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NCT Number: NCT07688967

Measuring Knee Laxity and Pivot Shift in ACL-Deficient Patients

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. Clinician-graded pivot shift

    Time frame: 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.

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

    Time frame: 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.

Secondary outcomes

  1. RKT Torque-Motion Hysteresis Curve Features

    Time frame: During RKT testing at the preoperative study visit before ACL reconstruction

    Torque-displacement and torque-rotation curves from robotic testing will be evaluated for features such as slope changes, curve area, discontinuities, or "jumps" that may reflect knee instability.

  2. Effect of Knee Position on RKT Motion Measurements

    Time frame: During RKT testing at the preoperative study visit before ACL reconstruction

    RKT measurements will be compared across different testing conditions, including tibial internal rotation angle, varus-valgus knee position, knee flexion angle, and preset torque thresholds, to identify settings associated with pivot-shift-like motion.

  3. Association Between Bone Morphology and Knee Instability Measurements

    Time frame: Existing imaging reviewed after enrollment and before data analysis

    Existing MRI or X-ray images may be reviewed to assess bone morphology, including posterior tibial slope and femoral-tibial plateau geometry, and compare these measures with RKT measurements and pivot shift grade.

Study contacts

Contact information is provided by the study sponsor or research team.

Samantha J Beckley, PhD

CONTACT

[email protected]

470-955-7069

Shaun K Stinton, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Arthroresearch LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 7, 2026
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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