[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04113759":3,"trial-entities:NCT04113759":139,"trial-summary:NCT04113759":144},{"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":21,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":41,"secondary_outcomes":65,"sex":91,"minimum_age":92,"maximum_age":93,"healthy_volunteers":94,"eligibility_criteria":95,"std_ages":113,"locations":115,"central_contacts":130,"overall_officials":133,"references":137,"see_also_links":138},"NCT04113759","19093005","Blood Flow Restriction Following Hip Arthroscopy","Postoperative Blood Flow Restriction Training Following Hip Arthroscopy: A Randomized Clinical Trial","RECRUITING","2028-01","2025-12","2025-12-05","2023-08-01","Rush University Medical Center","OTHER",false,"This study will be a prospective randomized, double-blinded, placebo-controlled trial of patients undergoing primary hip arthroscopy for FAIS and\u002For labral pathology. All patients who sign the consent form will be enrolled in the study and randomized to one of the two treatment arms. Follow-up will take place at 1-month, 3-months, 6-months, and 1-year.","The investigators propose using standardized strength testing, serial quadriceps measurements, and MRI to assess the efficacy of BFR training in increasing muscle hypertrophy following hip arthroscopy. Investigators will perform a randomized double-blinded placebo-controlled controlled trial of patients undergoing primary hip arthroscopy. Quadriceps strength will be measured with dynamometers at 3, 6, and 12 month time points, with Biodex strength testing at 6 and 12 months, postoperatively. Additionally, standardized circumferential leg measurements to assess quadriceps hypertrophy will be performed at 1, 3, 6 and 12-month time points. Patients will also undergo a hip MRI at 6 months postoperatively to quantify muscle size and appearance about the hip joint. Patient reported outcomes including standard outcomes measures at 3, 6, and 12 months and return to work\u002Fsport data will also be collected at standard time points. Patients will also be followed longitudinally for rates of reinjury, return to work, and return to sport.\n\nThis study will evaluate the efficacy of BFR therapy in the postoperative period of primary hip arthroscopy to improve muscle hypertrophy during the short-term rehabilitation period. This will be directly measured by strength testing with dynamometers and Biodex testing. Other metrics will include standard validated patient reported outcomes at 3, 6 and 12 month time points including hip disability and osteoarthritis outcome score (HOOS), Harris Hip score (HHS), visual analog scale (VAS) for pain, international hip outcome tool (iHOT-12), and Hip outcome score (HOS), and return to sport questionnaires. Standardized serial circumferential thigh measurements will also be recorded at each visit, in additional to a one time MRI at 6 months postoperatively.",[19,20],"Labral Tear, Glenoid","Femoral Acetabular Impingement",[],"INTERVENTIONAL","TREATMENT",[25],"NA",{"count":27,"type":28},56,"ESTIMATED",[30,36],{"type":31,"name":32,"description":33,"armGroupLabels":34},"BEHAVIORAL","Blood Flow Restriction Rehabilitative Therapy","BFR cuffs placed at the proximal thigh, just inferior to the greater trochanter.\n\nInflation time not to exceed 20 minutes. One BFR session per treatment. BFR exercise dosage: 4 sets of the following repetitions 30, 15, 15, 15, 30 second rest between sets, 1 min rest between exercises.\n\nProgress exercise if pain \\\u003C2\u002F10 on VAS and RPE \\\u003C5 on 0-10 scale. (Heerey et al), and no break down in form.",[35],"BFR Postoperative Rehabilitation",{"type":31,"name":37,"description":38,"armGroupLabels":39},"Sham BFR Rehabilitative Therapy","The schedule, type of exercises, repetition ranges, and other physical therapy interventions will be the same as the BFR experimental group - however a non-occlusive pressure will be applied with the cuff in the control group.",[40],"Control Group",[42,46,48,50,53,54,58,59,60,61],{"measure":43,"description":44,"timeFrame":45},"Quadriceps Strength","Will be measured with dynamometer","3 month time point",{"measure":43,"description":44,"timeFrame":47},"6 month time point",{"measure":43,"description":44,"timeFrame":49},"12 month time point",{"measure":51,"description":52,"timeFrame":47},"Biodex strength testing","Isokinetic strength testing",{"measure":51,"description":52,"timeFrame":49},{"measure":55,"description":56,"timeFrame":57},"Standardized circumferential leg meaurements","To assesss quadricep hypertrophy","1 month time point",{"measure":55,"description":56,"timeFrame":45},{"measure":55,"description":56,"timeFrame":47},{"measure":55,"description":56,"timeFrame":49},{"measure":62,"description":63,"timeFrame":64},"Muscle size and appearance about the hip joint","To be assessed via hip MRI postoperatively","6 months postoperatively",[66,69,70,71,74,75,76,79,80,81,84,85,86,89,90],{"measure":67,"description":68,"timeFrame":45},"Hip Disability and Osteoarthritis Outcome Score","Used to assess the patient's opinion about their hip and associated problems and to evaluate symptoms and functional limitations related to the hip during a therapeutic process.",{"measure":67,"description":68,"timeFrame":47},{"measure":67,"description":68,"timeFrame":49},{"measure":72,"description":73,"timeFrame":45},"Harris Hip Score","Gives a maximum of 100 points. Pain receives 44 points, function 47 points, range of motion 5 points, and deformity 4 points. Function is subdivided into activities of daily living (14 points) and gait (33 points). The higher the HHS, the less dysfunction.",{"measure":72,"description":73,"timeFrame":47},{"measure":72,"description":73,"timeFrame":49},{"measure":77,"description":78,"timeFrame":45},"Visual Analog Scale for pain","A 100-mm horizontal line on which the patient's pain intensity is represented by a point between the extremes of \"no pain at all\" and \"worst pain imaginable.\"",{"measure":77,"description":78,"timeFrame":47},{"measure":77,"description":78,"timeFrame":49},{"measure":82,"description":83,"timeFrame":45},"International hip outcome tool","Comprised of 33 questions relating to:\n\nSymptoms and Functional Limitations Sports and Recreational Activities Job-Related Concerns Social, Emotional, and Lifestyle Concerns",{"measure":82,"description":83,"timeFrame":47},{"measure":82,"description":83,"timeFrame":49},{"measure":87,"description":88,"timeFrame":45},"Hip Outcome Score","A self-administered questionnaire with a scoring system composed of 2 sub-scales. The Activities of Daily Living (ADL) sub-scale made of 19 items and a Sports sub-scale composed of 9 items.",{"measure":87,"description":88,"timeFrame":47},{"measure":87,"description":88,"timeFrame":49},"ALL","18 Years","40 Years",true,{"inclusion":96,"exclusion":101,"raw_text":112},[97,98,99,100],"Adult patients 18-40","English-speaking","Clinical and radiographic examination (MRI) consistent FAIS and\u002For labral pathology, and are schedule for primary hip arthroscopy","Written and informed consent for study participation",[102,103,104,105,106,107,108,109,110,111],"Patients younger than 18 or older than 40 years of age","Non-native English speaker","Revision surgery or prior history of ipsilateral hip or knee surgery","Inability to comply with the proposed follow-up clinic visits","Patients lacking decisional capacity","Patients with a history of deep vein thrombosis, pulmonary embolism, or known clotting disorder or hypercoagulable state","Pregnant or breast-feeding women. Pregnancy as determined by a positive pregnancy test prior to procedure. Females of childbearing potential must agree to use an acceptable birth control method during study participation.","Worker's compensation patients","Any clinically significant finding that would place the patient at health risk, impact the study, or affect the completion of the study","Any psychiatric illness that would prevent comprehension of the details and nature of the study and interfere with follow-up clinic visits","Inclusion Criteria:\n\n* Adult patients 18-40\n* English-speaking\n* Clinical and radiographic examination (MRI) consistent FAIS and\u002For labral pathology, and are schedule for primary hip arthroscopy\n* Written and informed consent for study participation\n\nExclusion Criteria:\n\n* Patients younger than 18 or older than 40 years of age\n* Non-native English speaker\n* Revision surgery or prior history of ipsilateral hip or knee surgery\n* Inability to comply with the proposed follow-up clinic visits\n* Patients lacking decisional capacity\n* Patients with a history of deep vein thrombosis, pulmonary embolism, or known clotting disorder or hypercoagulable state\n* Pregnant or breast-feeding women. Pregnancy as determined by a positive pregnancy test prior to procedure. Females of childbearing potential must agree to use an acceptable birth control method during study participation.\n* Worker's compensation patients\n* Any clinically significant finding that would place the patient at health risk, impact the study, or affect the completion of the study\n* Any psychiatric illness that would prevent comprehension of the details and nature of the study and interfere with follow-up clinic visits",[114],"ADULT",[116],{"facility":13,"status":8,"city":117,"state":118,"zip":119,"country":120,"contacts":121,"geoPoint":127},"Chicago","Illinois","60612","United States",[122],{"name":123,"role":124,"phone":125,"email":126},"Carla M Edwards, PhD","CONTACT","312-563-5735","carla_edwards@rush.edu",{"lat":128,"lon":129},41.85003,-87.65005,[131],{"name":132,"role":124,"phone":125,"email":126},"Carla M. Edwards, PhD",[134],{"name":135,"affiliation":13,"role":136},"Jorge Chahla, MD PhD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":140,"biomarkers":143},[141,142],"Femoral acetabular impingement","Labial tear",[],{"nct_id":4,"found":94,"summary":145,"prompt_version":154},{"design":146,"status":147,"heading":6,"summary":148,"follow_up":149,"word_count":150,"commitments":151,"compensation":152,"drugs_mentioned":153},"This is a randomized, double-blinded, placebo-controlled study with 56 participants. This means participants will be randomly assigned to either receive BFR therapy or a sham (inactive) BFR therapy, and neither you nor your doctors will know which one you are getting.","completed","This study is looking at how a therapy called Blood Flow Restriction (BFR) can help people recover after hip arthroscopy surgery for conditions like a labral tear or femoroacetabular impingement (FAI). BFR involves placing a cuff on your upper thigh during exercise to restrict blood flow. The study wants to see if this helps your quadriceps (thigh muscles) get stronger and bigger. You might be able to join if you are between 18 and 40 years old, speak English, and are scheduled for your first hip arthroscopy. The main goal is to measure your quadriceps strength at 3, 6, and 12 months after surgery. The study status is currently unclear, and it plans to enroll 56 participants.","You will be followed for 12 months after your surgery to assess quadriceps strength and other outcomes.",117,"You will have follow-up appointments at 1, 3, 6, and 12 months after surgery. These appointments will include strength testing, leg measurements, and potentially an MRI at 6 months.","Not stated in the trial record.",[],"v2"]