, tear of the popliteus ligament)
- •Diagnosis of Grade III medial collateral ligament injury
- •Diagnosis of complete patellar dislocation
- •Exclusion Criteria (during surgery):
- •ACL deemed normal on arthroscopic inspection
- •Time from injury to surgery is greater than 90 days (for Comparator group) and greater than 30 days (for Experimental group)
- •Experimental Group: Less than 50 percent of ACL remaining
- •Displaced bucket handle meniscal injury requiring repair
- •Diagnosis of full-thickness chondral injury on either condyle
- •Grade III medial collateral ligament injury
研究组 & 干预措施
ACL repair with MIACH scaffold
Patients will undergo ACL repair surgery using the newly developed MIACH scaffold
干预措施: ACL Repair with MIACH Scaffold (Device)
Standard ACL reconstruction
Patients will undergo a standard ACL reconstruction surgery
干预措施: Standard ACL Reconstruction (Procedure)
结局指标
主要结局
Safety and tolerability of the BEAR® Implant
时间窗: Surgery to 3-months post-op
To assess the safety (implant rejection, infection, joint effusion, muscle atrophy, knee laxity) and tolerability of the BEAR® implant
次要结局
- Muscle Atrophy(At 6-weeks post-op)
- Implant failure(At 3-months post-op)
- Inflammatory reaction(Surgery to 3-months post-op)
- Excessive Pain(Surgery to 3-months post-op)
- Anteroposterior (AP) knee laxity(At 6- and 12-months post-op)