[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT03481010":3,"trial-entities:NCT03481010":188,"trial-summary:NCT03481010":191},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":38,"secondary_outcomes":43,"sex":67,"minimum_age":68,"maximum_age":69,"healthy_volunteers":70,"eligibility_criteria":71,"std_ages":88,"locations":91,"central_contacts":168,"overall_officials":176,"references":179,"see_also_links":187},"NCT03481010","20170796","Periacetabular Osteotomy With and Without Arthroscopic Management of Central Compartment Pathology","Periacetabular Osteotomy With and Without Arthroscopic Management of Central Compartment Pathology: A Multicenter Randomized Controlled Trial","RECRUITING","2030-12-31","2025-12","2025-12-30","2018-04-04","Ottawa Hospital Research Institute","OTHER",true,"At present, it is not clear whether performing a hip arthroscopy at the same time as a PAO improves patient outcomes after surgery compared to a PAO alone.\n\nThis research project will randomize patients to receive either a PAO alone, or a PAO and a hip arthroscopy at the same time.","Hip dysplasia is a developmental abnormality of the acetabulum (hip socket) that causes abnormal stresses inside the hip joint and leads to painful arthritis at a young age. Many patients develop painful symptoms in their hip before advanced arthritis occurs.\n\nThe periacetabular osteotomy (PAO) is a surgical procedure that reorients the acetabulum to reduce the stresses inside the hip joint. The PAO is very effective at improving symptoms and quality of life. However, some patients may have residual symptoms.\n\nFrequently, people with hip dysplasia will have an MRI done before their surgery, which helps to identify other the abnormalities inside their hip joint (e.g., labral tears). These abnormalities inside the joint cannot easily be addressed through PAO alone, however they can be addressed with hip arthroscopy. Hip arthroscopy is a separate minimally invasive surgical procedure that allows the surgeon to access the inside of the hip joint with a small camera and address any abnormalities.\n\nAt present, it is not clear whether performing a hip arthroscopy at the same time as a PAO improves patient outcomes after surgery compared to a PAO alone.\n\nThis research project will randomize patients to receive either a PAO alone, or a PAO and a hip arthroscopy at the same time. Patients will be followed for 2 years after surgery. Symptomatic differences between the two patient groups will be assessed to determine added benefit of the hip arthroscopy.",[19],"Hip Dysplasia",[],"INTERVENTIONAL","TREATMENT",[24],"NA",{"count":26,"type":27},204,"ESTIMATED",[29,34],{"type":30,"name":31,"description":32,"armGroupLabels":33},"PROCEDURE","PAO with hip arthroscopy","Participants who are randomized to the Scope-PAO group will receive central compartment hip arthroscopy in addition to the PAO.",[31],{"type":30,"name":35,"description":36,"armGroupLabels":37},"PAO without hip arthroscopy","Participants who are randomized to the \"PAO-only\" group will receive a Bernese Periacetabular Osteotomy (PAO) for treatment of hip dysplasia.",[35],[39],{"measure":40,"description":41,"timeFrame":42},"iHOT-33","Patient-reported quality of life will be the primary outcome used for comparison between the two treatment groups as measured by the International Hip Outcome Tool (iHOT-33). The iHOT-33 is a validated, self-administered quality of life assessment tool for young, active patients with hip symptoms.","24 months",[44,48,51,55,59,63],{"measure":45,"description":46,"timeFrame":47},"HOOS","Hip-specific symptoms and functional impairment will be compared using the Hip Disability and Osteoarthritis Outcome Score (HOOS). This 40-item patient reported outcome tool has been validated for use in patients with and without hip osteoarthritis and has shown good responsiveness, reliability and reproducibility in this patient population.","before surgery, 6 months, 12 months, 24 months after surgery",{"measure":49,"description":50,"timeFrame":47},"PROMIS Global 10","Global Health assessment will be compared using the PROMIS Global 10 Score. This 10-item tool assesses general domains of health related quality of life in the domains of physical, mental, and social well-being.",{"measure":52,"description":53,"timeFrame":54},"Operative time","Total operative time is expected to be longer in the \"Scope-PAO\" treatment group, however the average increase in time will be valuable information for future research assessing cost-effectiveness of this treatment strategy. Total operative time will be measured from the time the patient enters the operating room to the time the patient is ready for transfer to post-anesthetic care unit (PACU). This time interval represents the best assessment of the overall time cost to the health care system associated with the surgical procedure while avoiding confounding due to delays in transfer to PACU.","intra-operative",{"measure":56,"description":57,"timeFrame":58},"Hospital Length of Stay","Length of stay, measured in days, will be assessed from date of admission to date of discharge up to one month.","up to one month",{"measure":60,"description":61,"timeFrame":62},"Adverse Events","Adverse events will be assessed prospectively at the first and second post-operative visits using Sink et al.'s classification system that grades the complications based on required treatment and long-term morbidity.","2-4 weeks and 3 months after surgery",{"measure":64,"description":65,"timeFrame":66},"Cost-Effectiveness","The cost-effectiveness of the two study groups will be assessed prospectively using the Work Productivity and Activity Impairment Questionnaire. This 6-item validated questionnaire quantifies work impairments. Four scores are derived: percentage of absenteeism, percentage of presenteeism (reduced productivity while at work), an overall work impairment score that combines absenteeism and presenteeism and percentage of impairment in activities performed outside of work. Greater scores indicate greater impairment.","6 months, 12 months, and 24 months after surgery","ALL","16 Years","50 Years",false,{"inclusion":72,"exclusion":77,"raw_text":87},[73,74,75,76],"Skeletally mature patient undergoing Bernese periacetabular osteotomy for symptomatic acetabular dysplasia\u002Fhip instability","Pre-Operative MRI at 3T and\u002For gadolinium MR arthrogram","Age, 16-50 years old","Patient capable of giving informed consent",[78,79,80,81,82,83,84,85,86],"Prior hip\u002Fpelvis surgery of any kind on the surgical side","Prior hip arthroplasty surgery on either side","Radiographic evidence of arthritis (i.e. Tönnis grade =2)","Known connective tissue disorder (e.g. Ehlers-Danlos Syndrome, etc.)","Known neuromuscular disorder (e.g. Cerebral Palsy, Spina bifida, etc.)","Known skeletal dysplasia (e.g. Achondroplasia, Multiple Epiphyseal Dysplasia, etc.)","Cognitive impairment that prevents accurate completion of patient-reported outcome questionnaires.","Patient unable\u002Funwilling to complete all required follow-up visits","Concurrent proximal femoral osteotomy and\u002For surgical hip dislocation","Inclusion Criteria:\n\n* Skeletally mature patient undergoing Bernese periacetabular osteotomy for symptomatic acetabular dysplasia\u002Fhip instability\n* Pre-Operative MRI at 3T and\u002For gadolinium MR arthrogram\n* Age, 16-50 years old\n* Patient capable of giving informed consent\n\nExclusion Criteria:\n\n* Prior hip\u002Fpelvis surgery of any kind on the surgical side\n* Prior hip arthroplasty surgery on either side\n* Radiographic evidence of arthritis (i.e. Tönnis grade =2)\n* Known connective tissue disorder (e.g. Ehlers-Danlos Syndrome, etc.)\n* Known neuromuscular disorder (e.g. Cerebral Palsy, Spina bifida, etc.)\n* Known skeletal dysplasia (e.g. Achondroplasia, Multiple Epiphyseal Dysplasia, etc.)\n* Cognitive impairment that prevents accurate completion of patient-reported outcome questionnaires.\n* Patient unable\u002Funwilling to complete all required follow-up visits\n* Concurrent proximal femoral osteotomy and\u002For surgical hip dislocation",[89,90],"CHILD","ADULT",[92,105,116,127,137,149,158],{"facility":93,"status":8,"city":94,"state":95,"zip":96,"country":97,"contacts":98,"geoPoint":102},"Northwestern University","Chicago","Illinois","60611","United States",[99],{"name":100,"role":101},"Michael Stover, MD","CONTACT",{"lat":103,"lon":104},41.85003,-87.65005,{"facility":106,"status":8,"city":107,"state":108,"zip":109,"country":97,"contacts":110,"geoPoint":113},"William Beaumont Hospital","Royal Oak","Michigan","48073",[111],{"name":112,"role":101},"Ira Zaltz, MD",{"lat":114,"lon":115},42.48948,-83.14465,{"facility":117,"status":8,"city":118,"state":119,"zip":120,"country":97,"contacts":121,"geoPoint":124},"The Washington University","St Louis","Missouri","63130",[122],{"name":123,"role":101},"John C. Clohisy, MD",{"lat":125,"lon":126},38.62727,-90.19789,{"facility":128,"status":8,"city":129,"state":129,"zip":130,"country":97,"contacts":131,"geoPoint":134},"Hospital for Special Surgery","New York","10021",[132],{"name":133,"role":101},"Ernest Sink, MD",{"lat":135,"lon":136},40.71427,-74.00597,{"facility":138,"status":8,"city":139,"state":140,"zip":141,"country":142,"contacts":143,"geoPoint":146},"Children's Hospital of Eastern Ontario","Ottawa","Ontario","K1H 8L1","Canada",[144],{"name":145,"role":101},"Kevin Smit, MD",{"lat":147,"lon":148},45.41117,-75.69812,{"facility":13,"status":8,"city":139,"state":140,"zip":150,"country":142,"contacts":151,"geoPoint":157},"K1H8L6",[152,155],{"name":153,"role":101,"phone":154},"Geoffrey Wilkin, MD","613-737-8920",{"name":156,"role":101,"phone":154},"Research Team",{"lat":147,"lon":148},{"facility":159,"status":8,"city":160,"zip":161,"country":142,"contacts":162,"geoPoint":165},"CHU de Québec - Université Laval","Québec","G1J 1Z4",[163],{"name":164,"role":101},"Etienne Belzile, MD",{"lat":166,"lon":167},46.81228,-71.21454,[169,173],{"name":153,"role":101,"phone":170,"phoneExt":171,"email":172},"613-798-5555","10347","gwilkin@toh.ca",{"name":174,"role":101,"phone":154,"email":175},"Cheryl Kreviazuk","ckreviazuk@ohri.ca",[177],{"name":153,"affiliation":13,"role":178},"PRINCIPAL_INVESTIGATOR",[180,184],{"pmid":181,"type":182,"citation":183},"38768770","DERIVED","Beaule PE, Verhaegen JCF, Clohisy JC, Zaltz I, Stover MD, Belzile EL, Sink EL, Carsen S, Nepple JJ, Smit KM, Wilkin GP, Poitras S. The Otto Aufranc Award: Does Hip Arthroscopy at the Time of Periacetabular Osteotomy Improve the Clinical Outcome for the Treatment of Hip Dysplasia? A Multicenter Randomized Clinical Trial. J Arthroplasty. 2024 Sep;39(9 Suppl 1):S9-S16. doi: 10.1016\u002Fj.arth.2024.05.035. Epub 2024 May 18.",{"pmid":185,"type":182,"citation":186},"32811527","Wilkin GP, Poitras S, Clohisy J, Belzile E, Zaltz I, Grammatopoulos G, Melkus G, Rakhra K, Ramsay T, Thavorn K, Beaule PE. Periacetabular osteotomy with or without arthroscopic management in patients with hip dysplasia: study protocol for a multicenter randomized controlled trial. Trials. 2020 Aug 18;21(1):725. doi: 10.1186\u002Fs13063-020-04592-9.",[],{"nct_id":4,"conditions":189,"biomarkers":190},[19],[],{"nct_id":4,"found":15,"summary":192,"prompt_version":202},{"design":193,"status":194,"heading":195,"summary":196,"follow_up":197,"word_count":198,"commitments":199,"compensation":200,"drugs_mentioned":201},"This study is an interventional trial that will randomly assign participants to one of two treatment groups: PAO with hip arthroscopy or PAO without hip arthroscopy. It plans to enroll 204 participants.","completed","Periacetabular Osteotomy with and without Arthroscopy for Hip Dysplasia","This study is looking at whether adding a hip arthroscopy (a minimally invasive surgery using a small camera) at the same time as a Periacetabular Osteotomy (PAO) improves outcomes for people with hip dysplasia. Hip dysplasia is a condition where the hip socket is not formed correctly, which can lead to pain and arthritis. The PAO surgery reorients the hip socket to reduce stress. Sometimes, people with hip dysplasia also have other problems inside the hip joint, like labral tears, which a hip arthroscopy can address. This study will randomly assign participants to receive either a PAO alone or a PAO with a hip arthroscopy. Researchers will measure your hip function using a questionnaire called iHOT-33 after 24 months to see which approach works best. You may be able to join if you are between 16 and 50 years old, have symptomatic hip dysplasia requiring PAO, and have had a pre-operative MRI.","Participants will be followed for 2 years after surgery to assess their hip function.",152,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]