protocolSection identificationModule nctId: NCT06264999, orgStudyIdInfo id: 427976, briefTitle: Robotic Assisted Knee Arthroplasty - Retain the Anterior Cruciate Ligament or Not, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2026-04, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: St. Olavs Hospital, class: OTHER, collaborators name: Smith & Nephew, Inc., descriptionModule briefSummary: The goal of this clinical trial is to compare the function of the knee after retaining or sacrificing the anterior cruciate ligament in robotic assisted knee arthroplasty.The main questions it aims to answer are:Does retaining the anterior cruciate ligament improve postoperative gait? Participants will perform* Gait analysis* Stair performance test* CT based Micromotion analysis of the implant micromovement, conditionsModule conditions: Arthritis Knee, conditions: Arthroplasty, conditions: Gait Analysis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Journey II CR, interventions name: Journey II XR, outcomesModule primaryOutcomes measure: Preferred walking speed (meter/minute) after surgery, primaryOutcomes measure: CT-RSA measured maximum total point of motion(MTPM), secondaryOutcomes measure: evaluation of max walking speed(m/minute), secondaryOutcomes measure: stride length(cm), secondaryOutcomes measure: step length in mid stance phase (cm), secondaryOutcomes measure: single leg support time(s), secondaryOutcomes measure: double-leg support time(s), secondaryOutcomes measure: stair performance(s), secondaryOutcomes measure: Rating pain using NRS (Numeric Rating Scale)., secondaryOutcomes measure: KOOS-PS (Knee Injury and Osteoarthritis Outcome score), secondaryOutcomes measure: Clinical evaluation of range of motion ., secondaryOutcomes measure: Rating outcome using EQ-5D-5L(European quality of life index version 5D-5L),, secondaryOutcomes measure: IKSS (International Knee Society System knee and function score), secondaryOutcomes measure: FJS-12 (Forgotten Joint score), secondaryOutcomes measure: Clinical evaluation of Anteroposterior stability., secondaryOutcomes measure: Clinical evaluation of Mediolateral stability., otherOutcomes measure: A long leg X-Ray identifying outliers with Hip Knee Ankle angle Varus <-3 ºor Valgus >3 º, otherOutcomes measure: Presence of eminence fractures, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: St.Olavs Hospital, city: Trondheim, state: Trøndelag, zip: 7006, country: Norway, contacts name: Anders Sjøstrøm, MD, role: CONTACT, phone: +4772575241, email: anders.sjostrom@stolav.no, contacts name: Siri Bjørgen Winther, PhD, role: SUB_INVESTIGATOR, contacts name: Sølvi Liabekk Selli, role: SUB_INVESTIGATOR, geoPoint lat: 63.43049, lon: 10.39506, hasResults: False