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临床试验/NCT02913404
NCT02913404已完成不适用

Functional Biomechanical Outcome of ACL-reconstruction vs. ACL-reconstruction and Extra-articular-tenodesis in Patients

University of Pittsburgh2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2016年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
Change in KOOS

研究概览

简要总结

The purpose of this study is to asses functional biomechanical outcomes and patient reported outcome measures following single bundle ACL reconstruction (ACL-R) compared to single bundle ACL reconstruction and extra articular tenodesis (ACL-R+EAT).

详细描述

Screening Protocol All participants that express interest in the study will receive a screening interview that will determine eligibility for participation in the study. The screening of surgical patients will be performed by one of the clinical research coordinators in the clinic of Dr. Musahl.

Potential participants who pass the screening interview will be provided a copy of the informed consent form (in person or via email). The potential participant will review the consent form in detail with a member of the clinical team in order to ensure that the participant understands the information contained in the consent form and to provide an opportunity for the participant to ask questions about the study. If the potential participant then agrees to participate, the consent form will be signed by the participant and a member of the clinical team.

Surgical Protocol Baseline testing before surgery will consist of the IKDC objective and subjective score, KOOS score, Marx activity level, Lysohm Scale and VR-12. A radiologist will grade clinical MRI for ACL, meniscus, MCL, LCL, and ALC injury. Quantitative pivot shift testing will be performed under anesthesia using the PIVOT technology and inertial sensor. Intraoperative grading of ACL injury and concomitant injuries to the articular cartilage and meniscus will be performed. If deemed eligible final randomization will occur following intraoperative grading.

Standard single bundle anatomic ACL reconstruction will be performed for all subjects. Quadrupled hamstring tendon will be used with cortical fixation on femur and tibia. ACL-R+EAT will be performed as described by Marcacci with doubled hamstring tendon left attached at the pes anserinus, an anatomic tibial tunnel, staple fixation in the over the top position, routing of the graft superficial to the LCL, and staple fixation at Gerdy's tubercle. Concomitant tears to the menisci and their roots will be repaired as indicated.

Research Scans After surgery, approximately 6 months, subjects will undergo a CT scan on bilateral knees. The CT scan will be used to create volumetric models. These bone models will be matched to the dynamic biplane x-rays. Subjects will also undergo a research MRI scan on bilateral knees. The MRI scan will be used to generate models of the knee articular cartilage.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
14 Years 至 40 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Change in KOOS

时间窗: Visit 1 (up to 2 weeks prior to surgery) and Visit 2 (3-6 months after surgery)

The knee injury and Osteoarthritis Outcome Score is used to access the subjects view on the knee injury.

Change in IKDC subjective

时间窗: Surgical Visit

The international knee documentation committee's objective scale will be used to record the surgical procedure on the knee.

Change in Lysohm Scale

时间窗: Visit 1 (up to 2 weeks prior to surgery) and Visit 2 (3-6 months after surgery)

This scale will be used by the subject to report how the knee problems have affected management of daily life.

Change of joint kinematics

时间窗: Visit 1 (up to 2 weeks prior to surgery) and Visit 2 (3-6 months after surgery)

Outcome data includes: Joint contact path, functional joint space, anterior translation, varus-valgus rotation, and internal-external rotation will be obtained.

Demographic Questionnaire

时间窗: Visit 1 (up to two weeks prior to surgery)

This will include race, age, sex, height and weight.

Change in Marx Activity Scale

时间窗: Visit 1 (up to 2 weeks prior to surgery) and Visit 2 (3-6 months after surgery)

This scale will be used by the subject to report level of activity in the past year.

Change in VAS

时间窗: Visit 1 (up to 2 weeks prior to surgery) and Visit 2 (3-6 months after surgery)

This visual scale will be used by the subject to report the level of pain at the time of testing.

Change in VR-12

时间窗: Visit 1 (up to 2 weeks prior to surgery) and Visit 2 (3-6 months after surgery)

This scale will be used by the subject to measure health related to quality of life.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

William Anderst

Principal Investigator

University of Pittsburgh

研究点 (2)

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