[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06636045":3,"trial-entities:NCT06636045":116,"trial-summary:NCT06636045":119},{"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":24,"study_type":28,"primary_purpose":29,"phases":30,"enrollment_info":31,"interventions":34,"primary_outcomes":41,"secondary_outcomes":50,"sex":51,"minimum_age":52,"maximum_age":53,"healthy_volunteers":15,"eligibility_criteria":54,"std_ages":65,"locations":68,"central_contacts":78,"overall_officials":79,"references":83,"see_also_links":112},"NCT06636045","UKansasMCRI","Blood Flow Restriction Following ACLR w\u002FQuad Autograft","Effect of Blood Flow Restriction (BFR) on Rehabilitation Protocols Following Anterior Cruciate Ligament Reconstruction (ACLR) With Quadricep Autograft","ENROLLING_BY_INVITATION","2027-06","2024-08","2025-04-06","2024-09-05","University of Kansas Medical Center","OTHER",false,"This project is intended to acquire objective measurements of implementing BFR rehabilitation in ACL reconstructions to show any changes upon completion of the BFR protocol. The results in this study will hopefully represent valuable data in the support of using autografts for ACL reconstructions in high level athletes wanting a full recovery and return to high level of sport.\n\nIt has been speculated that use of autografts in ACL reconstructions leads to more quad weakness and muscle atrophy due to tendon harvesting. (Slone et al., 2015) More recently, BFR has shown promise in expediting the recovery and rehabilitation process post-surgically. By implementing BFR following ACL reconstructions with autografts, we hope to mitigate the major deterrent for autograft use and giving patients a more cost-effective approach to surgery. (Hughes et al., 2019)","Specific Aim 1 will identify the overall preservation of muscle and changes in body composition after injury and throughout surgical rehabilitation in athletes undergoing ACL reconstruction. It is hypothesized that implementing BFR rehabilitation protocols following ACL reconstruction with autografts will expedite recovery and return to sport and rescue of muscle tissue at the donor site.\n\nSpecific Aim 2 will monitor muscle strength and activation following ACL reconstruction with performance of standardized assessments at intervals. It is hypothesized that BFR implementation will show greater return to strength and enhanced muscle activation during testing.",[19,20,21,22,23],"Autografts","Blood Flow Restriction Therapy","Rehabilitation Outcome","Quadriceps Muscle Strength","Anterior Cruciate Ligament Reconstruction",[25,26,27],"blood flow restriction","anterior cruciate ligament reconstruction","quadriceps muscle strength","OBSERVATIONAL",null,[],{"count":32,"type":33},40,"ESTIMATED",[35],{"type":14,"name":36,"description":37,"armGroupLabels":38},"Not applicable- observational study","No intervention. Observational study.",[39,40],"BFR Group","Control Group",[42,46],{"measure":43,"description":44,"timeFrame":45},"Quad muscle Strength","Compare the muscle strength gain or loss between BFR group and control group","At 6 week post surgical timepoints",{"measure":47,"description":48,"timeFrame":49},"Return to sport","Compare the time it takes participants to return to sport in BFR group to control group","6 week intervals",[],"ALL","14 Years","40 Years",{"inclusion":55,"exclusion":58,"raw_text":64},[56,57],"Patient undergoing anterior cruciate ligament construction utilizing a quadriceps autograft","Age 14 - 40 years old",[59,60,61,62,63],"Comorbid conditions (i.e.: hypertension, diabetes, obesity, etc.)","Patient taking blood thinners or at risk of embolism","Revision anterior cruciate ligament construction","Allograft based reconstruction","Non-quadriceps graft","Inclusion Criteria:\n\n* Patient undergoing anterior cruciate ligament construction utilizing a quadriceps autograft\n* Age 14 - 40 years old\n\nExclusion Criteria:\n\n* Comorbid conditions (i.e.: hypertension, diabetes, obesity, etc.)\n* Patient taking blood thinners or at risk of embolism\n* Revision anterior cruciate ligament construction\n* Allograft based reconstruction\n* Non-quadriceps graft",[66,67],"CHILD","ADULT",[69],{"facility":70,"city":71,"state":72,"zip":73,"country":74,"geoPoint":75},"University of Kansas medical Center","Kansas City","Kansas","66160","United States",{"lat":76,"lon":77},39.11417,-94.62746,[],[80],{"name":81,"affiliation":13,"role":82},"Matthew Vopat, MD","PRINCIPAL_INVESTIGATOR",[84,88,91,94,97,100,103,106,109],{"pmid":85,"type":86,"citation":87},"35464074","BACKGROUND","Das A, Paton B. Is There a Minimum Effective Dose for Vascular Occlusion During Blood Flow Restriction Training? Front Physiol. 2022 Apr 8;13:838115. doi: 10.3389\u002Ffphys.2022.838115. eCollection 2022.",{"pmid":89,"type":86,"citation":90},"32232065","Lu Y, Patel BH, Kym C, Nwachukwu BU, Beletksy A, Forsythe B, Chahla J. Perioperative Blood Flow Restriction Rehabilitation in Patients Undergoing ACL Reconstruction: A Systematic Review. Orthop J Sports Med. 2020 Mar 25;8(3):2325967120906822. doi: 10.1177\u002F2325967120906822. eCollection 2020 Mar.",{"pmid":92,"type":86,"citation":93},"31301034","Hughes L, Rosenblatt B, Haddad F, Gissane C, McCarthy D, Clarke T, Ferris G, Dawes J, Paton B, Patterson SD. Comparing the Effectiveness of Blood Flow Restriction and Traditional Heavy Load Resistance Training in the Post-Surgery Rehabilitation of Anterior Cruciate Ligament Reconstruction Patients: A UK National Health Service Randomised Controlled Trial. Sports Med. 2019 Nov;49(11):1787-1805. doi: 10.1007\u002Fs40279-019-01137-2.",{"pmid":95,"type":86,"citation":96},"25543249","Slone HS, Romine SE, Premkumar A, Xerogeanes JW. Quadriceps tendon autograft for anterior cruciate ligament reconstruction: a comprehensive review of current literature and systematic review of clinical results. Arthroscopy. 2015 Mar;31(3):541-54. doi: 10.1016\u002Fj.arthro.2014.11.010. Epub 2014 Dec 25.",{"pmid":98,"type":86,"citation":99},"35800660","Sim K, Rahardja R, Zhu M, Young SW. Optimal Graft Choice in Athletic Patients with Anterior Cruciate Ligament Injuries: Review and Clinical Insights. Open Access J Sports Med. 2022 Jul 1;13:55-67. doi: 10.2147\u002FOAJSM.S340702. eCollection 2022.",{"pmid":101,"type":86,"citation":102},"35141538","Cognetti DJ, Sheean AJ, Owens JG. Blood Flow Restriction Therapy and Its Use for Rehabilitation and Return to Sport: Physiology, Application, and Guidelines for Implementation. Arthrosc Sports Med Rehabil. 2022 Jan 28;4(1):e71-e76. doi: 10.1016\u002Fj.asmr.2021.09.025. eCollection 2022 Jan.",{"pmid":104,"type":86,"citation":105},"36969302","Castle JP, Tramer JS, Turner EHG, Cotter D, McGee A, Abbas MJ, Gasparro MA, Lynch TS, Moutzouros V. Survey of blood flow restriction therapy for rehabilitation in Sports Medicine patients. J Orthop. 2023 Mar 13;38:47-52. doi: 10.1016\u002Fj.jor.2023.03.007. eCollection 2023 Apr.",{"pmid":107,"type":86,"citation":108},"37468645","Tang N, Eren M, Gurpinar T, Ozturkmen Y. A prospective randomized controlled study of hamstring and bone-free quadriceps tendons autografts in arthroscopic ACL reconstruction. Eur J Orthop Surg Traumatol. 2024 Jan;34(1):293-301. doi: 10.1007\u002Fs00590-023-03636-5. Epub 2023 Jul 19.",{"pmid":110,"type":86,"citation":111},"30874836","Mistry H, Metcalfe A, Colquitt J, Loveman E, Smith NA, Royle P, Waugh N. Autograft or allograft for reconstruction of anterior cruciate ligament: a health economics perspective. Knee Surg Sports Traumatol Arthrosc. 2019 Jun;27(6):1782-1790. doi: 10.1007\u002Fs00167-019-05436-z. Epub 2019 Mar 14.",[113],{"label":114,"url":115},"online sample size calculator","https:\u002F\u002Fwww.sealedenvelope.com\u002Fpower\u002Fcontinuous-superiority",{"nct_id":4,"conditions":117,"biomarkers":118},[23],[],{"nct_id":4,"found":15,"summary":29,"prompt_version":29}]