protocolSection identificationModule nctId: NCT06342843, orgStudyIdInfo id: SPLAsH, secondaryIdInfos id: NL81395.075.22, type: OTHER, domain: CCMO, briefTitle: Direct Superior Approach Versus PosteroLateral Approach in Total Hip Arthroplasty (SPLAsH), acronym: SPLAsH, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-13, primaryCompletionDateStruct date: 2026-08-30, completionDateStruct date: 2026-11-30, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Isala, class: OTHER, descriptionModule briefSummary: This study will compare postoperative pain, health related quality of life (HRQoL), function, rehabilitation, urinary incontinence, muscle atrophy and component positioning in total hip arthroplasty (THA) using the posterolateral approach (PLA) or the direct superior approach (DSA). In addition, the CT images will be used to validate a new metal artefact reduction technique., conditionsModule conditions: Osteoarthritis, Hip, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: multicenter, prospective, double blinded, randomized controlled intervention study, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 211, type: ESTIMATED, armsInterventionsModule interventions name: Total Hip Arthroplasty, outcomesModule primaryOutcomes measure: Hip disability and Osteoarthritis Outcome Score - Physical Function Short Form, secondaryOutcomes measure: Numeric Rating Scale (NRS), secondaryOutcomes measure: Short Form-12 (SF-12), secondaryOutcomes measure: Hip disability and Osteoarthritis Outcome Score (HOOS), secondaryOutcomes measure: Euro Quality of Life (EQ-5D), secondaryOutcomes measure: Global Rating of Change scale, secondaryOutcomes measure: Timed Up and Go test (TUG test), secondaryOutcomes measure: 40 meter self-paced walk test for hip osteoarthritis, secondaryOutcomes measure: Stair climb test, secondaryOutcomes measure: Step count application on iPhone, secondaryOutcomes measure: Muscle atrophy by using Computer Tomography (CT) scanner, secondaryOutcomes measure: Computer Tomography (CT) image with orthopedic metal artefact reduction (O-MAR), secondaryOutcomes measure: Postoperative cup position on Computer Tomography (CT) image, secondaryOutcomes measure: Comparing definite cup position with preoperative planned cup position, secondaryOutcomes measure: Comparing definite component position with surgeon's perioperative estimation of component position, secondaryOutcomes measure: overall image quality, secondaryOutcomes measure: image diagnostic confidence, secondaryOutcomes measure: metal artifacts on images, secondaryOutcomes measure: Incontinence Severity Index (ISI), secondaryOutcomes measure: Urinary Distress Inventory, Short Form (UDI-6), secondaryOutcomes measure: Patient Global Impression of Severity (PGIS), secondaryOutcomes measure: Incontinence Impact Questionnaire Short Form (IIQ-7), secondaryOutcomes measure: Incontinence after Total Hip Arthroplasty, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Amphia, status: NOT_YET_RECRUITING, city: Breda, state: Brabant, zip: 4818CK, country: Netherlands, contacts name: Stefan BT Bolder, MD, role: CONTACT, geoPoint lat: 51.58656, lon: 4.77596, locations facility: Medisch Centrum Leeuwarden, status: NOT_YET_RECRUITING, city: Leeuwarden, state: Friesland, zip: 8934AD, country: Netherlands, contacts name: Wierd Zijlstra, MD/PhD, role: CONTACT, geoPoint lat: 53.20139, lon: 5.80859, locations facility: Isala, status: RECRUITING, city: Zwolle, state: Overijssel, zip: 8000 GK, country: Netherlands, contacts name: Diederik de Boer, MSc., role: CONTACT, phone: 00316248117, email: die.de.boer@isala.nl, contacts name: Roelina Munnik, PhD, role: CONTACT, phone: 00316245375, email: r.munnik@isala.nl, contacts name: Harmen Ettema, MD/PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 52.5125, lon: 6.09444, hasResults: False