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临床试验/NCT07688967
NCT07688967尚未招募不适用

Objective Quantification of Knee Laxity Using a Robotic Knee Testing System and Correlation With Clinical Pivot Shift Grade in ACL-Deficient Patients

Arthroresearch LLC1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2026年7月7日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
25
试验地点
1
主要终点
Clinician-graded pivot shift

研究概览

简要总结

The goal of this observational study is to learn whether the Robotic Knee Testing system can measure knee looseness in adults with an anterior cruciate ligament, or ACL, tear.

The main question it aims to answer is whether measurements from the Robotic Knee Testing system are related to the doctor's pivot shift exam grade.

Participants will complete one study visit before ACL reconstruction. During the visit, both knees will be tested in the Robotic Knee Testing system. Researchers may also review existing medical information and imaging.

详细描述

This study includes two parts. In Phase 1, researchers will adjust the Robotic Knee Testing system settings to identify testing conditions that are safe, tolerable, and able to reproduce knee motion similar to the pivot shift exam.

During Phase 1, the device will test how knee motion changes when the leg is placed in different positions. Researchers will evaluate whether tibial internal rotation and knee flexion angle change varus-valgus knee motion. They will also evaluate whether varus-valgus knee position and knee flexion angle change internal-external tibial rotation. These tests are intended to help identify device settings that may reproduce the coupled motion seen during a clinical pivot shift exam.

The robotic torque-motion curves will also be reviewed for abrupt changes, discontinuities, or "jumps." These findings may represent the knee moving from a stable position into an unstable position.

In Phase 2, participants will be tested using the finalized device settings from Phase 1. The device will apply controlled anterior-posterior, internal-external rotation, and varus-valgus movements while measuring knee motion in six degrees of freedom. Researchers will compare the robotic measurements with the pivot shift grade documented by the treating orthopedic surgeon.

When available, existing MRI or X-ray images may also be reviewed to evaluate whether knee bone structure is related to robotic laxity measurements or pivot shift severity. No additional imaging will be performed for this study.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults aged 18-65 years
  • Confirmed ACL tear by MRI or arthroscopic diagnosis
  • Able to provide informed consent

排除标准

  • Prior major surgery on the affected knee
  • Multi-ligament knee injury
  • Active infection or inflammatory arthropathy
  • Inability to tolerate passive motion testing
  • Pregnant or planning to become pregnant during the study period
  • Unable to provide informed consent

结局指标

主要结局

Clinician-graded pivot shift

时间窗: Before ACL reconstruction, during the preoperative clinical exam and/or examination under anesthesia.

Clinician-graded pivot shift from 0 to 3, obtained from the treating orthopedic surgeon's preoperative clinical exam and/or examination under anesthesia before ACL reconstruction.

Association Between RKT Knee Motion Measurements and Clinician-Graded Pivot Shift Grade

时间窗: RKT testing at the preoperative study visit and pivot shift grading before ACL reconstruction

Relationship between Robotic Knee Testing measurements of tibiofemoral motion and clinician-graded pivot shift grade from 0 to 3. RKT measurements may include tibial translation and rotation during robotic testing.

次要结局

  • RKT Torque-Motion Hysteresis Curve Features(During RKT testing at the preoperative study visit before ACL reconstruction)
  • Effect of Knee Position on RKT Motion Measurements(During RKT testing at the preoperative study visit before ACL reconstruction)
  • Association Between Bone Morphology and Knee Instability Measurements(Existing imaging reviewed after enrollment and before data analysis)

研究者

发起方
Arthroresearch LLC
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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