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Measuring Knee Laxity and Pivot Shift in ACL-Deficient Patients

30. juni 2026 opdateret af: Arthroresearch LLC

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

25

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

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Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Clinician-graded pivot shift
Tidsramme: 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.
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
Tidsramme: 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.
RKT testing at the preoperative study visit and pivot shift grading before ACL reconstruction

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
RKT Torque-Motion Hysteresis Curve Features
Tidsramme: 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.
During RKT testing at the preoperative study visit before ACL reconstruction
Effect of Knee Position on RKT Motion Measurements
Tidsramme: 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.
During RKT testing at the preoperative study visit before ACL reconstruction
Association Between Bone Morphology and Knee Instability Measurements
Tidsramme: 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.
Existing imaging reviewed after enrollment and before data analysis

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Arthroresearch LLC

Efterforskere

  • Ledende efterforsker: Shaun K Stinton, PhD, Arthroresearch LLC

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

7. juli 2026

Primær færdiggørelse (Anslået)

1. juli 2027

Studieafslutning (Anslået)

1. juli 2027

Datoer for studieregistrering

Først indsendt

30. juni 2026

Først indsendt, der opfyldte QC-kriterier

30. juni 2026

Først opslået (Faktiske)

7. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

7. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 15940

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Studerer et amerikansk FDA-reguleret enhedsprodukt

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Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Rivning af forreste korsbånd (ACL).

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