Measuring Knee Laxity and Pivot Shift in ACL-Deficient Patients
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorArthroresearch LLC
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 18-65 years
Confirmed ACL tear by MRI or arthroscopic diagnosis
Able to provide informed consent
Disqualifiers
Prior major surgery on the affected knee
Multi-ligament knee injury
Active infection or inflammatory arthropathy
Inability to tolerate passive motion testing
Trial population
Study participants will be selected from patients being treated for ACL injury by orthopedic providers in the Atlanta metropolitan area. Participants will generally be identified through orthopedic clinic schedules, clinical referrals, or patients scheduled for ACL reconstruction.
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Clinician-graded pivot shift
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.
Time frame
Before ACL reconstruction, during the preoperative clinical exam and/or examination under anesthesia.2
Association Between RKT Knee Motion Measurements and Clinician-Graded Pivot Shift Grade
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.
Time frame
RKT testing at the preoperative study visit and pivot shift grading before ACL reconstructionSecondary outcomes
1
RKT Torque-Motion Hysteresis Curve Features
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.
Time frame
During RKT testing at the preoperative study visit before ACL reconstruction2
Effect of Knee Position on RKT Motion Measurements
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.
Time frame
During RKT testing at the preoperative study visit before ACL reconstruction3
Association Between Bone Morphology and Knee Instability Measurements
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.
Time frame
Existing imaging reviewed after enrollment and before data analysisSponsors and contacts
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Source ClinicalTrials.gov
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