Measuring Knee Laxity and Pivot Shift in ACL-Deficient Patients

NCT07688967 | Not Yet Recruiting

• 1 other identifier: 15940
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anterior Cruciate Ligament (ACL) Tear

Keywords

anterior cruciate ligament; pivot shift; knee instability; robotic knee testing

Outcome Measures

Primary Outcomes (2)

• 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.

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

• 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.

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

Secondary Outcomes (3)

• 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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Arthroresearch LLC: lead

Study Sites (1)

Trailer

Atlanta, Georgia, 30324, United States

Location

MeSH Terms

Conditions

Lacerations

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Shaun K Stinton, PhD

  Arthroresearch LLC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Samantha J Beckley, PhD

CONTACT

470-955-7069; s.beckley@arthroresearch.com

Shaun K Stinton, PhD

CONTACT

s.stinton@arthroresearch.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2026
• First Posted: July 7, 2026
• Study Start: July 7, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: July 7, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)