Anterior Cruciate Ligament (ACL) TearNCT07688967
Measuring Knee Laxity and Pivot Shift in ACL-Deficient Patients
An observational study of Anterior Cruciate Ligament (ACL) Tear, run by Arthroresearch LLC at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anterior Cruciate Ligament (ACL) Tear
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jul 2026to Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Adults aged 18-65 years
- Confirmed ACL tear by MRI or arthroscopic diagnosis
- Able to provide informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Shaun K Stinton, PhD contact
United States1 site
Trailer
Atlanta, Georgia, 30324
Samantha J Beckley, PhD, 470-955-7069, s.beckley@arthroresearch.com
About this study
Official title: Objective Quantification of Knee Laxity Using a Robotic Knee Testing System and Correlation With Clinical Pivot Shift Grade 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.
Read the detailed description
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.
- Conditions
- Anterior Cruciate Ligament (ACL) Tear
- Keywords
- anterior cruciate ligament, pivot shift, knee instability, robotic knee testing
- Medical subject headings
- Lacerations
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: RKT testing at the preoperative study visit and pivot shift grading before ACL reconstruction
Secondary outcomes (3)
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.
Measured: During RKT testing at the preoperative study visit before ACL reconstruction
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.
Measured: During RKT testing at the preoperative study visit before ACL reconstruction
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.
Measured: Existing imaging reviewed after enrollment and before data analysis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2026
- Study start7 Jul 2026 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament (ACL) TearStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arthroresearch LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shaun K Stinton, PhD, Principal investigator, Arthroresearch LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07688967
- Sponsor's protocol ID
- 15940
- Status last verified
- Jun 2026
- First submitted
- 30 Jun 2026
- Last updated
- 7 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Objective Quantification of Knee Laxity Using a Robotic Knee Testing System and Correlation With Clinical Pivot Shift Grade in ACL-Deficient Patients
- ClinicalTrials.gov ID
- NCT07688967
- Acronym / sponsor ID
- 15940
- Conditions
- Anterior Cruciate Ligament (ACL) Tear
- Keywords
- anterior cruciate ligament, pivot shift, knee instability, robotic knee testing
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Arthroresearch LLCIndustry (pharma, biotech, devices)
- Study start
- 7 Jul 2026 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 7 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Adults aged 18-65 years
- Confirmed ACL tear by MRI or arthroscopic diagnosis
- Able to provide informed consent
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
3 secondary outcomes
RKT Torque-Motion Hysteresis Curve Features
Time frame: During RKT testing at the preoperative study visit before ACL reconstruction
Effect of Knee Position on RKT Motion Measurements
Time frame: During RKT testing at the preoperative study visit before ACL reconstruction
Association Between Bone Morphology and Knee Instability Measurements
Time frame: Existing imaging reviewed after enrollment and before data analysis
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shaun K Stinton, PhD contact
Shaun K Stinton, PhD principal investigator
Arthroresearch LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anterior Cruciate Ligament (ACL) Tear, run by Arthroresearch LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Samantha J Beckley, PhD (470-955-7069, s.beckley@arthroresearch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinician-graded pivot shift (time frame: Before ACL reconstruction, during the preoperative clinical exam and/or examination under anesthesia.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.