Dynamic ACL Brace: In Vivo Kinematics
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Dynamic tibiofemoral kinematics during activities of daily living in ACL-deficient knees
研究概览
简要总结
The purpose of this study is to evaluate the effect of the Össur Rebound dynamic ACL brace on knee kinematics evaluated using dynamic stereo X-ray (DSX) imaging during functional activities. Brace performance will be evaluated before and after ACL reconstruction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
盲法说明
Investigators and participants cannot be blinded as to whether or not the brace is worn.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Unilateral, complete ACL (Anterior Cruciate Ligament) ruptures (must be documented by prior MRI)
- •No other concomitant lower extremity injuries and an uninjured contralateral limb
- •Acute ACL tears that will be scheduled for ACL reconstruction with Dr. Robert F. LaPrade
- •Minimal swelling and pain
- •Able and willing to perform the required study activities
排除标准
- •Previous surgery or significant injury to either knee
- •Relevant surgery, procedure, injury, or condition in the past two years which may affect knee pain or general movement patterns on either side
- •Diagnosis of osteoarthritis, rheumatoid conditions, cancers, or other conditions which may affect musculoskeletal health
- •Women who are pregnant, or trying/planning to become pregnant during the next 10 months
- •Known balance or vestibular disorders
- •Persons with a history of significant radiation exposure, whether occupational or medical in nature (Anyone with a history of medical radiation therapy, for cancer or other conditions, is excluded from the study. Those who have an annual occupational radiation exposure greater than 25mSv may not enroll.)
- •Persons with a pacemaker, hearing aid, aneurysm clip or artificial heart valve, or other forms of loose metal implants
- •Initial MRI exclusion criteria (assessed by clinical MRI obtained as standard of care at time of ACL injury diagnosis): concomitant injury, multi-ligamentous injury, significant meniscal damage
- •Allergy or sensitivity to silver or latex
- •Adults lacking capacity to consent for themselves
- •Post-Op Visit Exclusion Criteria
- •Participants who do not pass their return-to-sport test within 7-9 months of ACL-Reconstruction surgery will be excluded from the second phase of testing.
- •Participants who no longer pass the MRI screening at the time of Phase 2 testing (for example, who have a new loose metal implant), will be excluded from the MRI portion of the testing only.
研究组 & 干预措施
Knee Brace
ACL-reconstruction patients will be issued an Ossur Rebound ACL Brace at the time of enrollment in the study, prior to surgery. They will use this brace throughout their rehab and physical therapy.
Dynamic X-ray imaging of the knee will take place prior to surgery, and again upon clearance from physical therapy 7-9 months after surgery. The injured knee will be imaged with and without the brace, and the contralateral limb will be imaged for use as a control.
干预措施: Ossur Rebound ACL Brace (Device)
结局指标
主要结局
Dynamic tibiofemoral kinematics during activities of daily living in ACL-deficient knees
时间窗: <1wk (pre-operative)
This study will use dynamic stereo x-ray (pulsed bi-plane fluoroscopy) to measure the dynamic movements of the tibiofemoral joint during walking and stair-climbing, focusing on differences in anterior-posterior sliding and internal/external rotation of the tibia relative to femur, between the braced ACL-deficient knee, unbraced ACL-deficient knee, and the contralateral/uninjured knee.
Dynamic tibiofemoral kinematics during sports activities in ACL-reconstructed-knees
时间窗: 7-9 months (post-operative)
This study will use dynamic stereo x-ray (pulsed bi-plane fluoroscopy) to measure the dynamic movements of the tibiofemoral joint during dynamic movements and sports activities, focusing on differences in anterior-posterior sliding and internal/external rotation of the tibia relative to femur, between the braced ACL-reconstructed knee, unbraced ACL-reconstructed knee, and contralateral/uninjured knee.
次要结局
- Muscle contribution levels in braced vs unbraced knee(<1wk; 7-9 months)
- Percent symmetry in 3D motion capture kinematics and kinetics(<1wk; 7-9months)
- Subject Satisfaction(2 months; 4 months; 7-9 months)