Measuring Knee Laxity and Pivot Shift in ACL-Deficient Patients
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.
Panoramica dello studio
Stato
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Stimato)
Contatti e Sedi
Contatto studio
- Nome: Samantha J Beckley, PhD
- Numero di telefono: 470-955-7069
- Email: s.beckley@arthroresearch.com
Backup dei contatti dello studio
- Nome: Shaun K Stinton, PhD
- Email: s.stinton@arthroresearch.com
Luoghi di studio
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Georgia
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Atlanta, Georgia, Stati Uniti, 30324
- Trailer
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Contatto:
- Samantha J Beckley, PhD
- Numero di telefono: 470-955-7069
- Email: s.beckley@arthroresearch.com
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Metodo di campionamento
Popolazione di studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Clinician-graded pivot shift
Lasso di tempo: Before ACL reconstruction, during the preoperative clinical exam and/or examination under anesthesia.
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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.
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Before ACL reconstruction, during the preoperative clinical exam and/or examination under anesthesia.
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Association Between RKT Knee Motion Measurements and Clinician-Graded Pivot Shift Grade
Lasso di tempo: RKT testing at the preoperative study visit and pivot shift grading before ACL reconstruction
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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.
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RKT testing at the preoperative study visit and pivot shift grading before ACL reconstruction
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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RKT Torque-Motion Hysteresis Curve Features
Lasso di tempo: During RKT testing at the preoperative study visit before ACL reconstruction
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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.
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During RKT testing at the preoperative study visit before ACL reconstruction
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Effect of Knee Position on RKT Motion Measurements
Lasso di tempo: During RKT testing at the preoperative study visit before ACL reconstruction
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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.
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During RKT testing at the preoperative study visit before ACL reconstruction
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Association Between Bone Morphology and Knee Instability Measurements
Lasso di tempo: Existing imaging reviewed after enrollment and before data analysis
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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.
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Existing imaging reviewed after enrollment and before data analysis
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Shaun K Stinton, PhD, Arthroresearch LLC
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Primo Inserito (Effettivo)
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Maggiori informazioni
Termini relativi a questo studio
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Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 15940
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