protocolSection identificationModule nctId: NCT06264076, orgStudyIdInfo id: 686340, secondaryIdInfos id: CIV-NO-23-09-043976, type: OTHER, domain: Eudamed CIV ID, briefTitle: Ligament Balancing in Total Knee Arthroplasty, acronym: BLIS-TKA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-16, sponsorCollaboratorsModule leadSponsor name: Oslo University Hospital, class: OTHER, collaborators name: Vestre Viken Hospital Trust, descriptionModule briefSummary: The goal of this interventional pilot study is to evaluate if performing ligament balancing on the medial collateral ligament (MCL) in a more systematical manner with a novel instrument can produce more objective and repeatable ligament lengthening in Total Knee Arthroplasty. The main questions it aim to answer are:1. Is it feasible to perform systematic ligament balancing on the MCL using a novel instrument?2. Can a novel instrument for ligament balancing acquire more objective and repeatable results, without risk of injury?Participants must consent prior to the surgery, but inclusion is only done once ligament balancing is indicated during surgery. Patients will be follow-up as standard protocol for Total Knee Arthroplasty patients at the hospital., conditionsModule conditions: Ligament; Laxity, Knee, conditions: Knee Osteoarthritis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Prospective, single-group, non-blind, interventional study, primaryPurpose: TREATMENT, maskingInfo masking: NONE, maskingDescription: Non-blind, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: A novel instrument for ligament balancing in total knee arthroplasty, outcomesModule primaryOutcomes measure: Is it feasible to perform systematic ligament balancing on the MCL using a novel instrument?, secondaryOutcomes measure: MCL-lengthening in millimeters after ligament balancing using the novel instrument, secondaryOutcomes measure: Demographic information - height (cm) - and how this parameters affects ligament balancing., secondaryOutcomes measure: Demographic information - weight (kg) - and how this parameters affects ligament balancing., secondaryOutcomes measure: Demographic information - age (years) - and how this parameters affects ligament balancing., secondaryOutcomes measure: Demographic information - sex (biologic, male/ female) - and how this parameters affects ligament balancing., secondaryOutcomes measure: Demographic information - co-morbidities (disease state) - and how this parameters affect ligament balancing., secondaryOutcomes measure: Patient reported outcome measures (PROM) using EQ-5D-5L, secondaryOutcomes measure: Patient reported outcome measures (PROM) using FJS-12, secondaryOutcomes measure: Patient reported outcome measures (PROM) using KOOS-12, eligibilityModule sex: ALL, minimumAge: 40 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Baerum Hospital, Vestre Viken Hospital Trust, city: Bærums Verk, state: Viken, zip: 1346, country: Norway, contacts name: Jarle Vik, MD, role: CONTACT, phone: 004793844926, email: jarle.vik@vestreviken.no, geoPoint lat: 59.94148, lon: 10.50273, locations facility: Oslo University Hospital, Ullevaal, city: Oslo, zip: 0450, country: Norway, contacts name: Lars HW Engseth, MD, role: CONTACT, phone: 004741254136, email: laengs@ous-hf.no, geoPoint lat: 59.91273, lon: 10.74609, hasResults: False