[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06845735":3,"trial-entities:NCT06845735":95,"trial-summary:NCT06845735":100},{"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":22,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":40,"secondary_outcomes":51,"sex":56,"minimum_age":57,"maximum_age":58,"healthy_volunteers":15,"eligibility_criteria":59,"std_ages":68,"locations":71,"central_contacts":90,"overall_officials":92,"references":93,"see_also_links":94},"NCT06845735","2099469","Absorbable vs Non-Absorbable Sutures for Hip Capsular Closure","Prospective Randomized Control Trial Comparing Absorbable Sutures to Non-Absorbable Sutures for Capsular Closures in Hip Arthroscopies","RECRUITING","2028-01-01","2026-05","2026-08-10","2024-03-22","University of Missouri-Columbia","OTHER",false,"The study is to prospectively compare absorbable sutures with non-absorbable sutures used for capsular repair during hip arthroscopic procedures. Major outcomes will be measured using three questionnaires ((1) International Hip Outcome Tool-12 (iHOT-12), (2) modified Harris hip score, (3) hip outcome score) in addition to the standard of care set of 9 questionnaires. The other major outcome will be any radiographic heterotrophic ossification at the 6-month follow-up time point.","1. International Hip Outcome Tool-12 is a 33-item patient-reported measure of health-related quality of life. It was designed to measure the impact of hip disease in young, active patients and to measure the effect of treatment of this disease.\n2. Modified Harris hip score is composed of 8 survey questions to determine gait, functionality and pain.\n3. The hip outcome score is 26 survey questions designed to asses the outcome of arthroscopic hip surgery for individuals with acetabular labral tears, including sports related questions and activities of daily living.\n\nStandard of care questionnaires will be given at follow up clinic visits. They are the:\n\n1. Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function\n2. PROMIS pain interference\n3. PROMIS Global Health\n4. Pain Visual Analog Scale\n5. Hip Single Assessment Numeric Evaluation (SANE)\n6. Modified Harris Hip Score\n7. Marx Activity Scale\n8. Tegner Activity Scale\n9. Surgical Satisfaction\n\nThese questionnaires will be given at preoperative, 6-week, 3-month, 6-month, 1 year, 2 years and any other follow-up visits in association with surgery.\n\nAny Radiographic images taken as standard of care (SOC) (post-operative radiographs are SOC) will be used in the study to determine Radiographic Heterotroph Ossification (HO) at 6 Months.",[19,20,21],"Labrum Injury of the Hip Joint","Hip Arthroscopy","Femoroacetabular Impingement Syndrome",[],"INTERVENTIONAL","TREATMENT",[26],"NA",{"count":28,"type":29},100,"ESTIMATED",[31,36],{"type":32,"name":33,"description":33,"armGroupLabels":34},"DEVICE","Non-Absorbable Sutures",[35],"Non-Absorbable Suture",{"type":32,"name":37,"description":38,"armGroupLabels":39},"Absorbable Suture","Absorbable suture",[37],[41,45,48],{"measure":42,"description":43,"timeFrame":44},"International Hip Outcome Tool-12 (IHOT-12)","12-item patient-reported measure of health-related quality of life. It was designed to measure the impact of hip disease in young, active patients and to measure the effect of treatment of this disease. Each of the 12 questions assess hip function and are scored from 0-100. 0 is a low score and 100 is high score indicating excellent function. The IHOT-12 is scored from taking the average of the 12 items of the tool and is scored 0-100, 0 being a low score and poor function and 100 being a high score indicating excellent function.","Preoperative to 12 months postoperative",{"measure":46,"description":47,"timeFrame":44},"Modified Harris Hip score","composed of 8 survey questions to determine gait, functionality and pain. Each question is scored with a separate scoring range. Higher scores indicate better function and less pain. The score is calculated by adding up the assigned points for each item, dividing by the max score (91), and multiplying by 100 to create a percentage. A higher score indicates a higher level of physical function, with 100% indicating full function.",{"measure":49,"description":50,"timeFrame":44},"Hip Outcome Score (HOS)","28-item assessment that is divided into 2 subscales: activities of daily living (HOS-ADL;19 items) and sports-related activities (HOS-Sports;9 items).\n\nOf the 2 subscales, each question contains five answer choices ranging from low function (score of 0) to high function (score of 4). The maximum score possible for the HOS-ADL is 68. A high score indicates high function, and a low score indicates low function.\n\nThe maximum score possible for the HOS-Sports is 36. A high score indicates high function, and a low score indicates low function.\n\nScores for each subscale range from 0% (least function) to 100% (most function). Results can be interpreted with the following: \\\u003C70 = poor result; 70-80 = fair, 80-90 = good, and 90-100 = excellent.",[52],{"measure":53,"description":54,"timeFrame":55},"Rate of Radiographic Heterotrophic Ossification","Any radiographic heterotrophic ossification at the 6-month follow-up time point.","Evaluated at 6-months postoperatively","ALL","18 Years",null,{"inclusion":60,"exclusion":63,"raw_text":67},[61,62],"Subjects 18 years of age and older.","Subject requiring surgical hip arthroscopic intervention for their hip pathology",[64,65,66],"Subjects less than 18 years of age.","Subjects with any other medical problem precluding anesthesia or surgery.","Unable to provide informed consent.","Inclusion Criteria:\n\n* Subjects 18 years of age and older.\n* Subject requiring surgical hip arthroscopic intervention for their hip pathology\n\nExclusion Criteria:\n\n* Subjects less than 18 years of age.\n* Subjects with any other medical problem precluding anesthesia or surgery.\n* Unable to provide informed consent.",[69,70],"ADULT","OLDER_ADULT",[72],{"facility":73,"status":8,"city":74,"state":75,"zip":76,"country":77,"contacts":78,"geoPoint":87},"Missouri Orthopaedic Institute","Columbia","Missouri","65201","United States",[79,84],{"name":80,"role":81,"phone":82,"email":83},"Vicki Jones, MEd, CCRP","CONTACT","573-882-7583","jonesvicki@health.missouri.edu",{"name":85,"role":86},"Steven F DeFroda, MD, MEng","PRINCIPAL_INVESTIGATOR",{"lat":88,"lon":89},38.95171,-92.33407,[91],{"name":80,"role":81,"phone":82,"email":83},[],[],[],{"nct_id":4,"conditions":96,"biomarkers":99},[97,98],"Femoral acetabular impingement","Hip Labral Tear",[],{"nct_id":4,"found":101,"summary":102,"prompt_version":111},true,{"design":103,"status":104,"heading":6,"summary":105,"follow_up":106,"word_count":107,"commitments":108,"compensation":109,"drugs_mentioned":110},"This interventional study will compare two different types of sutures in 100 participants. It is not specified if participants or researchers will know which suture type is used.","completed","This study is comparing two types of sutures, absorbable and non-absorbable, used during hip arthroscopy (a minimally invasive surgery for hip problems). The goal is to see which type of suture works better for closing the hip capsule after surgery for conditions like labrum injury or femoroacetabular impingement syndrome. Researchers will measure success by asking participants to complete several questionnaires about their hip pain, function, and quality of life over 12 months after surgery. They will also check for any abnormal bone growth (heterotrophic ossification) on X-rays at 6 months. You may be able to join if you are 18 or older and need hip arthroscopy. The study plans to enroll 100 participants, but its current status is unclear.","Participants will be followed for up to 2 years after their surgery, with primary outcomes measured for 12 months.",119,"Participants will complete several questionnaires before surgery and at 6 weeks, 3 months, 6 months, 1 year, and 2 years after surgery. Standard of care X-rays will also be used.","Not stated in the trial record.",[],"v2"]