[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658518":3},{"organization":4,"outcomesModule":7,"designInfo":37,"detailedDescription":45,"studyPopulation":36,"armGroups":46,"interventions":55,"overallOfficials":36,"centralContacts":61,"locations":67,"responsibleParty":86,"collaborators":36,"id":88,"slug":89,"hasResults":90,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":36,"eligibilityCriteria":94,"healthyVolunteers":90,"sex":95,"minAge":96,"maxAge":97,"enrollmentInfo":98,"targetDuration":36,"studyType":101,"phases":102,"briefSummary":104,"conditions":105,"keywords":36,"overallStatus":70,"whyStopped":36,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":116},{"fullName":5,"class":6},"Uppsala University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":20,"otherOutcomes":36},[9,13,16],{"measure":10,"description":11,"timeFrame":12},"Hip abduction and external rotation strength in THA using direct lateral approach","Hip abduction and external rotation muscle strength following THA using a direct lateral approach will be assessed using a handheld dynamometer. Strength of the operated hip will be compared with the contralateral hip and expressed as a strength ratio. In participants undergoing THA through the direct lateral approach, strength outcomes will be compared according to postoperative gluteus medius tendon healing status (healed vs non-healed), as assessed by CTMA. Tendon retraction on CTMA will be used to classify tendon healing status.","Muscle strength preoperatively, at 3 months and 1 year after surgery.",{"measure":14,"description":15,"timeFrame":12},"Hip abduction and external rotation strength in THA using posterolateral approach","Hip abduction and external rotation muscle strength following THA using a posterolateral approach will be assessed using a handheld dynamometer. Strength of the operated hip will be compared with the contralateral hip and expressed as a strength ratio. In participants undergoing THA through the posterolateral approach, strength outcomes will be compared according to postoperative piriformis healing status (healed vs non-healed), as assessed by CTMA. Tendon retraction on CTMA will be used to classify tendon healing status.",{"measure":17,"description":18,"timeFrame":19},"Patient experiences based on interviews.","A qualitative content analysis will be performed to explore patients' experiences of the undergoing surgical procedure and the rehabilitation period, including thoughts, concerns, emotions, and expectations related to recovery and the social environment.","Interview 1 year after surgery.",[21,24,28,32],{"measure":22,"description":23,"timeFrame":12},"Hip abduction and external rotation strength in THA using direct lateral or posterolateral approach","Hip abduction and external rotation muscle strength following THA using a direct lateral or a posterolateral approach will be assessed using a handheld dynamometer. Strength of the operated hip will be compared with the contralateral hip and expressed as a strength ratio. Strength outcomes will be compared between the two groups (direct lateral and posterolateral).",{"measure":25,"description":26,"timeFrame":27},"Clinical score evaluation using Harris Hip Score (HHS) inquiry.","Comparison of HHS (0-100 rating scale, where higher scores indicate less disability and better hip health) between the two surgical approach groups (direct lateral and posterolateral approach) and between subgroups defined by tendon healing status (healed vs non-healed).","HHS preoperatively, at 6 weeks and 1 year after surgery.",{"measure":29,"description":30,"timeFrame":31},"Presence of Trendelenburg gait on clinical examination","The presence or absence of Trendelenburg gait will be assessed by clinical examination after total hip arthroplasty. The frequency of Trendelenburg gait will be compared between the two surgical approach groups (direct lateral approach and posterior approach). Trendelenburg gait will also be compared between subgroups defined by postoperative tendon healing status (healed vs non-healed), as assessed by computed tomography motion analysis (CTMA).","Preoperatively, at 6 weeks and 1 year after surgery.",{"measure":33,"description":34,"timeFrame":35},"Comparison of patient health satisfaction as defined with the inquiry SF-36.","Comparison of SF-36 outcomes between the two surgical approach groups (direct lateral and posterior approach) and between subgroups defined by tendon healing status (healed vs non-healed).","SF-36 preoperatively, at 3 months and 1 year after surgery.",null,{"allocation":38,"interventionModel":39,"interventionModelDescription":36,"primaryPurpose":40,"observationalModel":36,"timePerspective":36,"maskingInfo":41},"RANDOMIZED","PARALLEL","SCREENING",{"masking":42,"maskingDescription":36,"whoMasked":43},"SINGLE",[44],"PARTICIPANT","This is a prospective , randomized study including 2 groups of 20 patients each. One group will be operated using a direct lateral approach and the other group will be operated using a posterolateral approach. After THA surgery, participants will be followed with plain radiography, Computed Tomography Micromotion Analysis (CTMA), clinical score and evaluation with inquiry letters. By use of CTMA, the study will analyze whether the re-attached muscle to bone is stable or not under the post-operative time period. In order to identify distinct points of measurement on skeleton, the CTMA protocol will be used to create a radiostereometric image of the bone. Muscle attachments will be marked by metal sutures visible on CT, making it feasible to measure eventual migration. The study will investigate the relationship between potential failure of muscle healing and postoperative muscle strength, pain, limping, and functional outcomes.",[47,52],{"label":48,"type":49,"description":36,"interventionNames":50},"Direct lateral incision","ACTIVE_COMPARATOR",[51],"Procedure: Total hip arthroplasty",{"label":53,"type":49,"description":36,"interventionNames":54},"Posterolateral incision",[51],[56],{"type":57,"name":58,"description":59,"armGroupLabels":60,"otherNames":36},"PROCEDURE","Total hip arthroplasty","Marking of surgically detached tendons with metall markers. Radiostereometric analysis of the migration of the metall markers in different time points after surgery to evaluate healing or no healing of the tendons.",[48,53],[62],{"name":63,"role":64,"phone":65,"phoneExt":36,"email":66},"Dimitrios Sotiriou, Medical doctor","CONTACT","+46762810301","dimitrios.sotiriou@regiongavleborg.se",[68],{"facility":69,"status":70,"city":71,"state":36,"zip":36,"country":72,"countryCode":73,"cosmosGeoPoint":74,"geoPoint":79,"contacts":80},"Gävle hospital orthopaedic clinic","RECRUITING","Gävle","Sweden","SE",{"type":75,"coordinates":76},"Point",[77,78],17.14174,60.67452,{"lat":78,"lon":77},[81,84],{"name":82,"role":64,"phone":83,"phoneExt":36,"email":66},"Dimitrios Sotiriou","+46 26 158591",{"name":82,"role":85,"phone":36,"phoneExt":36,"email":36},"PRINCIPAL_INVESTIGATOR",{"type":87,"investigatorFullName":36,"investigatorTitle":36,"investigatorAffiliation":36,"oldNameTitle":36,"oldOrganization":36},"SPONSOR","100658518","randomized-study-of-surgical-approach-of-total-hip-arthroplasty-tha-100658518",false,"NCT07851597","Randomized Study of Surgical Approach of Total Hip Arthroplasty (THA).","Randomized Study of Surgical Approach of THA. CT\u002FRSA, Radiography, HHS and Muscle Strength.","Inclusion Criteria:\n\n* hip osteoarthritis as indication for THA surgery\n* use of cemented prosthetic Components\n\nExclusion Criteria:\n\n* symptomatic osteoarthritis on the contralateral hip\n* neuromuscular disorder\n* dementia\n* BMI\\>40\n* previous surgery on any hip","ALL","60 Years","80 Years",{"count":99,"type":100},40,"ESTIMATED","INTERVENTIONAL",[103],"NA","This study intends to analyze the healing process of the hip muscle system and to evaluate the functional recovery score after performing a cemented primary THA for osteoarthritis (OA).",[106],"Hip Arthroplasty","2026-09-24",{"date":109,"type":110},"2026-10-01","ACTUAL",{"date":112,"type":110},"2021-03-01",{"date":114,"type":100},"2028-12",{"name":5,"class":6},1]